Abbreviations
ASA:
American Society of Anesthesiologists
ASGE:
American Society for Gastrointestinal Endoscopy
CT:
computed tomography
CTC:
computed tomography colonoscopy
ESGE:
European Society of Gastrointestinal Endoscopy
ICU:
intensive care unit
OR:
odds ratio
RCT:
randomized controlled trial
SEMS:
self-expandable metal stents
Introduction
Colorectal cancer is one of the most common cancers worldwide, particularly in the economically developed world [1]. Large-bowel obstruction caused by advanced colonic cancer occurs in 8 % – 13 % of colonic cancer patients [2]
[3]
[4]. The management of this severe clinical condition remains controversial [5]. Over the last decade many articles have been published on the subject of colonic stenting for malignant colonic obstruction, including randomized controlled trials (RCTs) and systematic reviews. However, the definitive role of self-expandable metal stents (SEMSs) in the treatment of malignant colonic obstruction has not yet been clarified. This evidence- and consensus-based clinical guideline has been developed by the European Society of Gastrointestinal Endoscopy (ESGE) and endorsed by the American Society for Gastrointestinal Endoscopy (ASGE) to provide practical guidance regarding the use of SEMS in the treatment of malignant colonic obstruction.
With the exception of one trial [6], all published RCTs on colonic stenting for malignant obstruction excluded rectal cancers, which were usually defined as within 8 to 10 cm of the anal verge, and colonic cancers proximal to the splenic flexure. Rectal stenting is often avoided because of the presumed association with complications such as pain, tenesmus, incontinence, and stent migration. Proximal colonic obstruction is generally managed with primary surgery, although there are no RCTs to support this assumption. Because of the aforementioned limitations, unless indicated otherwise the recommendations in this Guideline only apply to left-sided colon cancer arising from the rectosigmoid colon, sigmoid colon, descending colon, and splenic flexure, while excluding rectal cancers and those proximal to the splenic flexure, and other causes of colonic obstruction including extracolonic obstruction.
Methods
The ESGE commissioned this Guideline (chairs C. H. and J.-M. D.) and appointed a guideline leader (J. v. H.) who invited the listed authors to participate in the project development. The key questions were prepared by the coordinating team (E. v. H. and J. v. H.) and then approved by the other members. The coordinating team formed task force subgroups, each with its own leader, and divided the key topics among these task forces (see Appendix e1, available online).
Each task force performed a systematic literature search to prepare evidence-based and well-balanced statements on their assigned key questions. The coordinating team independently performed systematic literature searches with the assistance of a librarian. The Medline, EMBASE and Trip databases were searched including at minimum the following key words: colon, cancer, malignancy or neoplasm, obstruction and stents. All articles studying the use of SEMS for malignant large-bowel obstruction were selected by title or abstract. After further exploration of the content, the article was then included and summarized in the literature tables of the key topics when it contained relevant data (see Appendix e2, [Tables e1 – e5], available online). All selected articles were graded by the level of evidence and strength of recommendation according to the GRADE system [7]. The literature searches were updated until January 2014.
Each task force proposed statements on their assigned key questions which were discussed and voted on during the plenary meeting held in February 2014, Düsseldorf, Germany. In March 2014, a draft prepared by the coordinating team was sent to all group members. After agreement on a final version, the manuscript was submitted to Endoscopy for publication. The journal subjected the manuscript to peer review and the manuscript was amended to take into account the reviewers’ comments. All authors agreed on the final revised manuscript. The final revised manuscript was then reviewed and approved by the Governing Board of ASGE. This Guideline was issued in 2014 and will be considered for review in 2019 or sooner if new and relevant evidence becomes available. Any updates to the Guideline in the interim will be noted on the ESGE website: http://www.esge.com/esge-guidelines.html.
Recommendations and statements
Recommendations and statements
Evidence statements and recommendations are stated in bold italics.
General considerations before stent placement ([Table e1], available online)
General considerations before stent placement ([Table e1], available online)
Prophylactic colonic stent placement is not recommended. Colonic stenting should be reserved for patients with clinical symptoms and imaging evidence of malignant large-bowel obstruction, without signs of perforation (strong recommendation, low quality evidence).
Colonic stenting is indicated only in those patients with both obstructive symptoms and radiological or endoscopic findings suspicious of malignant large-bowel obstruction. Prophylactic stenting for patients with colonic malignancy but no evidence of symptomatic obstruction is strongly discouraged because of the potential risks associated with colonic SEMS placement. The only absolute contraindication for colonic stenting is perforation. In addition, colonic stenting is less successful in patients with peritoneal carcinomatosis and tumors close to the anal verge (< 5 cm) [8]
[9]
[10].
Increasing age and American Society of Anesthesiologists (ASA) classification ≥ III do not affect stent outcome (i. e. clinical success and complications) in several observational studies [11]
[12]
[13]
[14]
[15]
[16], although these are well-known risk factors for postoperative mortality after surgical treatment of large-bowel obstruction ([Table 6]) [17]
[18]
[19].
A contrast-enhanced computed tomography (CT) scan is recommended as the primary diagnostic tool when malignant colonic obstruction is suspected (strong recommendation, low quality evidence).
Table 6
Outcome of surgery according to age and American Society of Anesthesiologists (ASA) classification.
|
First author, year
|
Study population
|
Results
|
Study design
Level of evidence
|
|
Tekkis,
2004 [18]
|
Patients undergoing surgery for acute colorectal cancer obstruction (n = 1046)
|
Multivariate analysis of in-hospital postoperative mortality:
-
Age < 65 years: 5.4 %
-
Age 65 – 67 years: 13.1 %; OR 2.97 (95 %CI 1.26 – 7.08)
-
Age 75 – 84 years: 21.9 %; OR 4.31 (95 %CI 1.83 – 10.05)
-
Age ≥ 85 years: 27.0 %; OR 5.87 (95 %CI 2.27 – 15.14)
-
ASA I: 2.6 %
-
ASA II: 7.6 %; OR 3.32 (95 %CI 0.73 – 15.18)
-
ASA III: 23.9 %; OR 11.73 (95 %CI 2.58 – 53.36)
-
ASA IV – V: 42.9 %; OR 22.33 (95 %CI 4.58 – 109.68)
|
Nonrandomized prospective UK multicenter study
High quality evidence
|
|
Biondo,
2004 [17]
|
Patients undergoing emergency surgery for acute large-bowel obstruction (n = 234)
Colorectal cancer 82.1 %
Extracolonic cancer 4.7 %
Benign lesions 13.2 %
|
Univariate analysis of 30-day postoperative mortality:
-
Age ≤ 70 years: 10.7 % (14/131)
-
Age > 70 years: 29.1 % (30/103); P < 0.001
-
ASA I – II: 8.1 % (9/111)
-
ASA III – IV: 28.5 % (35/123); P < 0.001
Multivariate analysis of 30-day postoperative mortality:
|
No description of study design, most likely retrospective
Moderate quality evidence
|
|
Tan,
2010 [19]
|
Patients who underwent operative intervention for acute obstruction from colorectal malignancy (n = 134)
|
Perioperative morbidity rate: 77.6 %
Perioperative mortality rate: 11.9 %
Multivariate analysis of worse outcome (grade III – V complications, including death):
|
Retrospective analysis
Low quality evidence
|
CI, confidence interval; OR, odds ratio.
When malignant colonic obstruction is suspected, contrast-enhanced CT is recommended because it can diagnose obstruction (sensitivity 96 %, specificity 93 %), define the level of the stenosis in 94 % of cases, accurately identify the etiology in 81 % of cases, and provide correct local and distal staging in the majority of patients [5]
[20]. When CT is inconclusive about the etiology of the obstructing lesion, colonoscopy may be helpful to evaluate the exact cause of the stenosis.
Examination of the remaining colon with colonoscopy or CT colonography (CTC) is recommended in patients with potentially curable obstructing colonic cancer, preferably within 3 months after alleviation of the obstruction (strong recommendation, low quality evidence).
European studies, including three that are population-based, show that synchronous colorectal tumors occur in 3 % – 4 % of patients diagnosed with colorectal cancer [21]
[22]
[23]
[24]. Therefore, imaging of the remaining colon after potentially curative resection is recommended in patients with malignant colonic obstruction. Current evidence does not justify routine preoperative assessment for synchronous tumors in obstructed patients by CTC or colonoscopy through the stent. However, preoperative CTC and colonoscopy through the stent appear feasible and safe in these patients and there are presently no data to discourage their use in this population [25]
[26]
[27]
[28]. The role of positron emission tomography (PET)/CT in the diagnosis of synchronous lesions remains to be elucidated [29].
Colonic stenting should be avoided for diverticular strictures or when diverticular disease is suspected during endoscopy and/or CT scan (strong recommendation, low quality evidence). Pathological confirmation of malignancy by endoscopic biopsy and/or brush cytology is not necessary in an urgent setting, such as before stent placement. However, pathology results may help to modify further management of the stented patient (strong recommendation, low quality evidence).
When malignancy is suspected after diagnostic studies, a small number of patients will have a benign cause of obstruction. Two RCTs comparing SEMS as a bridge to surgery versus emergency surgery in patients with left-sided malignant obstruction reported benign obstructive lesions in 4.6 % (3/65) [30] and 8.2 % (8/98) [31] of the randomized patients. These benign colonic lesions that mimic malignancy are usually due to diverticular disease. Further evidence of the difficulty of this distinction is also reflected by a systematic review showing a 2.1 % prevalence of underlying adenocarcinoma of the colon in 771 patients in whom acute diverticulitis was diagnosed via CT scan [32]. Stent placement in active diverticular inflammation is associated with a risk of perforation and should therefore be avoided [33]. Furthermore, pathological confirmation of malignancy before emergency stent placement is often not feasible and is not required prior to colonic stent placement. Endoscopic biopsy and/or brush cytology for confirmation of malignancy should be obtained during the stent placement procedure, because it may be helpful in modifying the further management of the stented patient [34]
[35]
[36].
Preparation of obstructed patients with an enema to clean the colon distal to the stenosis is suggested to facilitate the stent placement procedure (weak recommendation, low quality evidence). Antibiotic prophylaxis in obstructed patients undergoing colon stenting is not indicated because the risk of post-procedural infections is very low (strong recommendation, moderate quality evidence).
There are no studies to date that have focused on bowel preparation before stent placement in obstructed patients. Symptomatic bowel obstruction is a relative contraindication to oral bowel cleansing. An enema is advisable to facilitate the stent placement procedure by cleaning the bowel distal to the stenosis.
Antibiotic prophylaxis before stent placement in patients with malignant colonic obstruction is not indicated because the risk of fever and bacteremia after stent insertion is very low. One prospective study analyzed 64 patients with colorectal cancer who underwent a stent procedure. Four of 64 patients (6.3 %) had a positive post-stenting blood culture and none of the patients developed symptoms of infection within 48 hours following stent placement. Prolonged procedure time was associated with transient bacteremia (36 vs. 16 minutes, P < 0.01) [37]. One other retrospective series of 233 patients undergoing colonic stent placement for malignant obstruction described that blood cultures had been drawn for unspecified reasons in 30 patients within 2 weeks after stent placement, showing bacteremia/fever in 7 patients (3 %), which was reported as a minor complication [15].
Colonic stent placement should be performed or directly supervised by an experienced operator who has performed at least 20 colonic stent placement procedures (strong recommendation, low quality evidence).
Two noncomparative studies addressed the learning curve of a single endoscopist performing colonic stent placement. Both showed an increase in technical success and a decrease in the number of stents used per procedure after performance of at least 20 procedures [38]
[39]. Two other retrospective series have shown that operator experience affects stenting outcome. The first reported significantly higher technical and clinical success rates when the stent was inserted by an operator who had performed at least 10 SEMS procedures [16]. The second showed a significantly increased immediate perforation rate when colonic stent placement was performed by endoscopists inexperienced in pancreaticobiliary endoscopy [15]. The authors of the latter article explained the lower immediate perforation rate by the skills that therapeutic ERCP endoscopists have in traversing complex strictures, understanding fluoroscopy, and deploying stents [15].
Technical considerations of stent placement ([Table e2], available online)
Technical considerations of stent placement ([Table e2], available online)
Colonic stent placement is recommended with the combined use of endoscopy and fluoroscopy (weak recommendation, low quality evidence).
SEMS placement can be performed by using either the through-the-scope (TTS) or the over-the-guidewire (OTW) technique. The majority of SEMS are inserted through the endoscope with the use of fluoroscopic guidance. The OTW technique is performed using fluoroscopic guidance with or without tandem endoscopic monitoring. Purely radiologic stent placement is performed by advancing the stent deployment system over a stiff guidewire, and technical and clinical success rates of 83 % – 100 % and 77 % – 98 %, respectively, have been reported in observational studies [40]
[41]
[42]
[43]
[44]
[45]. Retrospective studies that compared endoscopy combined with fluoroscopic guidance versus solely radiography for stent placement show comparable success rates, although with a trend towards higher technical success when the combined technique is used [16]
[46]
[47]
[48].
Stricture dilation either before or after stent placement is discouraged in the setting of obstructing colorectal cancer (strong recommendation, low quality evidence).
Although based on low quality evidence with small patient numbers, there are strong indications to believe that stricture dilation either just before or after colonic stent placement adversely affects the clinical outcome of stenting and particularly increases the risk of colonic perforation [8]
[12]
[15]
[49]. Pooled analyses, mainly based on retrospective data, also show increased risk of perforation after stricture dilation [47]
[50]
[51].
Covered and uncovered SEMS are equally effective and safe (high quality evidence). The stent should have a body diameter ≥ 24 mm (strong recommendation, low quality evidence) and a length suitable to extend at least 2 cm on each side of the lesion after stent deployment (weak recommendation, low quality evidence).
The clinician should be aware of specific features of the chosen stent that may affect the patient after insertion. Two meta-analyses comparing covered and uncovered SEMS for malignant colonic obstruction found similar technical success, clinical success, and overall complication rates. Uncovered SEMS showed significantly higher tumor ingrowth rates (11.4 % vs. 0.9 %) but were less prone to migrate than covered SEMS (5.5 % vs. 21.3 %) [52]
[53].
The diameter of the stent also seems to influence stent outcome. In mainly retrospective analyses, the use of small-diameter stents with a body diameter < 24 mm was associated with the occurrence of complications, in particular stent migration [15]
[54]
[55]
[56]. Stent length was not identified in observational studies as a risk factor for adverse stent outcome [8]
[11]
[16]
[45]. It is recommended to use a stent that is long enough to bridge the stenosis and to extend at least 2 cm on each side of the lesion, taking into account the degree of shortening after stent deployment [57]. Several studies, including one RCT, have shown no difference in outcomes (efficacy and safety) based on different stent designs [8]
[43]
[58]
[59]
[60]
[61].
Surgical resection is suggested as the preferred treatment for malignant obstruction of the proximal colon in patients with potentially curable disease (weak recommendation, low quality evidence). In a palliative setting, SEMS can be an alternative to emergency surgery (weak recommendation, low quality evidence).
Retrospective series have shown that SEMS may be successfully placed in malignant strictures located in the proximal colon (i. e. proximal to the splenic flexure) [8]
[16]
[62]
[63]
[64]. However, these data show conflicting results regarding SEMS outcome compared with stent placement in the left-sided colon [8]
[11]
[15]
[16]
[45]
[62]
[65]
[66]. Emergency resection is generally considered to be the treatment of choice for right-sided obstructing colon cancer. In this setting, primary ileocolonic anastomosis or ileostomy can be performed depending on the surgical risk of the patient [5]
[67]
[68].
SEMS placement is a valid alternative to surgery for the palliation of malignant extracolonic obstruction (weak recommendation, low quality evidence). The technical and clinical success rates of stenting for extracolonic malignancies are inferior to those reported in stenting of primary colonic cancer (low quality evidence).
Large-bowel obstruction caused by extracolonic malignancies is a different entity within colonic stenting and has been studied mainly retrospectively. Technical and clinical success rates of stenting extracolonic malignancies have been reported to range from 67 % to 96 % and from 20 % to 96 %, respectively [65]
[69]
[70]
[71]
[72]
[73]
[74]
[75], and are considered inferior to those reported in stenting of primary colonic cancer [8]
[55]
[70]
[74]. One retrospective comparison of SEMS for extracolonic versus primary colonic malignancy showed an increased complication rate in the extracolonic malignancy group (33 % vs. 9 %, P = 0.046), although this finding was not statistically significant in the multivariate analysis [74]. However, several larger series did not identify obstruction by extrinsic compression as a risk factor for complications [8]
[11]
[15]
[70]. It is generally advisable to attempt palliative stenting of extracolonic malignancies in order to avoid surgery in these patients who have a relatively short survival (median survival 30 – 141 days) [69]
[70]
[72]
[73].
There is insufficient evidence to discourage colonic stenting based on the length of the stenosis (weak recommendation, low quality evidence) or the degree of obstruction (strong recommendation, low quality evidence).
Few studies investigated the “stentability” of long obstructed segments [58]
[76]
[77]. However, in two retrospective studies that included a total of 240 patients, a better outcome was observed when SEMS were inserted in short obstructed segments [55]
[78]. One identified statistically significantly more technical failures (odds ratio [OR] 5.33) and clinical failures (OR 2.40) in stenoses > 4 cm [55].
The outcomes of SEMS placement for complete obstruction compared with subtotal obstruction are reported inconsistently in the literature. One comparative prospective study that specifically focused on this topic found similar technical and clinical success rates between both groups [79]. This was confirmed by more recently published large retrospective series [8]
[55]. However, in two observational studies significantly more complications were observed in the complete occlusion group (35 % and 38 % vs. 20 % and 22 %) [13]
[15]. Furthermore, multivariate analysis in one prospective multicenter study, which reported an 11 % overall perforation rate, identified complete obstruction as a risk factor for perforation (OR 6.88) [80].
Clinical indication: SEMS placement as a bridge to elective surgery ([Table e3], available online)
Clinical indication: SEMS placement as a bridge to elective surgery ([Table e3], available online)
Colonic SEMS placement as a bridge to elective surgery is not recommended as a standard treatment of symptomatic left-sided malignant colonic obstruction (strong recommendation, high quality evidence). For patients with potentially curable left-sided obstructing colonic cancer, stent placement may be considered as an alternative to emergency surgery in those who have an increased risk of postoperative mortality, i. e. ASA ≥ III and/or age > 70 years (weak recommendation, low quality evidence).
Eight systematic reviews with meta-analysis have been published in the last decade that compared preoperative stenting with emergency resection for acute malignant left-sided colonic obstruction [81]
[82]
[83]
[84]
[85]
[86]
[87]
[88]. Three of the seven RCTs published to date on this subject [30]
[31]
[89]
[90]
[91]
[92]
[93] were prematurely closed, including two because of adverse outcomes in the stent group [30]
[31] and one because of a high incidence of anastomotic leakage in the primary surgery group [92].
The most recent systematic review and meta-analysis evaluated the efficacy and safety of colonic stenting as a bridge to surgery (n = 195) compared with emergency surgery (n = 187) and considered only RCTs for inclusion ([Table 7]) [81]. All seven RCTs that focused on the postoperative outcome of SEMS and emergency surgery were included in this meta-analysis. The mean technical success rate of colonic stent placement was 76.9 % (range 46.7 % – 100 %) [81]. There was no statistically significant difference in the postoperative mortality comparing SEMS as bridge to surgery (10.7 %) and emergency surgery (12.4 %) [81]. The meta-analysis showed the SEMS group had lower overall morbidity (33.1 % vs. 53.9 %, P = 0.03), a higher successful primary anastomosis rate (67.2 % vs. 55.1 %, P < 0.01), and lower permanent stoma rate (9 % vs. 27.4 %, P < 0.01) [81].
No clear conclusions may be drawn about differences in costs between the two procedures. In the two RCTs that compared costs between SEMS as bridge to surgery and emergency surgery, stenting seems to be the more costly strategy [91]
[92]. Cost – effectiveness depends on the rate of stent complications, in particular perforation, and a greater benefit of stenting is expected in high risk surgical patients [94].
Table 7
Short-term outcomes of self-expandable metal stent (SEMS) placement as a bridge to elective surgery.
|
First author, year
|
Study population
|
Results
|
Study design
Level of evidence
|
|
Huang,
2014 [81]
|
Patients with acute left-sided malignant colonic obstruction
7 RCTs
Preoperative SEMS (n = 195)
Emergency surgery (n = 187)
|
Mean success rate of colonic stent placement: 76.9 % (46.7 % – 100 %)
Permanent stoma rate (P = 0.002):
-
SEMS as bridge to surgery: 9 % (9/100)
-
Emergency surgery: 27.4 % (26/95)
-
OR 0.28 (95 %CI 0.12 – 0.62); I
2 = 36 %
Primary anastomosis rate (P = 0.007):
-
SEMS as bridge to surgery: 67.2 % (131/195)
-
Emergency surgery: 55.1 % (103/187)
-
OR 2.01 (95 %CI 1.21 – 3.31); I
2 = 0 %
Mortality rate (P = 0.76):
-
SEMS as bridge to surgery: 10.7 % (12/112)
-
Emergency surgery: 12.4 % (14/113)
-
OR 0.88 (95 %CI 0.40 – 1.96); I
2 = 17 %
Overall complication rate (P = 0.03):
-
SEMS as bridge to surgery: 33.1 % (55/166)
-
Emergency surgery: 53.9 % (90/167)
-
OR 0.30 (95 %CI 0.11 – 0.86); I
2 = 77 %
Anastomotic leakage rate (P = 0.47):
-
SEMS as bridge to surgery: 4.1 % (8/195)
-
Emergency surgery: 5.9 % (11/187)
-
OR 0.74 (95 %CI 0.33 – 1.67); I
2 = 27 %
Wound infection rate (P = 0.004):
-
SEMS as bridge to surgery: 6.7 % (10/150)
-
Emergency surgery: 18.1 % (26/144)
-
OR 0.31 (95 %CI 0.14 – 0.68); I
2 = 0 %
Intra-abdominal infection rate (P = 0.57):
-
SEMS as bridge to surgery: 1.4 % (1/73)
-
Emergency surgery: 3.2 % (2/63)
-
OR 0.62 (95 %CI 0.12 – 3.19); I
2 = 0 %
|
Meta-analysis of RCTs
High quality evidence
|
|
Guo,
2011 [100]
|
Patients aged ≥ 70 years diagnosed with acute left-sided colonic obstruction
SEMS (n = 34)
Surgery (n = 58)
|
SEMS versus surgery
Overall rate of successful bridging with SEMS: 79 %
Mean time to elective surgery: 9 days (range 4 – 16)
Successful relief of obstruction: 91 % vs. 100 % (P = 0.09)
Primary anastomosis rate: 79 % vs. 47 % (P = 0.002)
Temporary stoma rate: 9 % vs. 53 % (P < 0.001)
Permanent stoma rate: 6 % vs. 12 % (P = 0.34)
Median length of hospital stay: 19 vs. 14 days (P = 0.06)
Acute mortality rate: 3 % vs. 19 % (P = 0.03)
Acute complication rate: 24 % vs. 40 % (P = 0.11)
|
Retrospective comparison
Low quality evidence
|
CI, confidence interval; OR, odds ratio; RCT, randomized controlled trial; SEMS, self-expandable metal stent.
From the above data, some advantages of SEMS as a bridge to surgery can be extracted. However, this has to be balanced with the oncological outcomes in patients with a curable colonic cancer. Potential concerns have been raised about impaired oncological outcome after SEMS placement in the patient with potentially curable colon cancer, particularly following stent perforation. Long-term oncological outcome comparing SEMS as a bridge to elective surgery versus acute resection was analyzed by three RCTs ([Table 8]) [90]
[92]
[95]. Although the study groups were small, with 15 to 26 patients in the stent arms, all three report higher disease recurrence rates in the SEMS group. This did not translate into a worse overall survival in any of these RCTs, but this may be related to short follow-up and small sample sizes [90]
[92]
[95]. These results are further supported by a larger comparative prospective cohort study showing significantly more local disease recurrences in the stent group compared with the primary surgery group in patients ≤ 75 years of age [96]. However, no difference in survival was seen between the two groups. One retrospective analysis reported a significantly lower 5-year overall survival and significantly increased cancer-related mortality in the SEMS as bridge-to-surgery group [97]. The use of SEMS and the occurrence of tumor perforation were identified to correlate with worse overall survival. Follow-up data of the Stent-in 2 trial also showed a significantly higher overall recurrence rate in the SEMS group compared with the surgery group (42 % vs. 25 %), which was even higher in the subgroup of patients who experienced stent-related perforation (83 %) [95].
Table 8
Oncological outcome of self-expandable metal stent (SEMS) placement.
|
First author, year
|
Study population
|
Results
|
Study design
Level of evidence
|
|
Sloothaak,
2013 [95]
[1]
|
Patients with acute left-sided colonic obstruction, proven malignancy, and curable disease
Preoperative SEMS (n = 26)
Emergency surgery (n = 32)
|
Median follow-up:
5-year overall recurrence rate (P = 0.027):
Locoregional recurrence rate (P = 0.052):
Cumulative incidence of overall recurrences (P < 0.01):
-
Patients with stent-perforation: 83 % (95 %CI 58 % – 100 %)
-
Non-perforated stent patients: 34 % (95 %CI 18 % – 65 %)
-
Emergency surgery: 26 % (95 %CI 14 % – 47 %)
5-year cumulative incidence of locoregional recurrences (P = 0.053):
-
Patients with stent perforation: 50 % (95 %CI 22 % – 100 %)
-
Non-perforated stent patients: 10 % (95 %CI 3 % – 28 %)
-
Emergency surgery: 11 % (95 %CI 3 % – 41 %)
|
Follow-up data of RCT [31]
Moderate quality evidence
|
|
Tung,
2013 [90]
|
Patients with obstructing left-sided colon cancer
Preoperative SEMS (n = 24)
Emergency surgery (n = 24)
|
Median follow-up (P = 0.083):
Operation with curative intent (P = 0.01):
Lymph node harvest (P = 0.005):
Overall recurrent disease (P = 0.4):
5-year overall survival rate (P = 0.076):
5-year disease-free survival rate (P = 0.63):
|
Follow-up data of RCT [93]
Moderate quality evidence
|
|
Alcantara,
2011 [92]
|
Patients with complete intestinal obstruction due to tumor in the left colon
SEMS as bridge to surgery (n = 15)
Intraoperative colonic lavage with primary anastomosis (n = 13)
|
Overall mean follow-up: 37.6 months
No difference in overall survival (P = 0.843)
Disease-free period (P = 0.096):
Tumor reappearance (P = 0.055):
|
RCT
Moderate quality evidence
|
|
Gorissen,
2013 [96]
|
Patients with obstructing left-sided colonic cancer
Preoperative SEMS (n = 62)
Emergency surgery (n = 43)
|
Median follow-up (P = 0.294)
Local recurrence rate (P = 0.443):
Distant metastasis (P = 1.000):
Overall recurrence (P = 0.824):
Overall mortality (P = 0.215):
Cancer-specific mortality (P = 0.180):
Local recurrence rate in patients ≤ 75 years (P = 0.038):
|
Prospective cohort study
Moderate quality evidence
|
|
Sabbagh,
2013 [97]
|
Patients operated on for left-sided malignant colonic obstruction with curative intent
Preoperative SEMS (n = 48)
Emergency surgery (n = 39)
|
Mean follow-up (P = 0.21):
5-year overall survival rate (P < 0.001):
5-year cancer-specific mortality (P = 0.02):
5-year disease-free survival (P = 0.24):
Overall recurrence rate (P = 0.18):
Mean time to recurrence (P = 0.92):
In multivariate analysis SEMS (HR 2.42, 95 %CI 1.13 – 5.18) and tumor perforation (HR 5.96, 95 %CI 1.70 – 20.95) were associated with overall survival
|
Retrospective intention-to-treat analysis
Low quality evidence
|
CI, confidence interval; HR, hazard ratio; IQR, interquartile range; RCT, randomized controlled trial.
1 Published in abstract form;
The oncological risks of SEMS should be balanced against the operative risks of emergency surgery. Because there is no reduction in postoperative mortality and stenting seems to impact on the oncological safety, the use of SEMS as a bridge to elective surgery is not recommended as a standard treatment for potentially curable patients with left-sided malignant colonic obstruction. However, placement of SEMS may be considered an alternative option in patients at high surgical risk. The known risk factors associated with adverse outcomes following elective as well as emergency surgery in colorectal cancer are increasing age and an ASA score ≥ III [3]
[17]
[18]
[19]
[98]
[99]. Therefore, the use of SEMS as a bridge to elective surgery may be considered an acceptable alternative treatment option in patients older than 70 years and/or with an ASA score ≥ III [100].
A time interval to operation of 5 – 10 days is suggested when SEMS is used as a bridge to elective surgery in patients with potentially curable left-sided colon cancer (weak recommendation, low quality evidence).
There are limited data to determine an optimal time interval to operation following stent placement as a bridge to surgery. Theoretically, a longer interval (> 1 week) will allow for better recovery and more nearly optimal nutritional status, but this may increase the risk of stent-related complications and may compromise surgery by more local tumor infiltration and fibrosis. Therefore we suggest a 5 – to 10-day interval between SEMS and elective resection. Data from the abstract of one RCT (n = 49) published in Chinese, which compared laparoscopic resection 3 and 10 days after stent placement, reported a significantly higher primary anastomosis rate and a lower conversion rate to open procedure when surgery was deferred until 10 days after stenting [101]. A retrospective analysis revealed an anastomotic leakage rate of 20 % (3/15) for an interval of 1 to 9 days and 0 % (0/28) when surgery was delayed for 10 days or longer (P = 0.037) [102]. A published abstract comparing resection within 7 days (n = 26) and after 7 days (n = 30) of stent placement, found no differences in the postoperative morbidity and mortality [103]. In the literature, a median time interval to surgery of 10 days is a common practice considering the patient’s clinical condition, potential risk of stent-related complications, and impact on oncological outcomes [84].
Clinical indication: palliative SEMS placement ([Table e4], available online)
Clinical indication: palliative SEMS placement ([Table e4], available online)
SEMS placement is the preferred treatment for palliation of malignant colonic obstruction (strong recommendation, high quality evidence).
Two meta-analyses, including randomized and nonrandomized comparative studies, have compared SEMS (n = 195 and n = 404) and surgery (n = 215 and n = 433) for palliation of malignant colonic obstruction ([Table 9]) [104]
[105]. The technical success of stent placement in the studies included ranged from 88 % to 100 % [6]
[106], while the initial clinical relief of obstruction was significantly higher after palliative surgery (100 %) compared with stent placement (93 %; P < 0.001) [104]
[105].
Both meta-analyses showed a lower 30-day mortality rate for SEMS, but it was significant only in the larger meta-analysis (4 % vs. 11 %, SEMS vs. surgery, respectively) [105]. Placement of a SEMS was significantly associated with a shorter hospitalization (10 vs. 19 days) and a lower intensive care unit (ICU) admission rate (0.8 % vs. 18.0 %) [104]
[105], while permitting a shorter time to initiation of chemotherapy (16 vs. 33 days) [105]
[107]. Surgical stoma formation was significantly lower after palliative SEMS compared with emergency surgery (13 % vs. 54 %) [105].
Table 9
Meta-analyses of palliative self-expandable metal stent (SEMS) placement.
|
First author, year
|
Study population
|
Results
|
Study type
Level of evidence
|
|
Liang,
2014 [104]
|
Patients with malignant colorectal obstruction caused by advanced malignancy
3 RCTs
2 Prospective
4 Retrospective
Palliative SEMS (n = 195)
Emergency surgery (n = 215)
|
Major stent-related complications:
-
Short-term (< 30 days) perforation rate: 3.7 %
-
Long-term (≥ 30 days) perforation rate: 7.6 %
-
Overall stent migration rate: 8.9 %
-
Re-obstruction: not analyzed.
Successful relief of obstruction:
-
Palliative SEMS: 94 %
-
Surgery: 100 %
Short-term (< 30 days) complication rate (P = 0.22):
Long-term (≥ 30 days) complication rate (P = 0.03):
Overall complication rate (P = 0.56):
Overall mortality rate (P = 0.22):
SEMS required significantly shorter hospitalization: weighted mean difference – 6.07 days (95 %CL – 8.40, – 3.74); P < 0.01
|
Systematic reviews and meta-analysis of comparative studies
High quality evidence
|
|
Zhao,
2013 [105]
|
Patients with malignant colorectal obstruction that was unresectable
3 RCTs
5 Prospective
4 Retrospective
1 Case-matched
Palliative SEMS (n = 404)
Palliative surgery (n = 433)
|
Mean length of hospital stay (P < 0.001):
ICU admission rate (P = 0.001):
Mean interval to chemotherapy:
Clinical relief of obstruction (P < 0.001):
-
Palliative SEMS: 93.1 % (375/403)
-
Surgery: 99.8 % (433/434)
-
RR 0.96 (95 %CI 0.93 – 0.98); I
2 = 3 %
In-hospital mortality rate (P = 0.01):
Overall complication rate (P = 0.60):
-
Palliative SEMS: 34.0 % (137/403)
-
Surgery: 38.1 % (172/452)
-
RR 0.91 (95 %CI 0.64 – 1.29); I
2 = 66 %
Early complication rate (P = 0.03):
-
Palliative SEMS: 13.7 % (41/300)
-
Surgery: 33.7 % (110/326)
-
RR 0.45 (95 %CI 0.22 – 0.92); I
2 = 66 %
Late complication rate (P < 0.001):
Stent complications:
Overall survival time (P = n.s.):
Stoma formation rate (P < 0.001):
-
Palliative SEMS: 12.7 % (38/299)
-
Surgery: 54.0 % (170/315)
-
RR 0.26 (95 %CI 0.18 – 0.37); I
2 = 18 %
|
Systematic review and meta-analysis of comparative studies
High quality evidence
|
CI, confidence interval; CL, confidence limits; ICU, intensive care unit; n.s., not significant; OR, odds ratio; RCT, randomized controlled trial; RR, risk ratio.
The larger meta-analysis showed no significant difference in overall morbidity between the stent group (34 %) and the surgery group (38 %) [105]. Short-term complications did occur more often in the palliative surgery group, while late complications were more frequent in the SEMS group. Stent-related complications mainly included colonic perforation (10 %), stent migration (9 %) and re-obstruction (18 %) [105].
The aforementioned results are supported by other recently published literature, including one RCT that was not included in the meta-analyses [11]
[55]
[108]
[109]
[110]
[111]
[112]
[113]
[114].
There are insufficient data regarding the outcome of stent placement in patients with peritoneal carcinomatosis ([Table e1], available online). One large retrospective study showed a significantly lower technical success rate in patients with carcinomatosis compared with patients without carcinomatosis (83 % vs. 93 %) [8]. Another series, that focused on the outcomes of secondary SEMS insertion after initial stent failure, reported a significantly decreased stent patency in the setting of carcinomatosis (118 days vs. 361 days) [115]. Despite the lower probability of success, SEMS placement may be an alternative to surgical decompression in the setting of peritoneal carcinomatosis. However, there is a lack of evidence to underpin a definite recommendation on this topic.
Patients who have undergone palliative stenting can be safely treated with chemotherapy without antiangiogenic agents (strong recommendation, low quality evidence). Given the high risk of colonic perforation, it is not recommended to use SEMS as palliative decompression if a patient is being treated or considered for treatment with antiangiogenic therapy (e. g. bevacizumab) (strong recommendation, low quality evidence).
It has been speculated that chemotherapy during stenting might induce stent-related complications, in particular perforation. Several retrospective series reported an increased risk of stent perforation (17 % – 50 %) in patients treated with bevacizumab, an angiogenesis inhibitor [15]
[55]
[116]. A meta-analysis, searching for risk factors of stent perforation in a heterogeneous population, found a significantly increased perforation rate in patients receiving bevacizumab (12.5 %) compared with patients who received no concomitant therapy during colorectal stenting (9.0 %), while chemotherapy without bevacizumab was not associated with an increased risk of stent perforation (7.0 %) [51]. Despite the lack of evidence, an increased perforation risk can reasonably be extrapolated to the newer antiangiogenic agents, aflibercept and regorafenib, because of the similar therapeutic mechanism. Therefore, SEMS placement is strongly discouraged for patients who are being treated or considered for further treatment with antiangiogenic drugs.
Low quality published evidence showed contradictory results regarding the outcome of stenting during chemotherapy [8]
[11]
[117]. Nevertheless, no clear increase in adverse events has been observed with colonic stenting. Palliative chemotherapy in patients with a colonic stent is associated with prolonged survival [76]
[118], and might therefore result in more patients being exposed to the risk of late stent complications. Suspicion of an association between chemotherapy and the occurrence of stent migration due to tumor shrinkage is prompted by several retrospective series [43]
[119]
[120].
Long-term stent complications are not automatically an argument in favor of palliative surgery. The lower short-term mortality and the early start of chemotherapy because of SEMS should not be disregarded.
Adverse events related to colonic stenting ([Table e5], available online)
Adverse events related to colonic stenting ([Table e5], available online)
When stent obstruction or migration occurs in the palliative setting, endoscopic re-intervention by stent-in-stent placement or SEMS replacement is suggested (weak recommendation, low quality evidence). Surgery should always be considered in patients with stent-related perforation (strong recommendation, low quality evidence).
Colonic SEMS placement in patients with malignant large-bowel obstruction is associated with potential adverse events. However, the 30-day stent-related mortality rate is less than 4 % [11]
[12]
[105]. Median stent patency in the palliative setting ranges widely between 55 days and 343 days [58]
[59]. One systematic review published in 2007 found a median stent patency of 106 days (range 68 – 288 days) in the palliative stent population [121]. Around 80 % (range 53 % – 90 %) of patients maintain stent patency until death or end of follow-up [48]
[55]
[109]
[113]
[117]
[122]. In the bridge-to-surgery setting, stent patency is maintained until surgery in the large majority of patients.
Adverse events related to colonic stent placement are usually divided into early (≤ 30 days) and late (> 30 days). The main early complications are perforation (range 0 % – 12.8 %), stent failure after technically successful stent deployment (range 0 % – 11.7 %), stent migration (range 0 % – 4.9 %), re-obstruction (range 0 % – 4.9 %), pain (range 0 % – 7.4 %), and bleeding (range 0 % – 3.7 %) [8]
[12]
[31]
[109]. Late adverse events related to SEMS mainly include re-obstruction (range 4.0 % – 22.9 %) and stent migration (range 1.0 % – 12.5 %), and more rarely perforation (range 0 % – 4.0 %) [8]
[11]
[105]
[109]
[113]
[117]
[122], although one RCT reported late perforations in 4 out of 10 stent patients [123]. Other SEMS complications reported less frequently in the literature are tenesmus (up to 22 %, related to rectal SEMS), incontinence, and fistula [16]
[109]
[112]
[122].
Stent-related perforation may result from different causes which can be classified as proposed by Baron et al.: (i) guidewire or catheter malpositioning; (ii) dilation of the stricture before or after stent placement; (iii) stent-induced perforation (tumor and nontumor local perforation); and (iv) proximal colonic distension because of inadequate colonic decompression or excessive air insufflation [57]. The final outcome of stent perforation has been inconsistently reported in the literature, although a perforation-related mortality rate of 50 % is observed in a number of prospective and retrospective studies [11]
[55]
[120]
[123]. Furthermore, there are strong indications that perforation compromises the oncological outcome in patients with colorectal cancer [95]
[97]
[124]. Concurrent bevacizumab therapy, intraprocedural and post-stenting stricture dilation, and diverticular strictures were identified by several studies as risk factors for stent-related perforation [12]
[15]
[33]
[47]
[51]
[55].
Stent migration can occur at any time following colonic stenting. Factors that have been identified to correlate with the occurrence of migration are use of covered SEMS and of small-diameter (< 24 mm) stents [15]
[52]
[54]
[55], and there is some evidence that chemotherapy may also be associated with stent migration by the mechanism of tumor shrinkage [43]
[119]
[120].
Tumor ingrowth/overgrowth is the main cause of stent re-obstruction and usually occurs during the long-term course of stent therapy. The use of uncovered SEMS is a risk factor for tumor ingrowth [52]. One retrospective series focusing on predictive factors of stent occlusion found that < 70 % stent expansion within the first 48 hours is also predictive for the occurrence of re-obstruction [125].
Both migration and re-obstruction can be managed endoscopically. Stent replacement and stent reopening by a stent-in-stent have been reported as first choice in the majority of papers, with satisfactory results (clinical success 75 % – 86 %) [114]
[115], even though the long-term outcome of second stenting or other endoscopic maneuvers is rarely and poorly reported [11]
[15]
[48]
[76]
[109]
[110]
[112].
ESGE guidelines represent a consensus of best practice based on the available evidence at the time of preparation. They may not apply in all situations and should be interpreted in the light of specific clinical situations and resource availability. Further controlled clinical studies may be needed to clarify aspects of these statements, and revision may be necessary as new data appear. Clinical consideration may justify a course of action at variance to these recommendations. ESGE guidelines are intended to be an educational device to provide information that may assist endoscopists in providing care to patients. They are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment.
Appendix e1 Self-expandable metal stents (SEMSs) for obstructing colonic and extracolonic cancer: key questions and task force subgroups.
Appendix e1 Self-expandable metal stents (SEMSs) for obstructing colonic and extracolonic cancer: key questions and task force subgroups.
Appendix e1
|
Topics and key questions
|
Task forces
(leads in bold)
|
|
1. The stent placement procedure: general considerations
|
|
|
1a What are the radiographic, endoscopic, and clinical criteria of a colorectal obstruction suitable for stent placement?
|
Regina Beets-Tan
Fergal Donnellan
Gianpiero Manes
Michael Parker
Jo Vandervoort
|
|
1b Pathological confirmation required?
-
Is there a difference in safety and efficacy between colorectal stent placement in malignant versus benign strictures?
-
How many patients presenting with acute colorectal obstruction have a benign disease?
-
How to diagnose a malignancy in patients presenting with acute colorectal obstruction?
|
|
1c Patient characteristics
-
Is stent placement in the elderly associated with a worse outcome? Is there a difference in outcome between a palliative or curative intent in the elderly?
-
Does patient’s performance status (WHO) influence the outcome of stent therapy? Is there a difference in outcome between a palliative or curative intent with regard to performance status?
|
|
1 d Preferred preparation?
-
What is the optimal workup of patients undergoing colorectal stent placement: radiographic imaging, bowel preparation?
-
Is antiobiotic prophylaxis indicated? In other words, what is the risk of post-procedural infections?
|
|
1e By whom?
-
Is there a difference in technical and clinical success rate between purely fluoroscopic, purely endoscopic, or combined stent placement?
-
Does operator experience influence the success rate of stent placement? If relevant, what should be the level of experience of an operator for performing colorectal stent placement?
-
Can the effect of a learning curve be observed in terms of a better technical and clinical outcome of stent placement?
-
Should a training be followed before an operator is allowed to perform colorectal stent placement? What should this training look like?
|
Regina Beets-Tan
Fergal Donnellan
Gianpiero Manes
Michael Parker
Alessandro Repici
|
|
1f Patient monitoring?
|
|
1 g Synchronous strictures?
-
What is the incidence of a synchronous, second stricture which causes the primary stent placement to be ineffective?
-
How to check for synchronous lesions?
|
|
2. The stent placement procedure: technical considerations
|
|
|
2a Stent choice?
-
Is there a difference in technical and clinical success rate between stent placement over the wire or through the scope?
-
How to determine optimal stent length and diameter?
-
Are there stents specifically designed for certain characteristics of the stenosis: tortuous anatomy, proximal colon?
-
Is there a difference in technical and clinical outcome between the use of covered vs. uncovered stents?
-
Is there a difference in outcome (safety and efficacy) between the available stent designs?
|
Marc Barthet
Gianpiero Manes
Søren Meisner
Geoffroy Vanbiervliet
George Webster
|
|
2b Stricture dilation?
|
|
2c Stricture characteristics
-
Is there a difference in safety and efficacy between colorectal stent placement in malignant versus benign strictures?
-
Is there a difference in outcome (safety and efficacy) between stenting the right versus left colon?
-
Does an extracolonic malignancy influence the outcome (safety and efficacy) of stent placement?
-
Does stricture length influence the technical and clinical outcome of stent placement?
-
Is stenting of incomplete strictures as effective as stenting complete obstructions?
|
Marc Barthet
Gianpiero Manes
Søren Meisner
Jean-Marc Regimbeau
Charles Sabbagh
Geoffroy Vanbiervliet
|
|
3. Clinical indications
|
|
|
3a Does stent placement followed by elective surgery (stent as bridge to surgery) improve clinical outcome measurements compared with emergency surgery:
-
clinical and technical success?
-
morbidity (including anastomotic leaks, wound infections) and mortality?
-
survival?
-
hospital stay?
-
one-stage surgery/stoma rate?
-
quality of life?
-
costs?
-
What should be the interval between stent placement and resection regarding patient’s clinical condition or oncological outcome?
-
Are there advantages for a subgroup of patients, e. g. poor performance status, high age?
|
Robert Glynne-Jones
Javier Jiménez-Pérez
Gianpiero Manes
Jayesh Sagar
Pieter Tanis
|
|
3b Does colonic stenting in palliation of malignant colonic obstruction improve clinical outcome measurements compared with palliative surgery:
-
clinical and technical success?
-
morbidity (including anastomotic leaks, wound infections) and mortality?
-
survival?
-
hospital stay?
-
one-stage surgery/stoma rate?
-
quality of life?
-
costs?
-
Are there advantages for a subgroup of patients, e. g. poor performance status, high age?
|
Marc Barthet
Robert Glynne-Jones
Michael Parker
Jayesh Sagar
Geoffroy Vanbiervliet
Jo Vandervoort
|
|
4. Oncological perspective
|
Robert Glynne-Jones
Jean-Marc Regimbeau
Charles Sabbagh
Pieter Tanis
Jo Vandervoort
George Webster
|
|
4a Do stents influence the oncological outcome (local recurrence rate, metastatic disease) in a curative setting?
|
|
4b Does stent perforation influence the oncological outcome (local recurrence rate, metastatic disease)?
-
Are these consequences different for guidewire perforations, clinical perforations during stent placement, clinical perforations after stent placement, and occult perforations?
|
|
4c What is the safety of chemotherapy during stent therapy?
|
|
4 d What is the safety of bevacizumab-based chemotherapy during stent therapy?
|
|
5. Adverse events related to colonic stenting
|
Fergal Donnellan
Jean-Marc Regimbeau
Alessandro Repici
Charles Sabbagh
George Webster
|
|
5a What are the adverse events related to colorectal stenting and what is their incidence?
|
|
5b What is the mean/median stent patency?
|
|
5c How should adverse events (migration, occlusion, malfunction, perforation) be treated?
|
|
5 d What factors influence the occurrence of adverse events?
|
WHO, World Health Organization
Appendix e2 Evidence tables. Self-expanding metal stents (SEMSs) for obstructing colonic and extracolonic cancer: European Society of Gastrointestinal Endoscopy (ESGE) Guideline
Appendix e2 Evidence tables. Self-expanding metal stents (SEMSs) for obstructing colonic and extracolonic cancer: European Society of Gastrointestinal Endoscopy (ESGE) Guideline
Table e1 a (a – h)
General considerations before stent placement. (a) Outcomes of SEMS placement in patients with peritoneal carcinomatosis and in the rectum.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Choi,
2013 [13]
|
Retrospective
|
Colorectal SEMS placement
Niti-S,
Hanarostent,
Choostent,
Bonastent
Covered 27 %
Uncovered 73 %
|
Patients with malignant colorectal obstruction (n = 152)
|
Clinical effectiveness, complications, and risk factors associated with the complications of SEMS placement
|
Univariate analysis of risk factors for complications:
Multivariate analysis of risk factors for complications:
|
Low
|
|
Kim JH,
2013 [9]
|
Retrospective
|
Palliative SEMS placement
Comvi stent,
Niti-S stent
|
Patients with malignant colorectal obstruction by a noncolonic malignancy with peritoneal carcinomatosis (n = 20)
|
Survival and long-term clinical outcome of SEMS
|
Technical success rate: 90 %
Clinical success rate: 85 %
Overall clinical success: 50 %
Surgical intervention: 45 %
Mean event-free survival: 119 days
Overall survival: 156 days
|
Low
|
|
Yoon,
2011 [8]
|
Retrospective
|
Colorectal SEMS insertion
Niti-S covered,
Comvi stent,
WallFlex,
Niti-S D-type
|
Patients with malignant colorectal obstruction (n = 412)
|
Rates and factors predictive of technical and clinical failure of SEMS
|
Technical success rate for:
-
Carcinomatosis, no vs. yes: 93 % vs. 83 % (OR 2.83; P = 0.019)
-
Age, < 70 vs. ≥ 70 years: 86 % vs. 89.2 % (P = 0.477)
Immediate clinical success rate for:
-
Carcinomatosis, no vs. yes: 84.5 % vs. 83.2 % (P = 0.986)
-
Age, < 60 vs. ≥ 60 years: 83 % vs. 84.3 % (P = 0.790)
|
Low
|
|
Yoon,
2011 [115]
|
Retrospective
|
Secondary SEMS placement as stent-in-stent
Niti-S covered,
Comvi covered,
WallFlex uncovered,
Niti-S D-type uncovered
|
Patients who underwent secondary SEMS because of the recurrence of obstructive symptoms (n = 36)
|
Immediate and long-term clinical success and complications
|
Immediate clinical success rate for:
Median duration of stent patency for:
Predictive factors for complications:
|
Low
|
|
Song,
2008 [10]
|
Retrospective
|
SEMS placement
Fully covered Stentech,
Fully covered Taewoong,
Dual stent
|
Patients with malignant rectal obstruction
|
Technical feasibility, clinical effectiveness and safety of SEMS
|
Overall technical success rate: 100 %
Complications of SEMS < 5 cm vs. > 5 cm of the anal verge:
-
Pain: 63 % vs. 14 % (P = 0.011)
-
Incontinence: 13 % vs. 0 % (P = 0.485)
-
Migration: 6 % vs. 21 % (P = 0.315)
-
Incomplete stent expansion: 13 % vs. 7 % (P = 1.0)
-
Perforation: 6 % vs. 7 % (P = 1.0)
-
Tumor ingrowth: 0 % vs. 7 % (P = 0.467)
-
Hematochezia: 6 % vs. 0 % (P = 1.0)
Multivariate analysis:
|
Low
|
Table e1 b (a – h)
General considerations before stent placement. (b) Outcome of SEMS placement according to age and American Society of Anesthesiologists (ASA) classification.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Abbott,
2014 [11]
|
Retrospective
|
Palliative endoscopic SEMS insertion
Wallstent,
Taewoong,
Schneider
|
Patients with colonic obstruction due to colorectal cancer or metastatic extracolonic disease (n = 146)
|
Technical success and complication rates of SEMS, and identifying any predictors of stent-related complications and re-intervention
|
Technical success rate: 97.3 %
Clinical success rate: 95.8 %
Overall complication rate: 39.7 %
Overall re-intervention rate: 30.8 %
-
Endoscopic: 18.5 %
-
Surgical: 14.4 %
Predictors of early complications:
Predictors of late complications:
Predictors of endoscopic re-intervention:
Predictors of surgical treatment:
|
Low
|
|
Geraghty,
2014 [16]
|
Retrospective
|
Colonic stenting for large-bowel obstruction
|
Patients in whom SEMS placement was attempted for large-bowel obstruction (n = 334)
|
Outcome of colonic stenting and factors associated with successful intervention
|
Factors related to technical success:
Factors related to clinical success:
|
Low
|
|
Choi,
2013 [13]
|
Retrospective
|
Colorectal SEMS placement
Niti-S
Hanarostent
Choostent
Bonastent
Covered 27 %
Uncovered 73 %
|
Patients with malignant colorectal obstruction (n = 152)
|
Clinical effectiveness, complications and risk factors associated with the complications of SEMS placement
|
Univariate analysis of risk factors for complications:
-
Mean age for complications vs. no complications: 66 vs. 70 years (P = 0.235)
-
Complication rate for ASA I, II and III: 24.2 %, 34.3 % and 34.8 %, respectively (P = 0.556)
|
Low
|
|
Meisner,
2011 [12]
|
Prospective cohort
|
WallFlex Colonic stent placement
|
Patients with malignant colonic obstruction (n = 463)
-
Palliative SEMS placement (n = 255)
-
SEMS as bridge to surgery (n = 182)
-
Indication not specified (n = 10)
|
Performance, safety and effectiveness of colorectal stents
|
Procedural success rate for ASA I – II vs. ASA ≥ III: 98.1 % vs. 98.1 % (P = 1.000)
30-day clinical success rate for ASA I – II vs. ASA ≥ III: 92.1 % vs. 87.4 % (P = 0.162)
Overall complication rate for ASA I – II vs. ASA ≥ III: 11.4 % vs. 11.5 % (P = 0.987)
|
Moderate
|
|
Donnellan,
2010 [14]
|
Retrospective
|
Uncovered Wallstent insertion
|
Patients with malignant colorectal obstruction
-
≥ 70 years (n = 24)
-
< 70 years (n = 19)
|
Success rate, complications and mortality of SEMS insertion
|
Older versus younger group
-
Successful stent placement: 88 % vs. 100 % (P = n.s.)
-
Overall complications: 12.5 % vs. 26 % (P = n.s.)
-
30-day mortality: 22 % vs. 13 % (P = n.s.)
-
Median survival: 112.5 vs. 134.5 days (P = 0.09)
|
Low
|
|
Small,
2010 [15]
|
Retrospective
|
Colonic SEMS placement
Ultraflex,
Wallstent,
WallFlex
|
Patients with malignant colorectal obstruction (n = 233)
|
Long-term efficacy, incidence of complications, and risk factors of SEMS placement
|
Major complication rate for age ≤ 65 vs. > 65 years: 25.9 % vs. 22.2 % (P = 0.259)
|
Low
|
Table e1 c (a – h)
General considerations before stent placement. (c) Computed tomography (CT) scan for the diagnosis of colonic obstruction.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Frager,
1998 [20]
|
Prospective
|
CT scan with oral contrast;
Dynamic/spiral technique (n = 40)
Intravenous contrast (n = 56)
Rectal air insufflation (n = 2)
|
Patients with suspected colonic obstruction (n = 75)
Outcomes of CT were compared with:
|
Diagnostic capabilities and limitations of CT in diagnosing colonic obstruction
|
Sensitivity: 96 % (45/47)
Specificity: 93 % (26/28)
Correct pathologic diagnosis: 81 % (38/47)
Correct localization of obstruction: 94 % (44/47)
CT was more sensitive (P = 0.045), more accurate (P = 0.047), and had a better negative predictive value (P = 0.0004) than contrast enema
|
Low
|
Table e1 d (a – h)
General considerations before stent placement. (d) Preoperative detection of synchronous colorectal cancer.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Lim,
2013 [27]
|
Prospective
|
Preoperative colonoscopy after SEMS insertion in patients with a resectable cancer
Bonastent covered,
Niti-S uncovered
|
Patients with malignant colorectal obstruction (n = 73)
SEMS as bridge to surgery (n = 45)
|
Success rate of complete colonoscopy after stent placement
|
Complete preoperative colonoscopy: 88.9 % (40/45)
Complete colonoscopy for uncovered vs. covered SEMS: 96 % vs. 80 % (P = 0.154)
The colonoscope was not damaged mechanically by passage through the stent
Bowel preparation:
-
Excellent 17.8 %
-
Good 55.5 %
-
Fair 26.7 %
Synchronous lesions:
Stent migration due to:
|
Low
|
|
Park SH,
2012 [25]
|
Retrospective
|
CT colonography (CTC) with intravenous contrast after failed colonoscopy of the proximal colon past a newly diagnosed advanced colorectal cancer
|
Patients with advanced colorectal cancer without an acutely severe colonic obstruction requiring immediate colonic decompression (n = 411)
Pathological specimen and/or postoperative colonoscopy with pathological confirmation of proximal lesions as reference (n = 284)
|
Performance measures of CTC for detecting and characterizing synchronous lesions proximal to a stenosing colorectal cancer
|
Patients with positive findings on CTC (lesion ≥ 6 mm in proximal colon): 31.7 %
Per-patient sensitivity for detection in the proximal colon:
Per-patient negative predictive value (NPV)
Per-lesion sensitivity for detecting cancer 100 % (8/8)
CTC missed:
-
Advanced adenomas 22.8 % (13/57)
-
Non-advanced adenomas 34.2 % (25/73)
-
Non-neoplastic lesions 57.1 % (8/14)
False-positive lesions found by CTC: 32.5 % (51/157)
Per-lesion positive predictive value (PPV) for all histological types of lesion: 67.5 % (106/157)
Per-lesion, for cancer with lesion size criterion of ≥ 15 mm on CTC:
-
Sensitivity 87.5 % (7/8)
-
PPV 70 % (7/10)
|
Moderate
|
|
Cha,
2010 [26]
|
Retrospective
|
CT colonography (CTC) after SEMS placement
Hercules SP colorectal stent,
Niti-S D-type,
WallFlex,
Comvi stent,
Bonastent
|
Patients successfully treated with SEMS placement for acute colon obstruction caused by pathologically proven colorectal cancer (n = 50)
Surgical specimen findings and/or postoperative colonoscopy as a reference standard (n = 31)
|
Diagnostic performance of CTC for preoperative examination of the proximal colon after metallic stent placement
|
Examination quality inadequate: 6 %
14 lesions ≥ 6 mm were found proximal to the stent in 10 patients
Synchronous lesions:
Per-lesion sensitivity for lesions ≥ 6 mm proximal to stent: 85.7 % (12/14)
CTC detection of synchronous lesions:
CTC missed two sessile tubular adenomas
Per-patient sensitivity for lesions ≥ 6 mm: 90 % (9/10)
Per-patient specificity for lesions ≥ 6 mm: 85.7 % (18/21); false positive findings n = 3
CTC did not generate any false diagnosis of synchronous cancer
No perforation or stent migration was noted in any of the 50 patients
|
Low
|
|
Vitale,
2006 [28]
|
Prospective
|
Preoperative colonoscopy after effective stent placement
Enteral Wallstent,
Ultraflex Precision
|
Patients with acute neoplastic colon obstruction (n = 57)
SEMS as bridge to surgery (n = 31)
|
Feasibility of a preoperative colonoscopy after stent placement
|
Complete colonoscopy in resectable patients: 93.5 % (29/31)
Complications related to colonoscopy:
No endoscope mechanical damage was detected
Bowel preparation:
-
Excellent: 35.5 %
-
Good: 48.4 %
-
Fair: 16.1 %
Results of preoperative colonoscopy:
|
Low
|
Table e1 e (a – h)
General considerations before stent placement. (e) Stenting for benign colorectal obstruction.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Currie,
2014 [33]
|
Systematic review
|
Endoscopic or fluoroscopic placement of a self-expanding stent
|
Patients with benign colorectal obstruction (n = 122)
21 case series
Diverticulitis 54 %
Anastomotic stricture 33 %
|
Efficacy and safety of self-expandable stents
|
Overall success rate:
-
Technical 94 %
-
Clinical 80 %
Perforation rate: 12 %
Re-obstruction rate 14 %
-
Stent collapse (n = 10)
-
Stool impaction (n = 5)
Stent migration rate: 20 %
Diverticulitis patients:
-
Bridge to surgery: 61 %
-
Stoma avoidance: 42 %
-
Complications: 52 %
|
Moderate
|
Table e1 f (a – h)
General considerations before stent placement. (f) Brush cytology and biopsy for the diagnosis of colorectal cancer.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Brouwer,
2009 [34]
|
Retrospective
|
Brush cytology, endoscopic biopsy, and definitive resection of the colorectal lesion
|
Patients who had both cytology and biopsy of a colorectal lesion that was then resected and submitted to formal histologic analysis (n = 918)
|
Results of brush cytology for the diagnosis of colorectal cancer
|
Brush cytology versus biopsy:
-
Sensitivity: 88.2 % vs. 86.9 % (P = 0.485)
-
Specificity: 94.1 % vs. 98.1 % (P = 0.065)
-
PPV: 98.6 % vs. 99.5 % (P = 0.159)
-
NPV: 61.9 % vs. 60.3 % (P = 0.797)
-
False-positive rate: 0.06 % vs. 0.02 % (P = 0.160)
-
False-negative rate: 0.12 % vs. 0.13 % (P = 0.543)
Histology versus combined cytology/biopsy:
-
Sensitivity: 86.9 % vs. 97.4 % (P < 0.001)
-
Specificity: 98.1 % vs. 98.7 % (P = 1.000)
-
PPV: 99.5 % vs. 99.7 % (P = 0.900)
-
NPV: 60.3 % vs. 88.4 % (P < 0.001)
-
False-positive rate: 0.02 % vs. 0.01 % (P = 1.000)
-
False-negative rate: 0.13 % vs. 0.03 % (P < 0.001)
|
Moderate
|
|
Geramizadeh,
2003 [35]
[1]
|
Description of design missing
|
Brush cytology and biopsy at the same time
|
Patients with any colorectal lesion on colonoscopy (n = 72)
|
Specificity and sensitivity of brush cytology and biopsy
|
Sensitivity and specificity:
Brush cytology: 88 % and 98 %
Biopsy: 96 % and 100 %
Combined cytology and biopsy: sensitivity 100 %
|
Low
|
|
Farouk,
1996 [36]
|
Prospective
|
Brush biopsy with a cervical smear brush followed by conventional forceps biopsy
|
Patients seen at rectal outpatient clinic with rectal lesions suspicious of carcinoma (n = 289)
Subsequent surgical resection (n = 249)
|
Assessment of brush cytology as an aid for the diagnosis of rectal cancer
|
Biopsy versus brush cytology:
-
True-positive: 88.1 % vs. 90.6 %
-
True-negative: 100 % vs. 97.8 %
-
False-positive: 0 % vs. 0.3 %
-
False-negative: 13.9 % vs. 9.4 %
-
Sensitivity: 81 % vs. 83 % (combined 98 %)
-
Specificity: 100 % vs. 90 %
|
Moderate
|
1 Data extracted from abstract because of no access to the journal.
Table e1 g (a – h)
General considerations before stent placement. (g) Risk of bacteremia following colorectal stent placement.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Chun,
2012 [37]
|
Prospective
|
Colorectal stent placement
Hanarostent,
Bonastent
|
Patients who underwent colorectal stent insertion (n = 125)
Patients analyzed (n = 64)
|
Risk of bacteremia and infectious complications within 48 h after stent insertion
|
Blood cultures at baseline: all negative
Post-procedural positive blood cultures: 6.3 %
Considered contaminants: 3.1 %
None of the study subjects developed fever in the 48 h after stent placement
Median time required for stent placement in patients with transient bacteremia vs. negative blood cultures: 35.5 vs. 16.0 min (P = 0.006)
|
Moderate
|
|
Small,
2010 [15]
|
Retrospective
|
Colonic SEMS placement
Ultraflex,
Wallstent,
WallFlex
|
Patients with malignant colorectal obstruction (n = 233)
|
Long-term efficacy, incidence of complications, and risk factors of SEMS placement
|
Blood cultures drawn ≤ 2 weeks after stent placement: 13 % (30/224)
Positive cultures: 3 % (7/224)
-
Escherichia coli (n = 4)
-
Bacteroides fragilis (n = 1)
-
Clostridium sordellii (n = 1)
-
Staphylococcus aureus (n = 2)
Bacteremia incidence for degree of obstruction (P = 0.38):
Minor complications:
|
Low
|
Table e1 h (a – h)
General considerations before stent placement. (h) Operator experience in colorectal stenting.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Geraghty,
2014 [16]
|
Retrospective
|
Colonic stenting for large-bowel obstruction
|
Patients in whom SEMS placement was attempted for large-bowel obstruction (n = 334)
|
Outcome of colonic stenting and factors associated with successful intervention
|
Multivariate analysis of factors related to technical success:
Multivariate analysis of factors related to clinical success:
|
Low
|
|
Lee JH,
2012 [39]
|
Retrospective
|
SEMS insertion by one experienced colonoscopist with no experience in ERCP
Niti-S covered,
Comvi stent,
WallFlex,
Niti-S D-type
|
Patients with malignant colorectal obstruction (n = 120)
|
Assessment of the effectiveness of SEMS insertion by evaluating the learning curve an endoscopist
|
Outcomes from first to last quartile
Technical success rate: 90.0 %, 96.7 %, 96.7 %, and 96.7 % (P = 0.263)
Clinical success rate: 90.0 %, 90.0 %, 96.7 %, and 83.3 % (P = 0.588)
Complication rate: 26.7 %, 23.3 %, 10.0 %, and 33.3 % (P = 0.184)
Number of stents per procedure: 1.13, 1.03, 1.00, and 1.00 (P = 0.029)
Median procedure duration significantly decreased from 20.9 to 14.8 minutes after the first 30 procedures (P = 0.005)
|
Low
|
|
Williams,
2011 [38]
|
Prospective
|
SEMS placement performed by a single surgeon endoscopist and a consultant radiographer
|
Patients with acute or subacute large-bowel obstruction (n = 37)
|
Change in practice over time and the learning curve of a single surgeon endoscopist
|
Chronological outcome of stenting procedures:
Technical success rate:
-
Procedure 1 – 11: 82 %
-
Procedure 12 – 21: 90 %
-
Procedure 22 – 37: 94 %
Number of stents per procedure:
-
Procedure 1 – 11: 1.7 stents
-
Procedure 12 – 21: 1.1 stents
-
Procedure 22 – 37: 1.0 stents
|
Low
|
|
Small,
2010 [15]
|
Retrospective
|
Colonic SEMS placement
Ultraflex,
Wallstent,
WallFlex
|
Patients with malignant colorectal obstruction (n = 233)
|
Long-term efficacy, incidence of complications, and risk factors of SEMS placement
|
Major complication rate for ERCPist vs. non-ERCPist: 21.0 % vs. 33.3 % (P = 0.030)
Immediate perforation rate for ERCPist vs. non-ERCPist: 1.7 % (3/176) vs. 7.0 % (4/57) (P = 0.021)
|
Low
|
ASA, American Society of Anesthesiologists; CRC, colorectal cancer; CTC, CT colonography; CI, confidence interval; ERCP, endoscopic retrograde cholangiopancreatography; n.s,, not significant; NPV, negative predictive value; PPV, positive predictive value; OR, odds ratio; SEMS, self-expandable metal stent.
Table e2 a (a – i)
Technical considerations of stent placement. (a) Method of self-expandable metal stent (SEMS) placement.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Geraghty,
2014 [16]
|
Retrospective
|
Radiologic over-the-wire (OTW) or endoscopic through-the-scope (TTS) colonic stent placement
|
Patients in whom SEMS placement was attempted for large-bowel obstruction (n = 334)
|
Outcome of colonic stenting and factors associated with successful intervention
|
Overall success rate:
-
Technical 87.4 %
-
Clinical 83.5 %
Multivariate analysis of factors related to technical success:
Multivariate analysis of factors related to clinical success:
|
Low
|
|
Kim JW,
2013 [46]
|
Retrospective
|
Colorectal SEMS placement
Niti-S D-type uncovered
Niti-S covered
Covered Comvi stent
|
Patients with malignant colorectal obstruction
Combined endoscopic and fluoroscopic TTS stent placement (n = 73)
Radiologic OTW stent placement (n = 38)
|
Clinical outcomes of endoscopic and radiologic SEMS placement
|
Endoscopic versus radiologic stent placement
-
Technical success rate: 100 % vs. 92.1 % (P = 0.038)
-
Clinical success rate: 91.8 % vs. 97.1 % (P = 0.424)
-
Complication rate: 32.4 % vs. 15.4 % (P = 0.303)
-
Median stent patency: 70 days vs. 93 days (P = 0.428)
|
Low
|
|
de Gregorio,
2011 [48]
|
Retrospective
|
Colorectal stent placement
Wallstent
SX-ELLA intestinal stent
|
Patients with total or partial large-bowel obstruction secondary to malignancy
Fluoroscopic OTW stent placement (n = 401)
Combined endoscopic and fluoroscopic OTW stent placement (n = 66)
|
Radiation dose of fluoroscopic and combined endoscopic and fluoroscopic stent placement
|
Radiologic versus endoscopic stent placement
Procedure time: 67.1 vs. 65.5 min (P = 0.541)
Radiation dose: 3,439 vs. 3,010 dGy·cm2 (P < 0.001)
Technical success rate: 92.8 % vs. 90.9 % (P = 0.595)
Clinical success rate: 90.5 % vs. 74.2 % (P < 0.001)
Complication rate: 21.7 % vs. 18.2 % (P = 0.517)
|
Low
|
|
Selinger,
2011 [45]
|
Retrospective
|
Radiologic colonic stent insertion
Hanarostent
Wallstent
Choo stent
Niti-S
Others
|
Patients who underwent colonic SEMS insertion (n = 96)
|
Factors associated with technical and clinical outcomes of SEMS placement
|
Technical success rate 83.3 %
Clinical success rate 77.1 %
Early complications:
-
Death 2.5 %
-
Stent migration 3.8 %
-
Severe bleeding 2.5 %
-
Perforation 1.3 %
-
Stent obstruction 1.3 %
|
Low
|
|
Kim SY,
2010 [40]
|
Retrospective
|
Radiologic uncovered SEMS placement
Hanarostent
EGIS stent
|
Patients with malignant colorectal obstruction (n = 99)
|
Effectiveness of radiologic uncovered stent placement
|
Overall success rate:
-
Technical 94.8 %
-
Clinical 89.1 %
There were no procedure-related major complications such as major bleeding or colonic perforation
|
Low
|
|
Kim JH,
2009 [43]
|
Prospective
|
Radiologic dual-design SEMS insertion
Flared ends (n = 69)
Bent ends (n = 53)
|
Patients with malignant colorectal obstruction (n = 122)
|
Clinical safety and efficacy of dual-design stents
|
Flared-ends versus bent-ends
-
Technical success rate: 94.2 % vs. 96.2 %
-
Clinical success rate: 93.8 % vs. 90.2 %
-
Overall complication rate: 18.5 % vs. 25.5 %
-
Perforation rate: 6.2 % vs. 5.9 %
-
Stent migration rate: 6.2 % vs. 5.9 %
|
Moderate
|
|
Kim H,
2008 [41]
|
Retrospective
|
Fluoroscopically guided colorectal stent insertion without endoscopic assistance
Hanarostent
Dual stent
|
Patients with acute malignant colorectal obstruction (n = 42)
|
Technical feasibility and clinical effectiveness of SEMS
|
Technical success rate 100 %
Clinical success rate 98 %
There were no procedure-related major complications
Procedure-related minor complications:
-
Hematochezia: 14 %
-
Tenesmus: 2 %
-
Anal pain: 2 %
|
Low
|
|
Shrivastava,
2008 [42]
|
Retrospective
|
Radiologic colorectal SEMS insertion
Memotherm
WallFlex
|
Patients with an advanced obstructing colorectal tumor (n = 91)
|
Efficacy, risks and survival after palliative colorectal stenting
|
Technical success rate 89 %
Clinical success rate 99 %
Overall immediate success of SEMS: 88 %
Early complications (< 30 days):
|
Low
|
|
Alcantara,
2007 [44]
|
Prospective
|
Radiologic SEMS placement
Enteral Wallstent Esophacoil Hanarostent
WallFlex
|
Patients with large-bowel obstruction due to colorectal cancer (n = 95)
|
Effectiveness of stenting
|
Clinical relief of obstruction: 95 %
Complications associated with stenting:
-
Perforation: 3.8 %
-
Stent migration: 3.8 %
-
Obstruction: 3.8 %
-
Tenesmus: 1 %
|
Moderate
|
|
Sebastian,
2004 [47]
|
Systematic review
|
Colorectal SEMS placement
|
Patients with malignant colorectal obstruction (n = 1198)
54 case series
|
Efficacy and safety of SEMS
|
Technical failure rates for combined radiologic/endoscopic stent placement and stent placement with fluoroscopic guidance only: 4.5 % and 9.6 %, respectively (P = 0.086)
|
Moderate
|
Table e2 b (a – i)
Technical considerations of stent placement. (b) Stricture dilation.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Van Halsema,
2014 [51]
|
Meta-analysis
|
Colorectal SEMS placement
|
All patients who underwent colorectal stent placement (n = 4086)
|
Risk factors for perforation from colonic stenting
|
Pooled perforation rate:
-
No dilation: 8.5 % (95 %CI 7.2 % – 10.0 %)
-
Overall stricture dilation: 8.5 % (95 %CI 5.5 % – 12.8 %)
-
Pre-stenting dilation: 8.2 % (95 %CI 4.0 % – 16.1 %)
-
Re-intervention dilation: 20.4 % (95 %CI 6.5 % – 48.8 %)
|
Moderate
|
|
Meisner,
2011 [12]
|
Prospective cohort
|
WallFlex colonic stent placement
|
Patients with malignant colonic obstruction (n = 463)
-
Palliative SEMS placement (n = 255)
-
SEMS as bridge to surgery (n = 182)
-
Indication not specified (n = 10)
|
Performance, safety and effectiveness of colorectal stents
|
Pre-stenting dilation: 3.2 %
30-day cumulative perforation rate: 3.9 %
Post hoc analysis:
Odds of perforation after pre-stenting dilation 9.41 times higher than without dilation (P = 0.0017)
|
Moderate
|
|
Yoon,
2011 [8]
|
Retrospective
|
Colorectal SEMS insertion
Niti-S covered
Comvi stent
WallFlex
Niti-S D-type
|
Patients with malignant colorectal obstruction (n = 412)
|
Rates and factors predictive of technical and clinical failure of SEMS
|
Immediate clinical success rate for:
Multivariate analysis of long-term clinical failure:
|
Low
|
|
Small,
2010 [15]
|
Retrospective
|
Colonic SEMS placement
Ultraflex
Wallstent
WallFlex
|
Patients with malignant colorectal obstruction (n = 233)
|
Long-term efficacy, incidence of complications, and risk factors of SEMS placement
|
Univariate analysis of factors associated with major complications:
Stricture dilation (P = 0.026):
Perforation rate (P = 0.027):
|
Low
|
|
Tanaka,
2010 [49]
|
Experimental
|
Immediately after surgical resection, an 18 mm balloon was placed in the stricture and slowly inflated with hydrostatic pressure over 1 minute and kept at maximum diameter for 1 minute
|
Patients with strictured colorectal cancers of < 15 mm in internal diameter (n = 47)
|
Risk factors associated with perforation in excised colorectal cancer specimens
|
Perforation rate: 17.0 % (8/47)
Univariate analysis for risk factors associated with perforation:
-
Annular vs. half-annular/subannular strictures: 34.8 % vs. 0 % (P = 0.020)
-
Mean internal diameter of perforated vs. nonperforated cases: 4.9 mm vs. 8.3 mm (P = 0.001)
-
Collagen fibers per visual field of perforated vs. nonperforated cases: 30.8 % vs. 12.0 % (P < 0.0001)
|
Low
|
|
Sebastian,
2004 [47]
|
Systematic review and pooled analysis
|
Colorectal SEMS placement
|
Patients with malignant colorectal obstruction (n = 1198)
54 case series
|
Efficacy and safety of SEMS
|
Pre-dilation to allow passage of guidewire (n = 96)
Perforation rate: 3.8 %
Pre-dilation was significantly associated with perforation and was thought to be responsible in 16 cases (17.7 %)
Stent migration rate: 11.8 %
Risks for increased rate of stent migration: laser treatment, dilation prior to stent insertion and chemotherapy and radiotherapy
|
Moderate
|
|
Khot,
2002 [50]
|
Systematic review and pooled analysis
|
Colorectal SEMS placement
|
Patients with colorectal obstruction (n = 598)
29 case series
Malignant strictures: 97 %
Benign strictures: 3 %
|
Safety and efficacy of colorectal SEMS
|
Perforation rate: 3.7 %
Perforation incidence in non-balloon dilation group 2.4 % (12/493) vs. 9.5 % (10/105) in balloon dilation group (P < 0.05)
|
Moderate
|
Table e2 c (a – i)
Technical considerations of stent placement. (c) Stent covering.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Yang,
2013 [53]
|
Systematic review and meta-analysis
|
Covered and uncovered SEMS placement for palliative treatment
|
Patients with cancerous obstruction in any position of the digestive tract
1 RCT and 2 nonrandomized prospective studies
Covered SEMS (n = 147)
Uncovered SEMS (n = 152)
|
Clinical outcomes of covered and uncovered SEMS
|
Covered versus uncovered SEMS for colorectal obstruction
Time to recurrence of obstruction: HR = 0.89 (95 %CI 0.18 – 4.45)
No differences in technical and clinical success
Significantly lower tumor ingrowth using covered SEMS
Tumor overgrowth: RR = 2.68 (95 %CI 0.54 – 13.33)
Stent migration: RR = 11.70 (95 %CI 2.84 – 48.27)
|
High
|
|
Zhang,
2012 [52]
|
Systematic review and meta-analysis
|
Uncovered and covered SEMS placement
|
Patients with malignant colorectal obstruction
1 RCT 3 prospective and 2 retrospective comparative studies
Covered SEMS (n = 218)
Uncovered SEMS (n = 246)
|
Efficacy of uncovered and covered SEMS
|
Uncovered versus covered SEMS:
Technical success rate: 99.6 % vs. 97.2 %; RR 1.01 (95 %CI 0.98 – 1.04); P = 0.48
Clinical success rate: 96.4 % vs. 93.8 %; RR 1.03 (95 %CI 0.98 – 1.09); P = 0.26
Tumor ingrowth rate: 11.4 % vs. 0.9 %; RR 5.99 (95 %CI 2.23 – 16.10); P = 0.0004
Early (≤ 7 days) migration rate: 2.9 % vs. 6.9 %; RR 0.73 (95 %CI 0.27 – 2.00); P = 0.54
Late (> 7 days) migration rate: 5.5 % vs. 21.3 %; RR 0.25 (95 %CI 0.08 – 0.80); P = 0.02
Perforation rate: 0.4 % vs. 0.9 %; RR 0.50 (95 %CI 0.08 – 3.11); P = 0.46
Overall complication rate: 21.5 % vs. 32.1 %; RR 0.79 (95 %CI 0.58 – 1.09); P = 0.16
Stent patency was significantly longer for uncovered SEMS, weighted mean difference 15.3 days (95 %CI 4.31 – 26.37); P = 0.006. However, this was nonsignificant in sensitivity analysis (P = 0.22)
|
High
|
Table e2 d (a – i)
Technical considerations of stent placement. (d) Stent size.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Abbott,
2014 [11]
|
Retrospective
|
Palliative endoscopic SEMS insertion
Wallstent
Taewoong
Schneider
|
Patients with colonic obstruction due to colorectal cancer or metastatic extracolonic disease (n = 146)
|
Technical success and complication rates of SEMS, and identifying any predictors of stent-related complications and re-intervention
|
Technical success rate: 97.3 %
Clinical success rate: 95.8 %
Overall complication rate: 39.7 %
Overall re-intervention rate: 30.8 %
-
Endoscopic: 18.5 %
-
Surgical: 14.4 %
Predictors of early complications:
Predictors of late complications:
Predictors of endoscopic re-intervention:
Predictors of surgical treatment:
|
Low
|
|
Geraghty,
2014 [16]
|
Retrospective
|
Colonic stenting for large-bowel obstruction
|
Patients in whom SEMS placement was attempted for large-bowel obstruction (n = 334)
|
Outcome of colonic stenting and factors associated with successful intervention
|
Univariate analysis of factors related to technical success:
Stent length (P = 0.521):
-
Length ≥ 10 cm: 88.6 %
-
Length < 10 cm: 91.2 %
Stent diameter (P = n.s.):
-
Diameter ≥ 25 mm: 95.2 %
-
Diameter < 25 mm: 88.0 %
Univariate analysis of factors related to clinical success:
Stent length (P = 0.907):
-
Length ≥ 10 cm: 91.1 %
-
Length < 10 cm: 91.6 %
Stent diameter (P = 0.161):
-
Diameter ≥ 25 mm: 95.2 %
-
Diameter < 25 mm: 87.4 %
|
Low
|
|
Kim BC,
2012 [54]
|
Retrospective
|
Colorectal SEMS insertion
WallFlex Enteral
Niti-S D-type uncovered
Niti-S Comvi covered
|
Patients with malignant colorectal obstruction
Palliative SEMS placement (n = 54)
SEMS as bridge to surgery (n = 48)
|
Clinical outcomes of palliative SEMS placement
|
Risk factors for complications:
SEMS diameter (P = n.s.):
-
Diameter < 24 mm: 71.4 %
-
Diameter ≥ 24 mm: 42.6 %
SEMS length (P = n.s.):
-
Length < 100 mm: 48.8 %
-
Length ≥ 100 mm: 38.5 %
Risk factors for stent migration:
SEMS diameter (P < 0.05):
-
Diameter < 24 mm: 71.4 %
-
Diameter ≥ 24 mm: 12.8 %
SEMS length (P = n.s.):
-
Length < 100 mm: 22.0 %
-
Length ≥ 100 mm: 15.4 %
Risk factors for stent re-obstruction:
SEMS diameter (P = n.s.):
-
Diameter < 24 mm: 0 %
-
Diameter ≥ 24 mm: 8.5 %
SEMS length (P = n.s.):
-
Length < 100 mm: 7.3 %
-
Length ≥ 100 mm: 7.7 %
|
Low
|
|
Manes,
2011 [55]
|
Retrospective
|
Colonic stent placement
WallFlex
Wallstent
Ultraflex
Hanarostent
Bonastent
Evolution
|
Patients with incurable malignant colonic obstruction (n = 201)
|
Short- and long-term efficacy of SEMS
|
Overall major complication rate: 11.9 %
Small-caliber SEMS (< 25 mm) were associated with stent migration: OR 7.0 (95 %CI 1.9 – 24.6); P = 0.002
|
Low
|
|
Selinger,
2011 [45]
|
Retrospective
|
Radiologic colonic stent insertion
Hanarostent Wallstent
Choo stent Niti-S
Others
|
Patients who underwent colonic SEMS insertion (n = 96)
|
Factors associated with technical and clinical outcomes of SEMS placement
|
Clinical long-term success:
Factors influencing long-term clinical success:
|
Low
|
|
Yoon,
2011 [8]
|
Retrospective
|
Colorectal SEMS insertion
Niti-S covered
Comvi stent
WallFlex
Niti-S D-type
|
Patients with malignant colorectal obstruction (n = 412)
|
Rates and factors predictive of technical and clinical failure of SEMS
|
Immediate clinical success rate for:
Stent length (P = 0.992):
-
Length < 10 cm: 83.7 %
-
Length ≥ 10 cm: 83.8 %
|
Low
|
|
Small,
2010 [15]
|
Retrospective
|
Colonic SEMS placement
Ultraflex
Wallstent
WallFlex
|
Patients with malignant colorectal obstruction (n = 233)
|
Long-term efficacy, incidence of complications, and risk factors of SEMS placement
|
Univariate analysis of factors associated with major complications:
Stent diameter (P = 0.001)
-
Diameter ≤ 22 mm: 31.9 %
-
Diameter 25 mm: 13.3 %
|
Low
|
|
Im,
2008 [56]
|
Prospective
|
Palliative colorectal uncovered SEMS placement
|
Palliative endoscopic SEMS placement for a malignant colorectal obstruction (n = 49)
|
Clinical outcomes and factors associated with long-term complications and patency of SEMS
|
Univariate analysis of long-term complications:
Stent diameter (P = 0.48):
-
Diameter ≤ 22 mm: 27 %
-
Diameter 24 mm: 15.4 %
|
Low
|
Table e2 e (a – i)
Technical considerations of stent placement. (e) Stent model.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Cheung,
2012 [58]
|
RCT
|
Colonic SEMS placement
Taewoong D-type uncovered stent (n = 52)
Boston Scientific WallFlex stent (n = 71)
|
Patients with acute malignant colonic obstruction
|
Clinical outcome and safety of the D-type stent and the WallFlex stent
|
WallFlex versus Taewoong D-Type
Palliative group:
-
Technical success rate: 100 % vs. 100 %
-
Clinical success rate: 100 % vs. 100 %
-
Perforation rate: 3.6 % vs. 0 % (P = 0.296)
-
Migration rate: 3.6 % vs. 3.3 % (P = 0.296)
-
Re-stenosis rate: 3.6 % vs. 0 % (P = 0.296)
Bridge-to-surgery group:
-
Technical success rate: 93 % vs. 95.5 % (P = 0.700)
-
Clinical success rate: 86 % vs. 90.1 % (P = 0.681)
-
Perforation rate: 7 % vs. 4.5 % (P = 0.683)
-
Migration rate: 0 % vs. 0 %
-
Re-stenosis rate: 2.3 % vs. 0 % (P = 0.465)
Mean length of stenosis for perforation vs. no perforation: 60 mm vs. 50 mm (P = 0.249)
|
Moderate
|
|
Park JK,
2011 [59]
|
Retrospective
|
Through-the-scope palliative SEMS insertion
Uncovered:
-
Wallstent
-
Niti-S
-
Bonastent
-
Hanarostent
Covered:
|
Patients with incurable malignant colorectal obstruction (n = 103)
|
Success rates and complication rates according to stent type
|
Uncovered SEMS group (n = 73)
Technical success rates: Wallstent 100 %, Niti-S 100 %, and Bonastent 100 % (P = n.s.)
Clinical success rates: Wallstent 100 %, Niti-S 100 %, and Bonastent 100 % (P = n.s.)
Overall complication rate: Wallstent 37 %, Niti-S 20 %, Bonastent 9 % (P = 0.065)
Occlusion rates: Wallstent 11.1 %, Niti-S 5 %, and Bonastent 9 % (P = 0.761)
Migration rates: Wallstent 25.9 %, Niti-S 15 %, and Bonastent 0 % (P = 0.037)
Stent patency up to death: Wallstent 63 %, Niti-S 80 %, and Bonastent 91 % (P = 0.065)
|
Low
|
|
Yoon,
2011 [8]
|
Retrospective
|
Colorectal SEMS insertion
Niti-S covered
Comvi stent
WallFlex
Niti-S D-type
|
Patients with malignant colorectal obstruction (n = 412)
|
Rates and factors predictive of technical and clinical failure of SEMS
|
Immediate clinical success rate for stent manufacturer (P = 0.354):
-
Covered Niti-S stent: 87.2 %
-
Covered Comvi stent: 70 %
-
Uncovered WallFlex stent: 84.3 %
-
Uncovered Niti-S D-type stent: 84.5 %
|
Low
|
|
Kim JH,
2009 [43]
|
Prospective nonrandomized
|
Radiologic dual-design SEMS insertion
Flared ends (n = 69)
Bent ends (n = 53)
|
Patients with malignant colorectal obstruction (n = 122)
|
Clinical safety and efficacy of dual-design stents
|
Flared-ends versus bent-ends
Technical success rate: 94.2 % vs. 96.2 % (P = 0.696)
Clinical success rate: 93.8 % vs. 90.2 % (P = 0.504)
Overall complication rate: 18.5 % vs. 25.5 % (P = 0.361)
Perforation rate: 6.2 % vs. 5.9 % (P > 0.999)
Stent migration rate: 6.2 % vs. 5.9 % (P > 0.999)
|
Moderate
|
|
Small,
2008 [60]
|
Retrospective
|
Through-the-scope (TTS) Enteral Wallstent or non-TTS Precision Colonic Ultraflex stent placement
|
Patients with malignant left-sided colon obstruction
Wallstent TTS (n = 50)
Ultraflex OTW (n = 35)
|
Outcomes after palliative placement of the Enteral Wallstent (EW) and the Precision Colonic Ultraflex (PCU) stent
|
Wallstent versus Ultraflex
Technical success rate: 94 % vs. 100 % (P = n.s.)
Technical difficulty: 16 % vs. 9 % (P = n.s.)
Complication rate: 60 % vs. 40 % (P = 0.035)
Stent occlusion rate: 18 % vs. 11 % (P = n.s.)
Median stent patency: 63 vs. 134 days
Re-intervention rate: 62 % vs. 40 % (P = 0.02)
|
Low
|
|
Garcia-Cano,
2006 [61]
|
Retrospective
|
Colorectal SEMS insertion
Enteral Wallstent
Hanarostent Ultraflex Precision
|
Patients with malignant colorectal obstruction (n = 175)
|
Technical and clinical success of SEMS
|
Technical success rate (P = n.s.):
-
Wallstent: 92.4 %
-
Hanarostent: 88.5 %
-
Ultraflex: 96.7 %
Clinical success rate (P = n.s.):
-
Wallstent: 83.6 %
-
Hanarostent: 95.7 %
-
Ultraflex: 82.8 %
Overall complication rate (P = n.s.):
-
Wallstent: 18.5 %
-
Hanarostent: 15.3 %
-
Ultraflex: 20 %
|
Low
|
Table e2 f (a – i)
Technical considerations of stent placement. (f) SEMS placement for proximal colonic cancers
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Abbott,
2014 [11]
|
Retrospective
|
Palliative endoscopic SEMS insertion
Wallstent
Taewoong
Schneider
|
Patients with colonic obstruction due to colorectal cancer or metastatic extracolonic disease (n = 146)
|
Technical success and complication rates of SEMS, and identifying any predictors of stent-related complications and re-intervention
|
Predictors of early complications:
Predictors of late complications:
Predictors of endoscopic re-intervention:
Predictors of surgical treatment:
|
Low
|
|
Geraghty,
2014 [16]
|
Retrospective
|
Colonic stenting for large-bowel obstruction
|
Patients in whom SEMS placement was attempted for large-bowel obstruction (n = 334)
|
Outcome of colonic stenting and factors associated with successful intervention
|
Univariate analysis of factors related to technical success:
Obstruction site (P = 0.602):
-
Proximal colon: 90.0 %
-
Distal colon: 87.1 %
Univariate analysis of factors related to clinical success:
Obstruction site (P = 0.645):
-
Proximal colon: 87.5 %
-
Distal colon: 84.7 %
|
Low
|
|
Kim JY,
2013 [65]
|
Retrospective
|
Endoscopic SEMS (M.I. Tech) placement
|
Patients with malignant colorectal obstruction (n = 209)
-
Right colon (n = 43)
-
Left colon (n = 166)
|
Clinical outcomes of SEMS in patients with colorectal cancer and those with extracolonic malignancy
|
Multivariate analysis of risk factors for complications:
|
Low
|
|
Cho,
2011 [62]
|
Retrospective
|
Endoscopic stent insertion
Hanarostent
Bonastent
|
Patients with malignant colon obstruction
Proximal to the splenic flexure (n = 37)
Distal colon (n = 99)
|
Technical feasibility and clinical outcomes of SEMS insertion for proximal and distal colon obstruction
|
Proximal versus distal colon
Technical success rate: 86 % vs. 97 % (P = 0.06)
Clinical success rate: 78 % vs. 91 % (P = 0.08)
Complication rate: 24 % vs. 27 % (P = 0.89)
Perforation rate: 5 % vs. 0 % (P = 0.15)
Re-occlusion rate: 11 % vs. 18 % (P = 0.47)
Stent migration rate: 8 % vs. 8 % (P = 0.73)
Median stent patency: 120 days vs. 186 days
Median survival: 124 days vs. 348 days
|
Low
|
|
Selinger,
2011 [45]
|
Retrospective
|
Radiologic colonic stent insertion
Hanarostent Wallstent
Choo stent Niti-S
Others
|
Patients who underwent colonic SEMS insertion (n = 96)
|
Factors associated with technical and clinical outcomes of SEMS placement
|
Technical and clinical success rate: 83.3 % and 77.1 %
Early and late complication rates: 10 % and 26.3 %
Clinical long-term success:
Overall: 77 % (44/57)
Colorectal malignancy: 81 % (38/47)
Factors influencing short-term clinical success:
Factors influencing long-term clinical success:
|
Low
|
|
Yao,
2011 [63]
|
Retrospective
|
Endoscopic decompression using SEMS as bridge to one-stage surgery
|
Patients with acute colon obstruction proximal to splenic flexure (n = 81)
|
Usefulness of SEMS as bridge to surgery in the management of acute proximal colon obstruction
|
Technical success rate: 96.3 %
Clinical success rate: 96.3 %
One-stage surgery: 92.3 % (72/78) with 3.8 % morbidity
|
Low
|
|
Yoon,
2011 [8]
|
Retrospective
|
Colorectal SEMS insertion
Niti-S covered
Comvi stent
WallFlex
Niti-S D-type
|
Patients with malignant colorectal obstruction (n = 412)
|
Rates and factors predictive of technical and clinical failure of SEMS
|
Multivariate analysis of factors associated with technical failure in the palliative group:
Obstruction site (P = 0.034):
Univariate analysis of factors associated with immediate clinical failure in palliative group:
Obstruction site (P = 0.245):
-
Right colon: 11.1 %
-
Left colon: 17.7 %
|
Low
|
|
Small,
2010 [15]
|
Retrospective
|
Colonic SEMS placement
Ultraflex
Wallstent
WallFlex
|
Patients with malignant colorectal obstruction (n = 233)
|
Long-term efficacy, incidence of complications and risk factors of SEMS placement
|
Univariate analysis of major complications:
Site of obstruction (P = 0.138):
-
Right colon: 17.1 %
-
Left colon: 25.8 %
|
Low
|
|
Dronamraju,
2009 [66]
|
Retrospective
|
Colonic Enteral Wallstent insertion
|
Patients with malignant large-bowel obstruction (n = 97)
Proximal to splenic flexure (n = 16)
Distal colon (n = 81)
|
Outcomes following stenting for lesions proximal to the splenic flexure
|
Proximal versus distal colon
Successful stenting: 87.5 % vs. 78.9 % (P = 0.6)
Complication rate: 7.1 % vs. 8.6 % (P = 0.3)
Hospital stay: 1.6 days vs. 2.0 days (P = 0.9)
|
Low
|
|
Repici,
2007 [64]
|
Retrospective
|
Colonic SEMS insertion
Wallstent
WallFlex
|
Patients with right-sided malignant colonic obstruction (n = 21)
|
Outcome after colonic stent placement into the proximal colon
|
Technical success rate: 95.2 %
Clinical success rate: 85 %
Complication rate: 4.8 %
Re-occlusion due to tumor ingrowth: 4.8 %
Median follow-up: 8 months (range 3 – 13)
|
Low
|
Table e2 g (a – i)
Technical considerations of stent placement. (g) Colonic SEMS placement for obstruction caused by extracolonic malignancy (ECM).
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Abbott,
2014 [11]
|
Retrospective
|
Palliative endoscopic SEMS insertion
Wallstent
Taewoong
Schneider
|
Patients with colonic obstruction due to colorectal cancer or metastatic extracolonic disease (n = 146)
|
Technical success and complication rates of SEMS, and identifying any predictors of stent-related complications and re-intervention
|
Predictors of early complications:
Predictors of late complications:
Predictors of endoscopic re-intervention:
Predictors of surgical treatment:
|
Low
|
|
Kim JY,
2013 [65]
|
Retrospective
|
Endoscopic SEMS (M.I. Tech) placement
|
Patients with malignant colorectal obstruction (n = 209)
|
Clinical outcomes of SEMS in patients with colorectal cancer and those with extracolonic malignancy
|
CRC versus ECM
Technical success rate: 99.3 % vs. 95.2 % (P = 0.079)
Clinical success rate: 92.6 % vs. 86.7 % (P = 0.688)
Re-obstruction: 21.9 % vs. 30 % (P = 0.288)
Stent migration: 5.5 % vs. 1.7 % (P = 0.378)
Perforation: 4.1 % vs. 8.3 % (P = 0.467)
10-day mortality: 2.7 % vs. 3.3 % (P = 1.000)
Median stent patency: 193 vs. 186 days (P = 0.253)
Multivariate analysis of risk factors for complications:
|
Low
|
|
Moon,
2013 [69]
|
Retrospective
|
Palliative uncovered SEMS placement
Hanarostent
Bonastent
|
Patients with malignant colonic obstruction (n = 97)
-
CRC (n = 53)
-
ECM (n = 44)
|
Success and complications of stent placement in patients with extracolonic malignancy
|
CRC versus ECM
Technical success rate: 98.1 % vs. 93.2 % (P = 0.326)
Clinical success rate: 84.9 % vs. 77.3 % (P = 0.433)
Overall early complication rate: 5.8 % vs. 9.6 % (P = 0.343)
Median stent patency: 177 days vs. 117 days (P = 0.015)
Median overall survival: 402 vs. 141 days (P = 0.018)
|
Low
|
|
Keranen,
2012 [70]
|
Retrospective
|
Colorectal SEMS insertion
Memotherm
Ultraflex
WallFlex
Wallstent
Choo stent
Instent
|
Patients with malignant colorectal obstruction (n = 101)
Palliation group:
CRC (n = 66)
ECM (n = 24)
|
Efficacy and safety of SEMS for colorectal cancer and extracolonic malignancies
|
CRC versus ECM
Technical success rate: 100 % vs. 96 % (P = n.s.)
Clinical success rate: 94 % vs. 65 % (P < 0.001)
Overall complication rate: 20 % vs. 29 % (P = 0.497)
Median survival: 158 vs. 49 days (P = 0.030)
|
Low
|
|
Kim BK,
2012 [71]
|
Retrospective
|
SEMS placement compared with emergency surgery
Wallflex uncovered
Comvi covered stent
Niti-s D-type uncovered
|
Patients with malignant colorectal obstruction due to advanced gastric cancer (n = 180)
|
Clinical outcomes and complications
|
Outcomes of SEMS placement
Technical success rate: 73.9 %
Clinical success rate: 54.1 %
Acute complication rate: 3.6 %
Overall complication rate: 62.4 %
-
Re-obstruction: 40 %
-
Stent migration: 9.4 %
-
Perforation: 9.4 %
-
Bleeding: 3.5 %
SEMS versus emergency surgery:
Technical success rate: 74 % vs. 94 % (P = 0.001)
Clinical success rate: 54 % vs. 75 % (P = 0.005)
Early (≤ 1 month) complication rate: 29 % vs. 29 % (P = 1.000)
Late (> 1 month) complication rate: 21 % vs. 16 % (P = 0.557)
Procedure-related mortality: 4 % vs. 9 % (P = 0.307)
Stoma formation: 27 % vs. 46 % (P = 0.010)
Median patency: 117 vs. 183 days (P = 0.105)
Overall survival: 8.5 vs. 9.5 months (P = 0.217)
|
Low
|
|
Kim JH,
2011 [72]
|
Retrospective
|
Palliative Dual-design stent placement
|
Patients with inoperable malignant colonic obstruction (n = 108)
-
CRC (n = 58)
-
ECM (n = 50)
|
Clinical outcomes of SEMS for CRC and ECM
|
CRC versus ECM
Technical success: 84 % vs. 94 % (P = 0.137)
Clinical success rate: 98 % vs. 96 % (P = 0.533)
Perforation rate: 2 % vs. 11 % (P = 0.082)
Migration rate: 10 % vs. 4 % (P = 0.262)
Bleeding: 6 % vs. 9 % (P = 0.653)
Pain: 4 % vs. 13 % (P = 0.124)
Tumor ingrowth: 6 % vs. 2 % (P = 0.328)
Median overall survival: 4.6 vs. 4.1 months (P = 0.67)
Median symptom-free survival: 4 vs. 3 months (P = 0.07)
|
Low
|
|
Manes,
2011 [55]
|
Retrospective
|
Colonic stent placement
WallFlex
Wallstent
Ultraflex
Hanarostent
Bonastent
Evolution
|
Patients with incurable malignant colonic obstruction (n = 201)
|
Short- and long-term efficacy of SEMS
|
Technical success rate: 91.5 %
Immediate clinical success rate: 89.7 %
Univariate analysis of factors associated with technical failure:
Univariate analysis of factors associated with clinical failure:
|
Low
|
|
Yoon,
2011 [8]
|
Retrospective
|
Colorectal SEMS insertion
Niti-S covered
Comvi stent
WallFlex
Niti-S D-type
|
Patients with malignant colorectal obstruction (n = 412)
Palliative SEMS (n = 276)
SEMS as bridge to surgery (n = 136)
|
Rates and factors predictive of technical and clinical failure of SEMS
|
Multivariate analysis of factors associated with technical failure in the palliative group:
Origin of malignancy (P = 0.011):
Univariate analysis of factors associated with immediate clinical failure in palliative group:
Origin of malignancy (P = 0.986):
-
Extrinsic: 16.3 %
-
Intrinsic: 16.2 %
Multivariate analysis of factors associated with long-term clinical failure in the palliative group:
Extrinsic origin of malignancy: OR 1.13 (95 %CI 0.51 – 2.54); P = 0.761
|
Low
|
|
Small,
2010 [15]
|
Retrospective
|
Colonic SEMS placement
Ultraflex
Wallstent
WallFlex
|
Patients with malignant colorectal obstruction (n = 233)
|
Long-term efficacy, incidence of complications and risk factors of SEMS placement
|
Univariate analysis of major complications:
Site of lesion (P = 0.237):
-
Extrinsic: 20.4 %
-
Intrinsic: 25.1 %
|
Low
|
|
Trompetas,
2010 [73]
|
Retrospective
|
Palliative colonic stenting
|
Patients with obstructing extracolonic cancer (n = 11)
|
Clinical outcomes after colonic stenting for extracolonic cancer
|
Technical success rate: 45 % (5/11)
Clinical success rate: 27 % (3/11)
Perforation rate: 9 % (1/11)
30-day mortality rate: 36 % (4/11)
Median survival: 2 months
|
Low
|
|
Keswani,
2009 [74]
|
Retrospective
|
Placement of a colonic metal stent (Microvasive)
|
Patients with malignant colon obstruction (n = 49)
-
CRC (n = 34)
-
ECM (n = 15)
|
Success and complication rates of colorectal stenting in patients with colorectal cancer versus those with extracolonic malignancy
|
CRC versus ECM
Technical success rate: 97.1 % vs. 66.7 % (P = 0.008)
Clinical success rate: 88.6 % vs. 20 % (P < 0.001)
Surgical therapy: 5.9 % vs. 60 % (P < 0.001)
Clinical success after all therapy: 100 % vs. 80 % (P = 0.03)
Complication rate: 8.8 % vs. 33.3 % (P = 0.046)
Multivariate analysis of risk factors for endoscopic failure:
Multivariate analysis of risk factors predictive of complications:
|
Low
|
|
Shin,
2008 [75]
|
Retrospective
|
Colorectal Taewoong SEMS insertion
|
Patients with unresectable extrinsic tumors (n = 39)
|
Success rates and complications of SEMS for unresectable extrinsic tumors
|
Technical success rate: 87.2 %
Clinical success rate: 82.1 %
Complication rate: 38.6 %
|
Low
|
Table e2 h (a – i)
Technical considerations of stent placement. (h) “Stentability” based on the length of the obstructed segment.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Almadi,
2013 [77]
|
Retrospective
|
Uncovered WallFlex stent insertion
|
Patients with malignant colonic obstruction (n = 73)
-
Palliation: 35 %
-
Bridge to surgery: 65 %
|
Predictive factors for complications of colonic stenting
|
Technical success rate: 93.9 %
Complications:
-
Perforation: 4.1 %
-
Stent migration: 8.2 %
-
Re-occlusion: 2.7 %
Mean length of stenosis for complications vs. no complications: 5.43 vs. 5.09 cm (P = 0.49)
Length of stenosis not associated with survival (P = 0.95)
|
Low
|
|
Cheung,
2012 [58]
|
RCT
|
Colonic SEMS placement
Taewoong D-type uncovered stent (n = 52)
Boston Scientific WallFlex stent (n = 71)
|
Patients with acute malignant colonic obstruction
Palliative SEMS placement (n = 58)
SEMS as bridge to surgery (n = 65)
|
Clinical outcome and safety of the D-type stent and the WallFlex stent
|
Mean length of stenosis for perforated cases (n = 5) versus nonperforated cases: 60 mm vs. 50 mm (P = 0.249)
|
Moderate
|
|
Luigiano,
2011 [76]
|
Prospective
|
Endoscopic WallFlex placement for palliation
|
Patients with malignant colorectal obstruction (n = 39)
|
Outcomes of through-the-scope large diameter SEMS placement for palliation
|
Technical success rate: 92.3 %
Clinical success rate: 89.7 %
Technical failure was related to extracolonic etiology (P < 0.001)
No correlation between clinical failure and:
-
Length of stenosis
-
Type of malignancy
-
Stricture location
-
Degree of obstruction
Complications:
-
Perforation: 5.6 %
-
Tumor ingrowth: 17.1 %
-
Stent migration: 2.8 %
No correlation between complications and:
-
Length of stenosis
-
Type of malignancy
-
Stricture location
-
Degree of occlusion
Univariate and multivariate analyses did not show any factors related to long-term clinical success and survival
|
Low
|
|
Manes,
2011 [55]
|
Retrospective
|
Colonic stent placement
WallFlex
Wallstent
Ultraflex
Hanarostent
Bonastent
Evolution
|
Patients with incurable malignant colonic obstruction (n = 201)
|
Short- and long-term efficacy of SEMS
|
Technical success rate: 91.5 %
Immediate clinical success rate: 89.7 %
Univariate analysis of factors associated with technical failure:
Univariate analysis of factors associated with clinical failure:
|
Low
|
|
Jung,
2010 [78]
|
Retrospective
|
Palliative colorectal SEMS placement
Niti-S covered
Hanarostent
WallFlex
Niti-S D-type
|
Patients with malignant colorectal obstruction (n = 39)
|
Clinical outcomes and risk factors associated with the long-term outcomes of palliative SEMS
|
Technical success rate: 100 %
Clinical success rate: 87.2 %
Complications:
-
Perforation: 5.1 %
-
Stent migration: 10.3 %
-
Tumor ingrowth: 2.9 %
Mean event-free survival for:
-
Stent length < 10 cm vs. ≥ 10 cm: 151 vs. 60 days (P = 0.008)
-
Proximal vs. distal obstructions: 36 vs. 123 days (P = 0.015)
-
Stent diameter < 22 mm vs. ≥ 22 mm: 87 vs. 121 days (P = 0.502)
Multivariate analysis of risk factors for long-term efficacy:
|
Low
|
Table e2 i
(a – i) Technical considerations of stent placement. (i) “Stentability” based on the degree of obstruction.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Choi,
2013 [13]
|
Retrospective
|
Colorectal SEMS placement
Niti-S
Hanarostent
Choostent
Bonastent
Covered 27 %
Uncovered 73 %
|
Patients with malignant colorectal obstruction (n = 152)
|
Clinical effectiveness, complications and risk factors associated with the complications of SEMS placement
|
Multivariate analysis of risk factors for complications:
Degree of obstruction (P = 0.042) :
|
Low
|
|
Manes,
2011 [55]
|
Retrospective
|
Colonic stent placement
WallFlex
Wallstent
Ultraflex
Hanarostent
Bonastent
Evolution
|
Patients with incurable malignant colonic obstruction (n = 201)
|
Short- and long-term efficacy of SEMS
|
Technical success rate: 91.5 %
Immediate clinical success rate: 89.7 %
Univariate analysis of factors associated with technical failure:
Univariate analysis of factors associated with clinical failure:
|
Low
|
|
Yoon,
2011 [8]
|
Retrospective
|
Colorectal SEMS insertion
Niti-S covered
Comvi stent
WallFlex
Niti-S D-type
|
Patients with malignant colorectal obstruction (n = 412)
|
Rates and factors predictive of technical and clinical failure of SEMS
|
Univariate analysis of factors associated with technical success in the palliative group:
Degree of obstruction (P = 0.214):
-
Total: 85.3 %
-
Subtotal: 90.7 %
Univariate analysis of factors associated with immediate clinical success in palliative group:
Degree of obstruction (P = 0.621):
-
Total: 84.6 %
-
Subtotal: 82.1 %
|
Low
|
|
Small,
2010 [15]
|
Retrospective
|
Colonic SEMS placement
Ultraflex
Wallstent
WallFlex
|
Patients with malignant colorectal obstruction (n = 233)
|
Long-term efficacy, incidence of complications and risk factors of SEMS placement
|
Univariate analysis of major complications:
Degree of obstruction (P = 0.010):
-
Complete: 35 %
-
Subtotal: 20.2 %
|
Low
|
|
Stenhouse,
2009 [79]
|
Prospective
|
Colorectal SEMS placement
Wallstent
Memotherm
|
Patients with malignant colorectal obstruction (n = 72)
|
Outcomes of SEMS placement in complete and subtotal obstruction
|
Complete (n = 32) versus subtotal obstruction (n = 36)
Technical success rate: 84 % vs. 92 % (P = 0.46)
Clinical success rate: 65 % vs. 73 % (P = 0.58)
Overall stent migration rate: 23 %
|
Moderate
|
|
Song,
2007 [80]
|
Prospective
|
Colorectal Dual stent insertion
|
Patients with symptomatic malignant colorectal obstruction (n = 151)
-
Complete obstruction (n = 59)
-
Subtotal obstruction (n = 92)
-
Palliative SEMS placement (n = 101)
-
SEMS as bridge to surgery (n = 50)
|
Technical feasibility, clinical effectiveness, and safety of the dual colorectal stent
|
Complete versus subtotal obstruction
Technical failure rate: 15.3 % vs. 4.3 % (P = 0.034)
Overall perforation rate: 11.0 % (16/145)
Complete obstruction was a risk factor for perforation in multivariate analysis: OR 6.88 (95 %CI 2.04 – 23.17); P = 0.002
|
Moderate
|
CI, confidence interval; CRC, colorectal cancer; ECM, extracolonic malignancy; HR, hazard ratio; n.s., not significant; OR, odds ratio; OTW, over-the-wire; RCT, randomized controlled trial; RR, relative risk; SEMS, self-expandable metal stent; TTS, through-the-scope.
Table e3 a (a – c)
Self-expandable metal stent (SEMS) placement as a bridge to elective surgery. (a) Randomized controlled trials (RCTs) comparing SEMS as bridge to surgery and emergency surgery.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Ghazal,
2013 [89]
|
RCT
|
Emergency stenting followed by elective resection versus total abdominal colectomy and ileorectal anastomosis
|
Patients with acute obstructed carcinoma of the left colon
Preoperative stent (n = 30),
Emergency surgery (n = 30)
|
Feasibility, safety, clinical outcomes
|
Outcomes of stent placement
Technical and clinical success rate: 96.7 % and 100 %
No complications encountered during the 7 – 10 days until surgery
Preoperative SEMS vs. emergency surgery
Operative details:
-
Mean time: 130 vs. 176 min (P = 0.001)
-
Mean blood loss: 250 vs. 500 ml (P = 0.010)
-
Patients requiring blood transfusion: 44.8 % vs. 73.3 % (P = 0.035)
-
Patients requiring fresh frozen plasma: 10.3 % vs. 83.3 % (P = 0.010)
Overall postoperative complications: 13.8 % vs. 50 % (P = 0.012)
-
Anastomotic leakage: 0 % vs. 3.3 % (P = 1.00)
-
Wound infection: 10.3 % vs. 30 % (P = 0.022)
-
Chest infection: 3.4 % vs. 16.7 % (P = 0.098)
Median hospital stay: 13 vs. 8 days (P = 0.102)
Median bowel motions per day: 2 vs. 6 (P = 0.013)
No operative mortality in both groups
Overall median follow-up: 18 months (range 6 – 40)
Recurrent disease: 17.2 % vs. 13.3 % (P = 0.228)
|
Moderate
|
|
Tung,
2013 [90]
|
Long-term follow-up of RCT
|
SEMS placement followed by laparoscopic resection versus conventional open surgery
|
Patients with obstructing left-sided colorectal cancer (n = 48)
Endo-laparoscopic (n = 24),
Open surgery (n = 24)
|
Pathological staging, number of lymph nodes harvested, administration of adjuvant therapy, survival and disease recurrence following curative surgery
|
Emergency surgery vs. preoperative SEMS
Median lymph node harvest: 11 vs. 23 (P = 0.005)
Permanent stoma: 25 % vs. 0 % (P = 0.03)
Adjuvant chemotherapy: 54 % vs. 75 % (P = 0.2)
Median follow-up: 32 vs. 65 months (P = 0.083)
Curative intent: 54 % (13/24) vs. 92 % (22/24) (P = 0.01)
Disease recurrence rate: 23 % vs. 50 % (P = 0.4)
5-year overall survival rate: 27 % vs. 48 % (P = 0.076)
5-year disease-free survival rate: 48 % vs. 52 % (P = 0.63)
5-year survival rate for patients with stage II/III disease: 42.8 % vs. 57.1 % (P = 0.347)
|
Moderate
|
|
Ho,
2012 [91]
|
RCT
|
Colonic stenting followed by elective surgery versus immediate emergency surgery
WallFlex stent
|
Patients with acute left-sided malignant colonic obstruction with no evidence of peritonitis
SEMS as bridge to surgery (n = 20),
Emergency surgery(n = 19)
|
60-days postoperative morbidity rate, stoma, hospital stay, critical care stay, costs
|
Outcomes of SEMS placement
Technical and clinical success rate: 75 % and 93.3 %
No cases of stent-related perforation
Preoperative SEMS vs. emergency surgery
Median duration of surgery: 135 vs. 135 min (P = 0.603)
Defunctioning stoma rate: 10 % vs. 32 % (P = 0.127)
Postoperative mortality: 0 % vs. 15.8 % (P = 0.106)
Overall complication rate: 35 % vs. 58 % (P = 0.152)
Reoperation rate: 10 % vs. 11 %
Wound infection: 15 % vs. 21 %
Chest infection: 10 % vs. 11 %
Resumption of bowel function: median 4 vs. 5 days (P = 0.167)
Fit for discharge: median 6 vs. 8 days (P = 0.028)
Median bowel frequency per day: 2 vs. 2 (P = 0.653)
Total length of hospital stay: median 14 vs. 13 days (P = 0.430)
Median length of stay in critical care: 2 vs. 3 days (P = 0.057)
Median total costs: $ 18 132 vs. $ 13 301 (P = 0.194)
|
Moderate
|
|
Alcantara,
2011 [92]
|
RCT
|
Stent placement and deferred surgery versus emergency intraoperative colonic lavage with primary anastomosis
|
Patients with obstructive left-sided colonic cancer (n = 28)
Preoperative stent (n = 15),
Emergency surgery (n = 13)
|
Postoperative morbidity and mortality, staging, complications due to stent placement, surgical time, clinical follow-up, health costs, and follow-up of survival
|
No complications with stent placement were recorded
Time to surgery after SEMS: 5 – 7 days
Overall mean follow-up: 37.6 months
Preoperative SEMS vs. emergency surgery
Overall morbidity: 13.3 % vs. 53.8 % (P = 0.042)
Anastomotic dehiscence: 0 % vs. 30.8 % (P = 0.035)
Wound infection: 13.3 % vs. 15.4 % (P = 1)
Reoperation rate: 0 % vs. 30.8 % (P = 0.035)
Hospital mortality: 0 % vs. 7.7 % (P = 0.464)
Median postoperative hospital stay: 8 vs. 10 days (P = 0.05)
Median overall hospital stay: 13 vs. 10 days (P = 0.105)
Costs: € 6610 vs. € 4930 (P = 0.009)
Disease-free period: 25.5 vs. 27.1 months (P = 0.096)
Tumor reappearance: 53.3 % vs. 15.4 % (P = 0.055)
|
Moderate
|
|
Pirlet,
2011 [30]
|
RCT
|
Emergency surgery compared with SEMS as bridge to surgery
Bard uncovered SEMS
|
Patients with acute left-sided malignant large-bowel obstruction
SEMS as bridge to surgery (n = 30),
Emergency surgery (n = 30)
|
Efficiency and reduction of the stoma placement rate
|
Outcomes of SEMS placement
Technical success rate: 47 %
Clinical success rate: 85.7 %
Bridge to elective colonic resection with primary anastomosis: 40 %
Median time to surgery: 7 days (5 – 19 days)
No postoperative morbidity for all 12 successfully bridged patients
Preoperative SEMS vs. emergency surgery
Stoma placement: 43 % vs. 57 % (P = 0.30)
Restoration of bowel continuity: 30 % vs. 13 % (P = 0.12)
Median duration of stoma: 96 vs. 84 days (P = 0.68)
Successful primary anastomosis: 53 % vs. 43 % (P = 0.45)
Mortality rate: 10 % vs. 3 %
Overall abdominal complications: 23 % vs. 23 % (P = 1.000)
Anastomotic leakage: 7 % vs. 7 %
Overall extra-abdominal complications: 27 % vs. 33 % (P = 0.57)
Reoperation rate: 10 % vs. 7 %
Median cumulative hospital stay: 23 vs. 17 days (P = 0.13)
Colonic resection specimen showed 8 clinically silent bowel perforations by the stents
|
Moderate
|
|
Van Hooft,
2011 [31]
|
RCT
|
Colonic stenting as a bridge to elective surgery compared with emergency surgery
Wallstent,
WallFlex
|
Patients with acute left-sided colorectal obstruction
SEMS as bridge to surgery (n = 47),
Emergency surgery (n = 51)
|
Mean global health status, mortality, morbidity, other quality-of-life dimensions, and stoma rate
|
Outcomes of SEMS placement
Technical success rate: 70.2 %
Clinical success rate: 70.2 %
Perforation rate: 12.8 %
Bridge to elective surgery: 93.9 % (31/33)
Successful primary anastomosis: 48.4 %
Operative specimens showed 3 silent perforations
Preoperative SEMS vs. emergency surgery
Global health status: 63.0 vs. 61.4 (P = 0.36)
30-day mortality rate: 10.6 % vs. 9.8 %; RR 0.92 (95 %CI 0.28 – 2.98); P = 0.89
Overall mortality rate: 19.1 % vs. 17.6 %; RR 0.92 (95 %CI 0.40 – 2.12); P = 0.84
Morbidity rate: 53.2 % vs. 45.1 %; RR 0.85 (95 %CI 0.57 – 1.27); P = 0.43
Direct stoma rate: 51.1 % vs. 74.5 %; RR 1.46 (95 %CI 1.06 – 2.01); P = 0.016
Stoma rate at latest follow-up: 57.4 % vs. 66.7 %; RR 1.16 (0.85 – 1.59); P = 0.35
|
Moderate
|
|
Cheung,
2009 [93]
|
RCT
|
SEMS placement followed by laparoscopic resection versus open emergency surgery
Wallstent
|
Patients with an obstructing tumor between the splenic flexure and rectosigmoid junction (n = 48)
SEMS as bridge to surgery (n = 24),
Emergency surgery (n = 24)
|
Successful 1-stage operation, cumulative operative time, blood loss, hospital stay, pain score, and postoperative complications
|
Outcomes of SEMS placement
Technical success rate: 83 %
Clinical success rate: 83 %
Median time to laparoscopic resection: 10 days (2 – 16 days)
Preoperative SEMS vs. emergency surgery
Successful 1-stage operation: 67 % vs. 38 % (P = 0.04)
Permanent colostomy: 0 % vs. 25 % (P = 0.03)
Anastomotic leakage: 0 % vs. 8 % (P = 0.045)
Wound infection: 8 % vs. 33 % (P = 0.04)
Intra-abdominal abscess: 0 % vs. 4 % (P > 0.99)
Other morbidities: 0 % vs. 21 % (P = 0.02)
Cumulative hospital stay: 13.5 vs. 14 days (P = 0.7)
|
Moderate
|
Table e3 b (a – c)
Self-expandable metal stent (SEMS) placement as a bridge to elective surgery. (b) Systematic reviews and meta-analyses on SEMS as bridge to surgery.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Huang,
2014 [81]
|
Meta-analysis of RCTs
|
Preoperative colonic stents versus emergency surgery
|
Patients with acute left-sided malignant colonic obstruction
7 RCTs
SEMS as bridge to surgery (n = 195),
Emergency surgery (n = 187)
|
Efficacy and safety
|
Mean success rate of colonic stent placement: 76.9 % (46.7 % – 100 %)
Preoperative SEMS vs. emergency surgery
Permanent stoma (P = 0.002): OR 0.28 (95 %CI 0.12 – 0.62); I
2 = 36 %
Primary anastomosis (P = 0.007): OR 2.01 (95 %CI 1.21 – 3.31); I
2 = 0 %
Mortality (P = 0.76): OR 0.88 (95 %CI 0.40 – 1.96); I
2 = 17 %
Overall complications (P = 0.03): OR 0.30 (95 %CI 0.11 – 0.86); I
2 = 77 %
-
Anastomotic leak (P = 0.47): OR 0.74 (95 %CI 0.33 – 1.67); I
2 = 27 %
-
Wound infection (P = 0.004): OR 0.31 (95 %CI 0.14 – 0.68); I
2 = 0 %
-
Intra-abdominal infection (P = 0.57): OR 0.62 (95 %CI 0.12 – 3.19); I
2 = 0 %
|
High
|
|
Cennamo,
2013 [82]
|
Meta-analysis of RCTs
|
Colorectal stenting as palliation or bridge to surgery compared with emergency surgery
|
Patients with obstructing colorectal cancer (n = 353)
8 RCTs
Palliative SEMS placement (n = 37),
SEMS as bridge to surgery (n = 141),
Emergency surgery (n = 175)
|
Morbidity, mortality, stoma rate
|
Outcomes of SEMS placement
Technical and clinical success rate: 73.5 % and 72 %
Stent-related complication rate: 10 %
-
Perforation: 8.4 %
-
Stent migration: 0.5 %
-
Obstructions: 1.1 %
SEMS versus emergency surgery
Mortality: 8.4 % vs. 8 %; OR 0.91 (95 %CI 0.29 – 2.79)
Morbidity: 36 % vs. 46.3 %; OR 2.05 (95 %CI 0.67 – 6.29)
Permanent stoma: 25 % vs. 48.1 %; OR 3.12 (95 %CI 1.89 – 5.17)
Preoperative SEMS vs. emergency surgery
Primary anastomosis: 65.2 % vs. 46.8 %; OR 0.42 (95 %CI 0.25 – 0.73)
Stoma creation: 36.9 % vs. 55.4 %; OR 2.36 (95 %CI 1.37 – 4.07)
|
High
|
|
Cirocchi,
2013 [83]
|
Meta-analysis of RCTs
|
Colorectal stenting as a bridge to surgery versus emergency surgery
|
Patients with intestinal obstruction from left-sided colorectal cancer
3 RCTs
SEMS as bridge to surgery (n = 97),
Emergency surgery (n = 100)
|
Clinical success, 30-day mortality, overall complications, survival, permanent stoma
|
Preoperative SEMS vs. emergency surgery
Clinical success rate (P < 0.001): 52.5 % vs. 99 %; OR 45.64 (95 %CI 10.51 – 198.13)
30-day postoperative mortality (P = 0.97): 8.2 % vs.9 %; OR 0.99 (95 %CI 0.23 – 4.19)
Overall complication rate (P = 0.72): 48.5 % vs. 51 %; OR 0.90 (95 %CI 0.52 – 1.58)
Overall survival: not analyzed in RCTs
Primary anastomosis (P = 0.003): 64.9 % vs. 55 %; OR 2.82 (95 %CI 1.43 – 5.54)
Overall stoma rate (P = 0.02): 45.3 % vs. 62 %; OR 0.48 (95 %CI 0.26 – 0.90)
Permanent stoma (P = 0.56): 46.7 % vs. 51.8 %; OR 0.82 (95 %CI 0.42 – 1.59)
Anastomotic leakage (P = 0.35): 9 % vs. 3.7 %; OR 2.33 (95 %CI 0.40 – 13.52)
Intra-abdominal abscess (P = 0.97): 5.1 % vs. 4.9 %; OR 1.03 (95 %CI 0.25 – 4.18)
Wound infections (P = 0.17): 5.1 % vs. 10 %; OR 0.39 (95 %CI 0.10 – 1.48)
Chest infections (P = 1.00): 6.1 % vs. 6 %; OR 1.00 (95 %CI 0.27 – 3.70)
Urinary tract infections (P = 0.33): 4 % vs. 10.2 %; OR 0.45; (95 %CI 0.09 – 2.24)
|
High
|
|
De Ceglie,
2013 [84]
|
Meta-analysis
|
Colonic stenting as bridge to surgery versus emergency surgery
|
Patients with left-sided colonic obstruction
5 RCTs
3 Prospective
5 Retrospective
1 Case-matched
SEMS as bridge to surgery (n = 405),
Emergency surgery (n = 471)
|
Treatment details, short-term adverse events, mortality and length of hospitalization
|
Outcomes of SEMS placement
Median time to elective surgery: 10 days
Technical success rate: 96.9 % (95 %CI 94.9 % – 98.9 %)
Clinical success rate: 94.2 % (95 %CI 91.4 % – 97.0 %)
Stent migration rate: 0 % (95 %CI 0.0 % – 0.4 %)
Perforation rate: 0.1 % (95 %CI 0.0 % – 0.4 %)
Silent perforation rate: 0.1 % (95 %CI 0.0 % – 0.5 %)
Preoperative SEMS vs. emergency surgery:
Stoma creation (P = 0.03): ES −27.1 % (95 %CL – 51.2, – 3.0); I
2 = 97.2 %
Protective stoma (P = 1.0): ES 0 % (95 %CL – 1.0 %, 1.1 %); I
2 = 35.5 %
Primary anastomosis (P < 0.001): ES 25.1 % (95 %CI 17.0 % – 33.2 %); I
2 = 94.9 %
Successful primary anastomosis (P < 0.001): ES 23.7 % (95 %CI 13.6 % – 33.9 %); I
2 = 83.9 %
Anastomotic leakage (P = 0.1): ES – 2.4 % (95 %CL – 5.6 %, 0.8 %); I
2 = 51.2 %
Infection (P = 0.006): ES – 7.9 % (95 %CL – 13.6 %, – 2.3 %); I
2 = 59.0 %
Other morbidities (P < 0.001): ES – 13.4 % (95 %CL – 17.9 %, – 8.8 %); I
2 = 0 %
Mortality: ES – 1.9 % (95 %CL – 4.0 %, 0.3 %); I
2 = 34.1 %
Hospital stay: ES – 1.0 % (95 %CL – 4.1 %, 2.0 %); I
2 = 0 %
|
High
|
|
Tan,
2012 [85]
|
Meta-analysis of RCTs
|
SEMS as bridge to surgery versus emergency surgery
|
Patients with acute malignant left-sided large-bowel obstruction
4 RCTs
SEMS as bridge to surgery (n = 116),
Emergency surgery (n = 118)
|
Primary anastomosis, stoma and in-hospital mortality, anastomotic leak, 30-day reoperation and surgical site infection
|
Outcomes of SEMS placement
Technical success rate 70.7 %
Clinical success rate 69.0 %
Clinical perforation rate: 6.9 %
Silent perforation rate 14 %
Preoperative SEMS vs. emergency surgery
Primary anastomosis (I
2 = 87 %):
Overall successful primary anastomosis (P < 0.001): RR 1.58 (95 %CI 1.22 – 2.04); I
2 = 0 %
Stoma rate (P = 0.004): RR 0.71 (95 %CI 0.56 – 0.89); I
2 = 0 %
Permanent stoma (P = 0.06): RR 0.75 (95 %CI 0.55 – 1.01); I
2 = 47 %
In-hospital mortality (P = 0.74): 6.9 % vs. 5.9 %; RR 1.17 (95 %CI 0.46 – 2.99); I
2 = 0 %
Anastomotic leak (P = 0.71): RR 0.72 (95 %CI 0.13 – 4.00); I
2 = 51 %
30-day reoperation (P = 0.82): RR 0.82 (95 %CI 0.15 – 4.57); I
2 = 54 %
Surgical site infection (P = 0.05): 12.9 % vs. 22.9 %; RR 0.56 (95 %CI 0.31 – 0.99); I
2 = 33 %
|
High
|
|
Ye,
2012 [86]
|
Meta-analysis
|
Preoperative SEMS placement versus emergency surgery
|
Patients with acute left-sided malignant colonic obstruction
3 RCTs
5 Retrospective
SEMS as bridge to surgery (n = 219),
Emergency surgery (n = 225)
|
Primary anastomosis, stoma formation, short term mortality and morbidity
|
Preoperative SEMS vs. emergency surgery
One-stage stoma rate (P < 0.001): RR 0.60 (95 %CI 0.48 – 0.76); I
2 = 37 %
Permanent stoma rate (P = 0.14): RR: 0.80 (95 %CI 0.59 – 1.08); I
2 = 44 %
Anastomosis rate (P < 0.001): RR 1.64 (95 %CI 1.39 – 1.94); I
2 = 9 %
Mortality (P = 0.77): RR 0.91 (95 %CI 0.50 – 1.66); I
2 = 0 %
Overall morbidity (P < 0.001): RR 0.57 (95 %CI 0.44 – 0.74); I
2 = 78 %
Anastomotic leakage (P = 0.19): RR 0.60 (95 %CI 0.28 – 1.28); I
2 = 18 %
Abscess (P = 0.68): RR 0.83 (95 %CI 0.36 – 1.95); I
2 = 0 %
Extra-abdominal complications (P = 0.13): RR 0.67 (95 %CI 0.40 – 1.12); I
2 = 0 %
|
High
|
|
Zhang,
2012 [87]
|
Meta-analysis
|
Stent as a bridge to surgery versus emergency surgery
|
Patients with obstructive colorectal cancer
2 RCTs
6 Retrospective
SEMS as bridge to surgery (n = 232),
Emergency surgery (n = 369)
|
ICU usage, success rates of stenting, primary anastomosis, stoma, perioperative mortality and complications, survival
|
Overall technical success of stenting: 87.1 %
Preoperative SEMS vs. emergency surgery
Need of intensive care (P = 0.03): RR 0.42 (95 %CI 0.19 – 0.93); I
2 = 0 %
Primary anastomosis (p = 0.001): RR 1.62 (95 %CI 1.21 – 2.16); I
2 = 75 %
Stoma creation (P = 0.04): RR 0.70 (95 %CI 0.50 – 0.99); I
2 = 11 %
Permanent stoma (P = 0.52): RR 0.39 (95 %CI 0.02 – 6.75); I
2 = 75 %
Mortality (P = 0.47): RR 0.73 (95 %CI 0.31 – 1.71); I
2 = 0 %
Overall complications (P = 0.001): RR 0.42 (95 %CI 0.24 – 0.71); I
2 = 64 %
Anastomotic leakage (P = 0.004): RR 0.31 (95 %CI 0.14 – 0.69); I
2 = 0 %
1-year overall survival (P = 0.51): RR 1.07 (95 %CI 0.87 – 1.31); I
2 = 46 %
2-year overall survival (P = 0.10): RR 1.14 (95 %CI 0.98 – 1.34); I
2 = 0 %
3-year overall survival (P = 0.39): RR 1.08 (95 %CI 0.90 – 1.31); I
2 = 0 %
|
High
|
|
Sagar,
2011 [88]
|
Cochrane systematic review
|
Colonic stenting (palliative and bridging) versus surgical decompression
|
Patients with obstructing colorectal cancers
5 RCTs
Colorectal stenting (n = 102),
Emergency surgery (n = 105)
|
Mortality, morbidity, technical and clinical success, hospital stay
|
Outcome of SEMS placement
Technical success rate: 86.0 %
Stent-related perforation rate: 5.9 %
Stent migration rate: 2.1 %
Stent obstruction rate: 2.1 %
SEMS versus emergency surgery
Clinical success rate (P = 0.001): 78.1 % vs. 98.8 %; OR 0.06 (95 %CI 0.01 – 0.32); I
2 = 0 %
30-day mortality (P = 0.53): OR 1.41 (95 %CI 0.48 – 4.14); I
2 = 0 %
Complications rate (P = 0.38): 39.2 % vs. 45.7 %; OR 0.79 (95 %CI 0.47 – 1.34); I
2 = 85 %
Wound complication rate (P = 0.62): 5.6 % vs. 12 %; OR 0.54 (95 %CI 0.05 – 6.16); I
2 = 64 %
Mean hospital stay: 11.5 vs. 17.2 days
Procedure/operating time: 114 vs. 144 min
Median blood loss: 50 vs. 350 ml
|
High
|
Table e3 c (a – c)
Self-expandable metal stent (SEMS) placement as a bridge to elective surgery. (c) Other literature on SEMS as bridge to surgery.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Gianotti,
2013 [109]
|
Prospective
|
Preoperative SEMS placement, palliative SEMS placement or emergency surgery
Hanarostent
|
Patients with colorectal obstruction
Malignant (n = 121),
Benign (n = 11)
Preoperative SEMS placement (n = 49),
Palliative SEMS placement (n = 32),
Emergency surgery (n = 51)
|
Short-term and long-term outcomes of different treatment modalities
|
Overall success rate of stenting:
-
Technical 95.3 %
-
Clinical 98.8 %
Median interval to elective surgery: 6 (2 – 20) days
Short-term stent complications: 14.1 %
-
Perforation rate: 1.2 %
-
Stent migration: 4.9 %
-
Stent occlusion: 4.9 %
-
Tenesmus: 1.2 %
-
Pain: 7.4 %
-
Bleeding: 3.7 %
Preoperative SEMS vs. emergency surgery
In-hospital mortality: 2.0 % vs. 2.0 % (P = 1.0)
Overall morbidity: 32.7 % vs. 60.8 % (P = 0.006)
Protective ileostomy: 14.3 % vs. 21.6 % (P = 0.438)
Anastomotic leak: 12.2 % vs. 19.6 % (P = 0.416)
Wound infection: 26.5 % vs. 54.9 % (P = 0.005)
Intra-abdominal abscess: 14.3 % vs. 39.2 % (P = 0.007)
Respiratory tract complication: 10.2 % vs. 37.3 % (P = 0.002)
Postoperative ICU care: 10.2 % vs. 33.3 % (P = 0.007)
Reoperation: 6.1 % vs. 19.6 % (P = 0.052)
Median overall length of hospital stay: 18 (10 – 39) days vs. 19 (8 – 128) days (P = 0.219)
Definitive stoma: 6.3 % vs. 26 % (P = 0.012)
Multivariate logistic regression analysis of
surgical morbidity:
Preoperative SEMS placement (P = 0.015): RR 0.35 (95 %CI 0.15 – 0.82)
Kaplan – Meier survival curve showed significantly increased 36-month survival in the SEMS group
|
Moderate
|
|
Lee GJ,
2013 [102]
|
Retrospective
|
SEMS as bridge to elective surgery or emergency surgery
Nitinol Taewoong stents
|
Patients with obstructive colorectal cancer (n = 77)
SEMS as bridge to surgery (n = 49),
Emergency surgery (n = 28)
|
Short-term morbidity and mortality
|
Preoperative SEMS vs. emergency surgery
Mean number of harvested lymph nodes: 26 vs. 38 (P = 0.048)
No significant difference for:
-
Hospital stay (P = 0.109)
-
Hartmann (P = 0.467)
-
Overall complications: 16.3 % vs. 25 % (P = 0.355)
-
Anastomotic leakage (P = 0.297)
-
Mortality (P = 0.183)
3-year overall survival rate: 68.8 % vs. 51.3 % (P = 0.430)
Anastomotic leakage for patients operated within 10 days or after 10 days post-SEMS placement: 20 % (3/15) vs. 0 % (0/28); P = 0.037
|
Low
|
|
Cennamo,
2012 [126]
|
Prospective
|
Emergency surgery or surgery after SEMS placement as a “bridge to surgery”
WallFlex stent
|
Patients with acute left-sided colorectal cancer obstruction (n = 86)
SEMS as bridge to surgery (n = 47),
Emergency surgery (n = 41)
|
Morbidity and mortality risks with P-POSSUM and CR-POSSUM predictive score models
|
Technical and clinical success of stenting: 95.7 % and 95.7 %
Stent-related complications: 6.7 %
Mean time to surgery in SEMS group: 19 days (range 6 – 80 days)
Preoperative SEMS vs. emergency surgery
Primary anastomosis: 100 % vs. 87.8 % (P = 0.02)
30-day mortality rate: 2.4 % vs. 9.8 %
30-day morbidity rate: 28.9 % vs. 61.0
Reoperation: 0 % vs. 12.2 % (P = 0.02)
P-POSSUM morbidity: 34.3 % vs. 70.5 % (P = 0.001)
P-POSSUM mortality: 2.4 % vs. 13.6 % (P = 0.001)
CR-POSSUM mortality: 4.9 % vs. 15.1 % (P = 0.001)
|
Moderate
|
|
Cui,
2011 [101]
[1]
|
RCT
|
Laparoscopic resection 3 or 10 days after SEMS placement versus emergency open surgery
|
Patients with obstructing left-sided colon cancer
SEMS followed by surgery after 3 days (n = 15),
SEMS followed by surgery after 10 days (n = 14),
Open emergency surgery (n = 20)
|
1-stage operation rate, length of hospital stay, rates of permanent stoma, postoperative complications
|
Patients undergoing laparoscopic surgery had:
-
Less blood loss (P < 0.001)
-
Lower permanent stoma rate (P = 0.024)
-
Less pain (P < 0.001)
-
Lower incidence of postoperative complications
-
Higher rate of 1-stage operation (P = 0.004)
Interval to surgery 3 versus 10 days
Higher 1-stage operation rate after 10 days (P = 0.001)
Lower conversion rate after 10 days (P = 0.046)
|
Moderate
|
|
Guo,
2011 [100]
|
Retrospective
|
SEMS insertion or primary surgery
Uncovered endoprothesis Nanjing
|
Patients aged ≥ 70 years diagnosed with acute left-sided colonic obstruction
SEMS (n = 34),
Emergency surgery (n = 58)
|
Mortality, avoidance of stoma, and short-term survival in elderly patients
|
SEMS versus surgery
Overall rate of successful bridging with SEMS: 79 %
Mean time to elective surgery: 9 days (range 4 – 16)
Successful relief of obstruction: 91 % vs. 100 % (P = 0.09)
Primary anastomosis rate: 79 % vs. 47 % (P = 0.002)
Temporary stoma rate: 9 % vs. 53 % (P < 0.001)
Permanent stoma rate: 6 % vs. 12 % (P = 0.34)
Median length of hospital stay: 19 vs. 14 days (P = 0.06)
Acute mortality rate: 3 % vs. 19 % (P = 0.03)
Acute complication rate: 24 % vs. 40 % (P = 0.11)
|
Low
|
|
Jiménez-Pérez,
2011 [127]
|
Prospective
|
Preoperative WallFlex stent placement
|
Patients with malignant colorectal obstruction (n = 182)
|
Efficacy and safety of the WallFlex colonic stent as a bridge to surgery
|
Outcomes of SEMS placement
Procedural success rate: 97.8 %
Major procedural complications: 3.3 %
Minor procedural complications: 1.1 %
Major post-procedural complications: 4.2 % (7/167)
Minor post-procedural complications: 0.6 %
Overall major stent complication rate: 7.8 % (13/167)
Clinical success until surgery: 94 % (141/150)
Bridge to elective surgery: 89.8 % (150/167)
-
Clinical success: 97.3 %
-
Median time to surgery: 14 days (IQR 8 – 20 days)
-
Stoma creation: 6 %
-
Post-surgical complications: 16.7 %
-
Post-surgical mortality: 2 %
-
Overall stoma performance rate: 6.6 %
-
Diverting stoma: 6 %
|
Moderate
|
|
Kim S,
2009 [103]
[1]
|
No description of study design
|
SEMS placement as bridge to surgery
|
Patients with obstructive colorectal cancer (n = 62)
Operated < 7 days (n = 26),
Operated > 7 days (n = 30)
|
Optimal time for elective radical surgery following colonic stent insertion
|
Technical and clinical success rate: 100 % and 90.3 %
Surgery < 7 days versus > 7 days
Comorbid diseases: 19.2 % vs. 56.7 % (P = 0.004)
Postoperative morbidity: 7.7 % vs. 16.7 % (P = n.s.)
Postoperative mortality: 0 % vs. 3.3 %
No difference in operation time and postoperative recovery
Adjusted with comorbid diseases, there was no significant difference for all the variables between the two groups
|
Low
|
CI, confidence interval; CL, confidence limits; ES, effect size; ICU, intensive care unit; IQR, interquartile range; n.s., not significant; RCT, randomized controlled trial; OR, odds ratio; POSSUM, Physiological and Operative Severity Score for enUmeration of Mortality and Morbidity (P-, Portsmouth; CR-, colorectal); RR, relative risk; SEMS, self-expandable metal stent.
1 Published in abstract form only.
Table e4 a (a – d)
Palliative placement of self-expandable metal stent (SEMS). (a) RCTs comparing palliative SEMS placement with emergency surgery.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Van Hooft,
2008 [123]
|
RCT
|
Through-the-scope WallFlex colorectal stent insertion versus emergency surgery
|
Patients with incurable stage IV left-sided colorectal cancer
Palliative SEMS placement (n = 11),
Emergency surgery (n = 10)
|
Survival in good health out of hospital
|
SEMS versus surgery
Median hospital-free survival in good health: 38 vs. 56 days (P = 0.68)
Median total time in hospital: 12 vs. 11 days (P = 0.46)
Median total time on ICU: 0 vs. 0 days (P = 0.30)
Median total follow-up time: 360 vs. 173 days (P = 0.67)
Number of adverse events: 11 vs. 1 (P = 0.001)
Patients suffering adverse event: 73 % (8/11) vs. 10 % (1/10); P = 0.008; RR = 7.2
|
Moderate
|
|
Fiori,
2004 [6] & 2012 [108]
|
RCT
|
Endoscopic Precision stent placement versus diverting proximal colostomy
|
Patients with stage IV unresectable rectosigmoid cancer and symptoms of chronic subacute obstruction (n = 22)
Palliative SEMS placement (n = 11),
Colostomy (n = 11)
|
Morbidity, mortality, canalization of gastrointestinal tract, restoration of oral intake, hospital stay
|
Outcomes of SEMS placement
Technical and clinical success rate: 100 % and 100 %
Hospital stay: range 2 – 4 days
Median survival: 297 days (125 – 612 days)
Late complications:
Outcomes of colostomy
No postoperative mortality
Surgical revision because of partial prolapse of the colostomy: 9 % (1/11)
Mean hospital stay: 8 days (range 7 – 10 days)
Median survival: 280 days (135 – 591 days)
Late complications:
|
Moderate
|
|
Xinopoulos,
2004 [128]
|
RCT
|
Palliative Wallstent colonic stent placement versus colostomy
|
Patients with inoperable malignant partial obstruction in the left colon originating from colorectal or ovarian cancer (n = 30)
Palliative SEMS placement (n = 15),
Colostomy (n = 15)
|
Efficacy, safety, cost-effectiveness
|
Outcomes of SEMS placement
Technical success rate: 93.3 %
Moderate tumor ingrowth: 43 % (6/14), treated with Diomed laser, without reoccurrence of obstructive symptoms
Stent migration: 7 % (1/14)
SEMS versus colostomy
Total hospital stay: 28 vs. 60 days
Median survival: 21.4 vs. 20.9 weeks (P = n.s.)
Average total cost: € 2224 vs. € 2092 (P = n.s.)
|
Moderate
|
Table e4 b (a – d)
Palliative SEMS placement. (b) Systematic reviews and meta-analyses on palliative SEMS placement.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Liang,
2014 [104]
|
Meta-analysis
|
SEMS versus surgery for palliative treatment of colorectal obstruction caused by advanced colorectal malignancy
|
Patients with malignant colorectal obstruction caused by advanced malignancy
3 RCTs
2 Prospective
4 Retrospective
Palliative SEMS placement (n = 195),
Emergency surgery (n = 215)
|
Short-term and long-term complications, mortality, and time of hospitalization
|
Major stent-related complications:
-
Short-term (< 30 days) perforation rate: 3.7 %
-
Long-term (≥ 30 days) perforation rate: 7.6 %
-
Overall stent migration rate: 8.9 %
-
Re-obstruction: not analyzed.
Successful relief of obstruction:
-
Palliative SEMS: 94 %
-
Surgery: 100 %
Short-term (< 30 days) complication rate (P = 0.22):
Long-term (≥ 30 days) complication rate (P = 0.03):
Overall complication rate (P = 0.56):
Overall mortality rate (P = 0.22):
SEMS required significantly shorter hospitalization: weighted mean difference – 6.07 days (95 %CL – 8.40, – 3.74); P < 0.01
|
High
|
|
Zhao,
2013 [105]
|
Meta-analysis
|
Palliative stent placement vs. palliative surgical decompression
|
Patients with malignant colorectal obstruction that was unresectable
3 RCTs
5 Prospective
4 Retrospective
1 Case-matched
Palliative SEMS placement (n = 404),
Palliative surgery (n = 433)
|
Hospital stay, intensive care unit admission, clinical success rate, 30-day mortality, stoma formation, complications and overall survival time
|
Mean length of hospital stay (P < 0.001):
ICU admission rate (P = 0.001):
Mean interval to chemotherapy:
Clinical relief of obstruction (P < 0.001):
-
Palliative SEMS: 93.1 % (375/403)
-
Surgery: 99.8 % (433/434)
-
R 0.96 (95 %CI 0.93 – 0.98); I
2 = 3 %
In-hospital mortality rate (P = 0.01):
Overall complication rate (P = 0.60):
-
Palliative SEMS: 34.0 % (137/403)
-
Surgery: 38.1 % (172/452)
-
RR 0.91 (95 %CI 0.64 – 1.29); I
2 = 66 %
Early complication rate (P = 0.03):
-
Palliative SEMS: 13.7 % (41/300)
-
Surgery: 33.7 % (110/326)
-
RR 0.45 (95 %CI 0.22 – 0.92); I
2 = 66 %
Late complication rate (P < 0.001):
Stent complications:
Overall survival time (P = n.s.):
Stoma formation rate (P < 0.001):
-
Palliative SEMS: 12.7 % (38/299)
-
Surgery: 54.0 % (170/315)
-
RR 0.26 (95 %CI 0.18 – 0.37); I
2 = 18 %
|
High
|
Table e4 c (a – d)
Palliative SEMS placement. (c) Other literature on palliative SEMS placement.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Abbott,
2014 [11]
|
Retrospective
|
Palliative endoscopic SEMS insertion
Wallstent,
Taewoong,
Schneider
|
Patients with colonic obstruction due to colorectal cancer or metastatic extracolonic disease (n = 146)
|
Technical success and complication rates of SEMS, and identifying any predictors of stent-related complications and re-intervention
|
Technical success rate: 97.3 %
Clinical success rate: 95.8 %
Early complication rate: 13.0 %
Late complication rate: 26.7 %
Overall complication rate: 39.7 %
30-day procedural mortality rate: 2.7 %
Overall re-intervention rate: 30.8 %
-
Endoscopic: 18.5 %
-
Surgical: 14.4 %
Median post-procedure length of hospital stay: 2 days
Median survival: 9.2 months (95 %CI 8.2 – 10.2)
Stoma rate: 11.0 %
|
Low
|
|
Gianotti,
2013 [109]
|
Prospective
|
Preoperative SEMS placement, palliative SEMS placement or emergency surgery
Hanarostent
|
Patients with colorectal obstruction
Malignant (n = 121),
Benign (n = 11)
Preoperative SEMS placement (n = 49),
Palliative SEMS placement (n = 32),
Emergency surgery (n = 51)
|
Short-term and long-term outcomes of different treatment modalities
|
Overall technical success rate of stenting: 95.3 %
Overall clinical success rate of stenting: 98.8 %
Median interval to elective surgery: 6 (2 – 20) days
Short-term stent complications: 14.1 %
Long-term outcome of SEMS (n = 32)
Clinical success rate: 81.2 %
Overall long-term complication rate: 43.8 %
Hospital readmission: 34.4 %
Median survival (n = 29): 10 months (95 %CI 4 – 16)
|
Moderate
|
|
Huhtinen,
2013 [111]
|
Retrospective
|
Palliative SEMS insertion
Ultraflex,
Hanarostent
|
Patients with obstructive incurable colorectal cancer (n = 56)
|
Clinical outcomes of SEMS and factors associated with late complications
|
Technical and clinical success rate: 75 % and 70 % (39/56)
Overall complication rate: 38 % (16/42)
-
Perforation: 10 %
-
Re-obstruction: 14 %
-
Incontinence: 5 %
-
Pain: 5 %
-
Stent migration: 2 %
Stent-related mortality: 7 %
Late complications: 31 %
Re-intervention rate: 24 %
-
Ostomy (n = 8)
-
Hartmann (n = 1)
-
Re-stenting (n = 1)
|
Low
|
|
Yoshida,
2013 [110]
|
Prospective feasibility study
|
Palliative Niti-S D-type uncovered stent insertion
|
Patients with malignant large-bowel obstruction (n = 33)
|
Efficacy and safety of the new uncovered Niti-S D-type stent
|
Technical success rate: 100 %
Clinical success rate: 97 %
Median follow-up: 126 days (range 20 – 750)
Early complications:
Late complications:
-
Stent occlusion: 30 %
-
Stent migration: 3 %
-
Bleeding: 9 %
-
Tenesmus: 3 %
Re-interventions:
-
Colostomy: 3 % (1/33)
-
Endoscopic: 27 % (9/33)
Mean survival: 240 days
|
Low
|
|
Angenete,
2012 [112]
|
Prospective stent cohort and retrospective control group
|
Colorectal SEMS placement or emergency surgery
|
Patients with colonic obstruction due to rectal or colon cancer
Palliative SEMS placement (n = 88),
SEMS as bridge to surgery (n = 24),
Control group (n = 60)
|
Morbidity, mortality and hospital stay
|
Overall technical success rate of SEMS: 96 %
Overall clinical success rate of SEMS: 90 %
Overall stent complications:
-
Stent migration: 5.4 %
-
Perforation: 5.4 %
-
Fistula: 2.7 %
-
Bleeding: 1.8 %
-
Sepsis: 0.9 %
-
Other: 4.5 %
-
Cardiopulmonary: 1.8 %
Re-stenting: 10 %
Outcomes in palliative SEMS group
Surgery due to complications: 18 %
-
Poor technical success: 5 %
-
Poor clinical success: 5 %
-
Fistula: 2 %
-
Perforation: 5 %
-
Palliative resection: 2 %
Stoma formation: 8 % (7/88) compared with 53 % (32/60) in the surgery group
|
Low
|
|
Meisner,
2012 [113]
|
Prospective
|
WallFlex uncovered colonic stent placement
|
Patients with colorectal strictures secondary to malignant disease undergoing palliative stent placement (n = 255)
|
Procedural and clinical success, safety
|
Procedural success rate: 98.4 %
Follow-up visits and clinical success:
-
30 days (n = 206): 87.8 %
-
3 months (n = 126): 89.7 %
-
6 months (n = 86): 92.8 %
-
12 months (n = 36): 96 %
Overall perforation rate: 5.1 % (13/255)
Overall stent migration rate: 5.5 % (14/255)
Cumulative complications:
-
Perforation rate: 13.8 % (13/94)
-
Stent migration: 12.8 % (12/94)
-
Tumor ingrowth/overgrowth: 17.0 % (16/94)
-
Fecal impaction: 8.5 % (8/94)
-
Second colonic obstruction: 2.1 % (2/94)
-
Bleeding: 4.3 % (4/94)
-
Pain: 4.3 % (4/94)
-
Persistent obstruction: 1.1 % (1/94)
12-month mortality rate: 48.6 %
Stent-related mortality: 0.8 %
|
Moderate
|
|
Manes,
2011 [55]
|
Retrospective
|
Colonic stent placement
WallFlex,
Wallstent,
Ultraflex,
Hanarostent,
Bonastent,
Evolution
|
Patients with incurable malignant colonic obstruction (n = 201)
|
Short-term and long-term efficacy of SEMS
|
Technical success rate: 91.5 %
Immediate clinical success rate: 89.7 %
Mean follow-up: 115 days (1 – 500 days)
Sustained relief of obstruction until death: 77.0 % (127/165)
Stent patency at 6 and 12 months: 82.1 % and 65.7 %
Overall major complications: 11.9 %
Permanent colostomy (n = 9)
|
Low
|
|
Young,
2011 [122]
|
Prospective
|
Colonic SEMS insertion
Wallstent,
Ultraflex,
WallFlex
|
Patients having an attempted SEMS insertion for large-bowel obstruction (n = 100)
Palliative SEMS placement (n = 89),
Preoperative SEMS placement (n = 11)
Malignant obstruction (n = 93),
Benign obstruction (n = 7)
|
Stent patency, morbidity and mortality
|
Median follow-up: 34.5 (1 – 64) months
Median survival: 4 (95 %CI 3.2 – 4.9) months
Technical success rate: 87 %
48-hour clinical success rate: 84 %
72 patients were considered to have avoided a stoma
30-day mortality: 7 %
Stent-related morbidity: 20 %
-
Perforation: 5 %
-
Dislodgement: 4 %
-
Migration: 1 %
-
Obstruction: 5 %
-
Pain: 4 %
-
Incontinence: 1 %
-
Impaction: 1 %
Patent stent at last follow-up or death: 73 %
|
Moderate
|
Table e4 d (a – d)
Palliative SEMS placement. (d) Outcomes of palliative SEMS placement during chemotherapy and antiangiogenic therapy.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Abbott,
2014 [11]
|
Retrospective
|
Palliative endoscopic SEMS insertion
Wallstent,
Taewoong,
Schneider
|
Patients with colonic obstruction due to colorectal cancer or metastatic extracolonic disease (n = 146)
Chemotherapy (n = 58)
|
Technical success and complication rates of SEMS, and identifying any predictors of stent-related complications and re-intervention
|
Technical success rate: 97.3 %
Clinical success rate: 95.8 %
Overall complication rate: 39.7 %
Overall reintervention rate: 30.8 %
-
Endoscopic: 18.5 %
-
Surgical: 14.4 %
Predictors of early complications:
Predictors of late complications:
Predictors of endoscopic reintervention:
Predictors of surgical treatment:
|
Low
|
|
Di Mitri,
2014 [117]
|
Retrospective
|
Colorectal SEMS placement
WallFlex,
Evolution,
Ultraflex
|
Patients with obstructive colorectal cancer (n = 204)
Palliative SEMS placement (n = 143),
SEMS as bridge to surgery (n = 61)
Chemotherapy (n = 105)
|
Technical success, clinical efficacy, complications
|
Technical success rate: 99.0 %
Clinical success rate: 94.6 %
Median follow-up: 6 months (range 1 – 32)
Overall complications: 15.2 %
-
Tumor ingrowth: 8.3 %
-
Stent migration: 4.9 %
-
Perforation: 2.0 %
“None of the perforation cases were on bevacizumab”
Survival at end of follow-up: 46.1 %
Univariable analysis of risk factors associated with complications:
Univariable analysis of risk factors associated with death:
Univariable analysis of risk factors associated with tumor ingrowth:
Multivariable analysis of risk factors associated with tumor ingrowth:
|
Low
|
|
Van Halsema,
2014 [51]
|
Meta-analysis
|
Colorectal SEMS placement
|
All patients who underwent colorectal stent placement (n = 4086)
|
Risk factors for perforation from colonic stenting
|
Pooled perforation rate for:
Patients without concomitant therapy:
Patients treated with chemotherapy:
Patients treated with bevacizumab:
|
Moderate
|
|
Canena,
2012 [119]
|
Retrospective
|
Palliative colorectal SEMS placement
WallFlex,
Wallstent,
Ultraflex
|
Patients with inoperable malignant colorectal obstruction (n = 89)
Chemotherapy (n = 24)
|
Long-term clinical efficacy and factors affecting stent patency, clinical success, and complications
|
Univariate analysis of factors associated with long-term clinical success:
Chemotherapy (P = 0.45):
-
Yes: 70.8 % (17/24)
-
No: 78.5 % (51/65)
Multivariate logistic analysis of risk factors for stent migration:
Multivariate logistic analysis of risk factors for obstruction:
Multivariate Cox regression analysis of factors associated with stent patency:
|
Low
|
|
Lee HJ,
2011 [118]
|
Retrospective
|
Colorectal SEMS placement or surgery
WallFlex,
Comvi stent,
Niti-S D-type
|
Patients with metastatic unresectable colorectal cancer with imminent obstruction
Palliative SEMS placement (n = 71),
Emergency surgery (n = 73)
|
Long-term outcomes of endoscopic stenting and surgery
|
Risk factors for late complications:
Chemotherapy (P = 0.003):
-
Yes: 47.8 % (22/46)
-
No: 10 % (2/20)
Bevacizumab (P = 0.645):
-
Yes: 20 % (1/5)
-
No: 37.7 % (23/61)
Palliative chemotherapy was not significantly associated with perforation
Multivariate analysis of risk factors for late complications:
Prognostic factors for overall survival:
Chemotherapy (P < 0.001):
-
Yes: 15.1 months
-
No: 4.5 months
Target agent (P = 0.020):
-
Yes: 18.4 months
-
No: 9.6 months
Multivariate analysis of factors associated with survival:
|
Low
|
|
Luigiano,
2011 [76]
|
Prospective
|
Endoscopic WallFlex placement for palliation
|
Patients with malignant colorectal obstruction (n = 39)
Chemotherapy (n = 13)
|
Outcomes of through-the-scope large-diameter SEMS placement for palliation
|
Technical success rate: 92.3 %
Clinical success rate: 89.7 %
Early complications:
-
Perforation: 5.6 %
-
Bleeding: 2.8 %
Late complications:
Overall median survival: 280 days (range 32 – 511)
No correlation between chemotherapy and late complications (P = 0.120)
Palliative chemotherapy was associated with longer survival (P = 0.006)
|
Low
|
|
Manes,
2011 [55]
|
Retrospective
|
Colonic stent placement
WallFlex,
Wallstent,
Ultraflex,
Hanarostent,
Bonastent,
Evolution
|
Patients with incurable malignant colonic obstruction (n = 201)
Chemotherapy (n = 74),
Bevacizumab (n = 8)
|
Short-term and long-term efficacy of SEMS
|
Overall chemotherapy did not increase the risk of complications
Perforation risk for bevacizumab (P < 0.001):
|
Low
|
|
Yoon,
2011 [8]
|
Retrospective
|
Colorectal SEMS insertion
Niti-S covered,
Comvi stent,
WallFlex,
Niti-S D-type
|
Patients with malignant colorectal obstruction (n = 412)
|
Rates and factors predictive of technical and clinical failure of SEMS
|
Long-term clinical failure: 36.3 % (73/201)
Multivariate analysis of risk factors for long-term clinical failure in palliation group:
|
Low
|
|
Fernandez-Esparrach,
2010 [120]
|
Retrospective
|
Colorectal SEMS insertion
Wallstent,
WallFlex,
Hanarostent
|
Patients with colorectal cancer of the left colon with obstructive symptoms (n = 47)
Chemotherapy (n = 28)
|
Long-term clinical success and factors predictive of development of complications
|
Technical success rate: 94 %
Clinical success rate: 94 %
Overall complication rate: 51 %
-
Stent migration: 22 %
-
Perforation: 7 %
-
Re-obstruction: 17 %
-
Tenesmus: 5 %
Complication-related death: 12 %
Long-term complication rate for chemotherapy vs. no chemotherapy: 62 % (16/26) vs. 33 % (5/15); P = 0.082
“8/9 patients with stent migration and 2/3 patients with perforation had been treated with chemotherapy”
|
Low
|
|
Small,
2010 [15]
|
Retrospective
|
Colonic SEMS placement
Ultraflex,
Wallstent,
WallFlex
|
Patients with malignant colorectal obstruction (n = 233)
|
Long-term efficacy, incidence of complications, and risk factors of SEMS placement
|
Univariate analysis of risk factors for major complications:
Palliative chemotherapy (P = 0.054):
-
Yes: 29.8 % (25/84)
-
No: 19.0 % (16/84)
Bevacizumab therapy (P = 0.107):
-
Yes: 34.8 % (8/23)
-
No: 22.8 % (33/145)
Univariate analysis of risk factors for perforation:
Bevacizumab (P = 0.064):
-
Yes: 17.4 % (4/23)
-
No: 7.6 % (11/145)
|
Low
|
|
Cennamo,
2009 [116]
|
Case series
|
WallFlex colonic stent placement
|
Patients with occlusive colon cancer (n = 28)
SEMS as bridge to surgery (n = 12)
Chemotherapy (n = 9),
Bevacizumab (n = 2)
|
Perforation risk after bevacizumab therapy
|
Median follow-up: 131 days
Delayed colonic perforation occurred in the 2 patients treated with a combination of capecitabine and oxaliplatin plus bevacizumab
|
Low
|
|
Kim JH,
2009 [43]
|
Prospective nonrandomized
|
Radiologic dual-design SEMS insertion
Flared ends (n = 69),
Bent ends (n = 53)
|
Patients with malignant colorectal obstruction (n = 122)
|
Clinical safety and efficacy of dual-design stents
|
Flared-ends versus bent-ends
Technical success rate: 94.2 % vs. 96.2 %
Clinical success rate: 93.8 % vs. 90.2 %
Overall complication rate: 18.5 % vs. 25.5 %
Perforation rate: 6.2 % vs. 5.9 %
Stent migration rate: 6.2 % vs. 5.9 %
Stent migration was significantly related to chemotherapy (P = 0.029)
|
Moderate
|
CI, confidence interval; CL, confidence limits; HR, hazard ratio; ICU, intensive care unit; n.s., not significant; OR, odds ratio; RCT, randomized controlled trial; RR, relative risk SEMS, self-expandable metal stent.
Table e5 a
(a, b)
Adverse events related to colonic stenting (a) Adverse events.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Abbott,
2014 [11]
|
Retrospective
|
Palliative endoscopic SEMS insertion
Wallstent,
Taewoong,
Schneider
|
Patients with colonic obstruction due to colorectal cancer or metastatic extracolonic disease (n = 146)
|
Technical success and complication rates of SEMS, and identifying any predictors of stent-related complications and re-intervention
|
Technical success rate: 97.3 %
Clinical success rate: 95.8 %
Median post procedure length of hospital stay: 2 days
Early complication rate: 13.0 %
Late complication rate: 26.7 %
30-day procedural mortality rate: 2.7 %
Overall re-intervention rate: 30.8 %
-
Endoscopic: 18.5 %
-
Surgical: 14.4 %
Median time to endoscopic reintervention: 4.6 months
4/27 patients required surgical treatment within 30 days of insertion of a second SEMS
Median survival: 9.2 months (95 %CI 8.2 – 10.2)
Stoma rate: 11.0 %
|
Low
|
|
Di Mitri,
2014 [117]
|
Retrospective
|
Colorectal SEMS placement
WallFlex,
Evolution,
Ultraflex
|
Patients with obstructive colorectal cancer (n = 204)
|
Technical success, clinical efficacy, complications
|
Technical and clinical success rate: 99.0 % and 94.6 %
Median follow-up: 6 months (range 1 – 32)
Overall complication rate: 15.2 %
-
Tumor ingrowth: 8.3 %
-
Stent migration: 4.9 %
-
Perforation: 2.0 %
Early (≤ 30 days) complications: 3.9 %
-
Perforation: 1.9 %
-
Stent migration: 1.5 %
-
Stent ingrowths: 0.5 %
Late (> 30 days) complications: 11.2 %
-
Stent migration 3.4 %
-
Tumor ingrowths 7.8 %
SEMS migration or neoplastic ingrowths were treated with a second stent
Overall clinical benefit at end of follow-up: 79.4 %
Survival at end of follow-up: 46.1 %
|
Low
|
|
Geraghty,
2014 [16]
|
Retrospective
|
Colonic stenting for large-bowel obstruction
|
Patients in whom SEMS placement was attempted for large-bowel obstruction (n = 334)
-
CRC palliation (n = 264),
-
CRC bridge to surgery (n = 52),
-
Benign (n = 9),
-
Extrinsic (n = 9)
|
Outcome of colonic stenting and factors associated with successful intervention
|
Overall technical success rate: 87.4 %
Overall clinical success rate: 83.5 %
Technical failure:
-
Inability to deploy SEMS: 6.0 %
-
Perforation: 2.7 %
-
Stent migration: 2.1 %
-
Insufficient expansion: 1.2 %
-
Incorrect stent positioning: 0.6 %
-
Peri-interventional cardiorespiratory episode: 1.2 %
Additional complications:
Re-stenting for migration or tumor overgrowth: 7.5 %
Surgical re-intervention: 10.8 %
30-day mortality: 13.2 %
|
Low
|
|
Gianotti,
2013 [109]
|
Prospective
|
Preoperative SEMS placement, palliative SEMS placement or emergency surgery
Hanarostent
|
Patients with colorectal obstruction
Malignant (n = 121),
Benign (n = 11)
Preoperative SEMS placement (n = 49),
Palliative SEMS placement (n = 32),
Emergency surgery (n = 51)
|
Short-term and long-term outcomes of different treatment modalities
|
Overall technical success rate of SEMS: 95.3 %
Overall clinical success rate of SEMS: 98.8 %
Overall early (< 30 days) complications: 14.8 %
Long-term outcome of SEMS (n = 32)
Clinically successful: 81.2 %
Overall long-term complications: 43.8 %
Treatment of complications:
Stent migration: SEMS was immediately replaced successfully
Stool impaction: endoscopically guided colon irrigation
Tumor ingrowth: stent-in-stent
Colorectal bleeding: short-term bleeding did not require endoscopic hemostasis or blood transfusion, while late bleeding required endoscopic hemostasis (n = 1) and blood transfusion (n = 3)
Hospital re-admission rate: 34.4 %
Median survival (n = 29): 10 months (95 %CI 4 – 16)
|
Moderate
|
|
Zhao,
2013 [105]
|
Meta-analysis
|
Palliative stent placement vs. palliative surgical decompression
|
Patients with malignant colorectal obstruction that was unresectable
3 RCTs
5 Prospective
4 Retrospective
1 Case-matched
Palliative SEMS placement (n = 404),
Palliative surgery (n = 433)
|
Hospital stay, intensive care unit admission, clinical success rate, 30-day mortality, stoma formation, complications, and overall survival time
|
Stent complications:
Outcomes of palliative SEMS for subgroup of patients with colorectal cancer obstructions (n = 370):
-
30-day mortality rate: 3.8 %
-
Early complication rate: 11.2 %
-
Total complication rate: 32.1 %
|
High
|
|
Angenete,
2012 [112]
|
Prospective stent cohort and retrospective control group
|
Colorectal SEMS placement or emergency surgery
|
Patients with colonic obstruction due to rectal or colon cancer
Palliative SEMS placement (n = 88),
SEMS as bridge to surgery (n = 24),
Control group (n = 60)
|
Morbidity, mortality, and hospital stay
|
Overall technical success rate: 96 %
Overall clinical success rate: 90 %
Overall stent complications:
-
Stent migration: 5.4 %
-
Perforation: 5.4 %
-
Fistula: 2.7 %
-
Bleeding: 1.8 %
-
Sepsis: 0.9 %
-
Other: 4.5 %
-
Cardiopulmonary: 1.8 %
Stent-related 30-day mortality: 7 %
Re-stenting: 10 %
All cases of re-stenting were technically and clinically successful
Outcome in palliative SEMS group
Surgery due to complications: 18 %
-
Poor technical success: 5 %
-
Poor clinical success: 5 %
-
Fistula: 2 %
-
Perforation: 5 %
-
Palliative resection: 2 %
Stoma formation: 8 % (7/88)
|
Low
|
|
Cheung,
2012 [58]
|
RCT
|
Colonic SEMS placement
Taewoong D-type uncovered stent (n = 52),
Boston Scientific WallFlex stent (n = 71)
|
Patients with acute malignant colonic obstruction
Palliative SEMS placement (n = 58),
SEMS as bridge to surgery (n = 65)
|
Clinical outcome and safety of the D-type stent and the WallFlex stent
|
WallFlex versus Taewoong D-Type
Outcomes in palliation group:
Technical success rate: 100 % vs. 100 %
Clinical success rate: 100 % vs. 100 %
Perforation rate: 3.6 % vs. 0 %
Migration rate: 3.6 % vs. 3.3 %
Re-stenosis rate: 3.6 % vs. 0 %
Median stent patency:
|
Moderate
|
|
Meisner,
2012 [113]
|
Prospective
|
WallFlex uncovered colonic stent placement
|
Patients with colorectal strictures secondary to malignant disease undergoing palliative stent placement (n = 255)
|
Procedural and clinical success, safety
|
Procedural success rate: 98.4 %
Follow-up visits and clinical success:
-
30 days (n = 206): 87.8 %
-
3 months (n = 126): 89.7 %
-
6 months (n = 86): 92.8 %
-
12 months (n = 36): 96 %
Overall perforation rate: 5.1 % (13/255)
Overall stent migration rate: 5.5 % (14/255)
Cumulative complications:
-
Perforation rate: 13.8 % (13/94)
-
Stent migration: 12.8 % (12/94)
-
Tumor ingrowth/overgrowth: 17.0 % (16/94)
-
Fecal impaction: 8.5 % (8/94)
-
Second colonic obstruction: 2.1 % (2/94)
-
Bleeding: 4.3 % (4/94)
-
Pain: 4.3 % (4/94)
-
Persistent obstruction: 1.1 % (1/94)
12-month mortality rate: 48.6 %
Stent-related mortality: 0.8 %
|
Moderate
|
|
de Gregorio,
2011 [48]
|
Retrospective
|
Colorectal stent placement
Wallstent,
SX-ELLA intestinal stent
|
Patients with total or partial large-bowel obstruction secondary to malignancy (n = 467)
|
Procedure time, radiation dose, technical success, clinical success
|
Technical success rate: 92.5 %
Clinical success rate: 88.2 %
Overall complication rate: 19 %
30-day mortality rate in bridge-to-surgery group: 4.3 %
Mean follow-up in palliation group: 15.6 months
Primary stent patency without complications: 52.9 %
Mean survival in palliation group: 234 days
|
Low
|
|
Manes,
2011 [55]
|
Retrospective
|
Colonic stent placement
WallFlex,
Wallstent,
Ultraflex,
Hanarostent,
Bonastent,
Evolution
|
Patients with incurable malignant colonic obstruction (n = 201)
|
Short-term and long-term efficacy of SEMS
|
Technical success rate: 91.5 %
Immediate clinical success rate: 89.7 %
Technical failures:
Early stent failure
-
Early migration: 3.3 % (6/184)
-
Stent malposition: 7.1 % (13/184)
-
Early perforation: 1.1 % (2/184)
Mean follow-up: 115 days (1 – 500 days)
Sustained relief of obstruction until death: 77.0 % (127/165)
Stent patency at 6 and 12 months: 82.1 % and 65.7 %
Overall major complication rate: 11.9 %
|
Low
|
|
Meisner,
2011 [12]
|
Prospective cohort
|
WallFlex Colonic stent placement
|
Patients with malignant colonic obstruction (n = 463)
-
Palliative SEMS placement (n = 255),
-
SEMS as bridge to surgery (n = 182),
-
Indication not specified (n = 10)
|
Performance, safety, and effectiveness of colorectal stents
|
Overall procedural success rate: 94.8 %
-
No stent could be placed: 3.5 %
-
Poor stent position: 1.1 %
-
Inability of stent to deploy: 0.2 %
-
Perforation: 0.4 %
25 % of patients were not eligible for 30-day clinical success evaluation
Intention-to-treat 30-day clinical success rate: 71.6 %
Per-protocol 30-days clinical success rate: 90.5 %
30-days mortality rate: 8.9 %
30-days cumulative adverse events:
-
Fecal impaction: 1.6 %
-
Mucosal/bowel impaction into stent: 0.5 %
-
Second colonic obstruction: 0.3 %
-
Bleeding: 0.5 %
-
Perforation: 3.9 %
-
Stent migration: 1.8 %
-
Pain: 1.8 %
-
Persistent obstruction: 0.8 %
|
Moderate
|
|
Park JK,
2011 [59]
|
Retrospective
|
Through-the-scope palliative SEMS insertion
Uncovered:
Wallstent,
Niti-S,
Bonastent,
Hanarostent
Covered:
Niti-S,
Bonastent
|
Patients with incurable malignant colorectal obstruction (n = 103)
-
Uncovered SEMS (n = 73),
-
Covered SEMS (n = 30)
|
Success rates and complication rates according to stent type
|
Uncovered versus covered SEMS
Technical success rate: 100 % vs. 100 %
Clinical success rate: 100 % vs. 97 %
Overall complication rate: 26 % vs. 20 %
Stent patency up to death: 74 % vs. 80 %
Median stent patency:
|
Low
|
|
Van Hooft,
2011 [31]
|
RCT
|
Colonic stenting as a bridge to elective surgery compared with emergency surgery
Wallstent,
WallFlex
|
Patients with acute left-sided colorectal obstruction
SEMS as bridge to surgery (n = 47),
Emergency surgery (n = 51)
|
Mean global health status, mortality, morbidity, other quality-of-life dimensions, and stoma rate
|
Outcomes of SEMS placement
Technical success rate: 70.2 %
Clinical success rate: 70.2 %
Perforation rate: 12.8 %
Bridge to elective surgery: 93.9 % (31/33)
Successful primary anastomosis: 48.4 %
Operative specimens showed 3 silent perforations
|
Moderate
|
|
Yoon,
2011 [8]
|
Retrospective
|
Colorectal SEMS insertion
Niti-S covered,
Comvi stent,
WallFlex,
Niti-S D-type
|
Patients with malignant colorectal obstruction (n = 412)
|
Rates and factors predictive of technical and clinical failure of SEMS
|
Palliation group:
Bridge-to-surgery group:
Overall technical failure: 9.5 % (39/412)
-
Inability to pass guidewire: 7.3 %
-
Technical difficulty because of colonic immobilization and severe pain: 1.9 %
-
Nonexpansion of SEMS: 0.2 %
Immediate clinical failure in palliation group: 16.3 % (39/240)
Long-term clinical failure: 36.3 % (73/201)
Median duration to long-term clinical failure: 287 days (range 4 – 507)
|
Low
|
|
Young,
2011 [122]
|
Prospective
|
Colonic SEMS insertion
Wallstent,
Ultraflex,
WallFlex
|
Patients having an attempted SEMS insertion for large-bowel obstruction (n = 100)
-
Palliative SEMS placement (n = 89,
-
Preoperative SEMS placement (n = 11)
-
Malignant obstruction (n = 93)
-
Benign obstruction (n = 7)
|
Stent patency, morbidity, and mortality
|
Median follow-up: 34.5 months (range 1 – 64)
Median survival: 4 months (95 %CI 3.2 – 4.9)
Technical success rate: 87 %
Patency rate:
-
48-hour: 84 %
-
30-day: 76 %
30-day mortality rate: 7 %
Overall stent-related morbidity rate: 20 %
Early (< 30 days) complications:
-
Perforation: 4 %
-
Dislodgement: 4 %
-
Migration: 0 %
-
Obstruction: 2 %
-
Pain: 4 %
-
Incontinence: 1 %
-
Impaction: 0 %
Late (> 30 days) complications:
-
Perforation: 1 %
-
Dislodgement: 0 %
-
Migration: 1 %
-
Obstruction: 3 %
-
Pain: 1 %
-
Incontinence: 1 %
-
Impaction: 1 %
Patent stent at last follow-up or death: 73 %
|
Moderate
|
|
Van Hooft,
2008 [123]
|
RCT
|
Through-the-scope WallFlex colorectal stent insertion versus emergency surgery
|
Patients with incurable stage IV left-sided colorectal cancer
Palliative SEMS placement (n = 11),
Emergency surgery (n = 10)
|
Survival in good health out of hospital
|
Outcomes of palliative SEMS:
Technical success: 9/10
Early complications (< 30 days):
-
Perforation (n = 2)
-
Severe diarrhea (n = 1)
-
Severe pain (n = 1)
30-day mortality: 2/10
Late (> 30 days) complications:
-
Perforation (n = 4)
-
Fecal impaction (n = 1)
-
Tumor ingrowth (n = 1)
-
Stent migration (n = 1)
|
Moderate
|
|
Watt,
2007 [121]
|
Systematic review
|
Colorectal SEMS placement compared with surgical procedures
|
Patients with malignant colorectal obstruction
88 articles, of which 15 comparative
Palliative SEMS placement (n = 762),
SEMS as bridge to surgery (n = 363),
Clinical pathway not clear (n = 660)
|
Efficacy and safety of SEMS
|
Median rate of technical success: 96.2 % (range 66.6 % – 100 %)
Median rate of clinical success: 92 % (range 46 % – 100 %)
Median stent patency: 106 days (range 68 – 288)
Overall, 90.7 % (118/130) of patients either died or ended follow-up with a patent stent
Median stent migration rate: 11 % (range 0 % – 50 %)
Median perforation rate: 4.5 % (range 0 % – 83 %)
Median re-obstruction rate: 12 % (range 1 % – 92 %
|
Moderate
|
Table e5 b (a, b)
Adverse events related to colonic stenting. (b) Outcomes of secondary placement of self-expandable metal stent (SEMS) after initial stent failure.
|
First author, year
|
Study design
|
Intervention
|
Participants
|
Outcomes
|
Results
|
Level of evidence
|
|
Yoon,
2013 [114]
|
Retrospective
|
SEMS reinsertion or palliative surgery
Niti-S covered,
Comvi covered,
WallFlex uncovered,
Niti-S D-type uncovered
|
Patients who underwent palliative SEMS insertion for the treatment of malignant colorectal obstruction, and had recurrence of obstructive symptoms for various reasons and required secondary interventions
SEMS reinsertion (n = 79),
Palliative surgery (n = 57)
|
Overall survival, progression-free survival, and luminal patency
|
Secondary SEMS outcomes
Technical success rate: 97.5 %
Clinical success rate: 86.1 %
Median follow-up: 142 days
Immediate complications: 13.9 %
-
Migration (n = 8)
-
Perforation (n = 2)
-
Severe bleeding (n = 1)
Late complications: 15.2 %
-
Migration (n = 8)
-
Perforation (n = 4)
No SEMS-related mortality
SEMS (n = 58) versus surgery
Median overall survival: 8.2 vs. 15.5 months (P = 0.895)
12-month survival: 42.1 % vs. 46.3 %
Median progression-free survival: 4.0 vs. 2.7 months (P = 0.650)
Median luminal patency: 3.4 vs. 7.9 months (P = 0.003)
Immediate complications: 13.9 % vs. 1.8 %
Late complications: 15.2 % vs. 1.8 %
Immediate mortality: 0 % vs. 7 %
Late mortality: 0 % vs. 5.3 %
|
Low
|
|
Yoon,
2011 [115]
|
Retrospective
|
Secondary SEMS placement as stent-in-stent
Niti-S covered,
Comvi covered,
WallFlex uncovered,
Niti-S D-type uncovered
|
Patients who underwent secondary SEMS because of the recurrence of obstructive symptoms (n = 36)
|
Immediate and long-term clinical success and complications
|
Median duration of primary stent patency: 81 days
Immediate clinical success: 75 %
Long-term clinical failure: 51.9 %
-
Migration (n = 7)
-
Perforation (n = 4)
-
Tumor ingrowth (n = 3)
Median follow-up after clinical success: 105 days
At end of follow-up, 44.4 % remained free of obstruction symptoms until death
Palliative bypass surgery: 33.3 %
|
Low
|
n.s., not significant; RCT, randomized controlled trial.
