CC BY-NC-ND 4.0 · Endosc Int Open 2024; 12(10): E1143-E1149
DOI: 10.1055/a-2411-1814
Original article

Outcomes of lumen apposing metal stent placement in patients with surgically altered anatomy: Multicenter international experience

1   Gastrointestinal Endoscopy, Istituto Clinico Mater Domini Casa di Cura Privata SpA, Castellanza, Italy (Ringgold ID: RIN9348)
,
Daryl Ramai
2   Gastroenterology and Hepatology, University of Utah Health, Salt Lake City, United States (Ringgold ID: RIN14434)
,
3   Foundation of Interventional and Therapeutic Endoscopy, New Brunswick, United States
,
Amy Tyberg
4   Division of Gastroenterology, Hackensack Meridian Hospital, Hackensack, United States
,
Haroon Shahid
4   Division of Gastroenterology, Hackensack Meridian Hospital, Hackensack, United States
,
Avik Sarkar
4   Division of Gastroenterology, Hackensack Meridian Hospital, Hackensack, United States
,
5   Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, India (Ringgold ID: RIN29751)
,
Jahnvi Dhar
5   Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, India (Ringgold ID: RIN29751)
,
6   Gastroenterology and Hepatology, KU Leuven University Hospitals Leuven, Leuven, Belgium
,
Schalk Van der Merwe
7   Hepatology and GI Research Laboratory, Department of Immunology, University of Pretoria, Pretoria, South Africa
8   Department of Hepatology and Biliopancreatic Disease, KU Leuven, Leuven, Belgium
,
9   Gastroenterology, University of California San Francisco Medical Center at Parnassus, San Francisco, United States (Ringgold ID: RIN43166)
,
Hyun Ji
10   Gastroenterology, University of California San Francisco, San Francisco, United States (Ringgold ID: RIN8785)
,
Sun-Chuan Dai
11   Gastroenterology Division, University of California San Francisco Medical Center, San Francisco, United States
,
Pierre Deprez
12   Gastroenterology, Clin Univ St-Luc, Bruxelles, Belgium
,
Jorge Vargas-Madrigal
13   Gastroenterology Department, Enrique Baltodano Briceno Hospital, Liberia, Costa Rica, Costa Rica, Costa Rica
,
Giuseppe Vanella
14   Pancreato-BiliaryEndoscopy and Endosonography Division, Pancreas Translational & Clinical Research Center, San Raffaele Scientific Institute IRCCS, Vita-Salute San Raffaele University, Milan, Italy, Milan, Italy
,
Roberto Leone
15   Medicine, Vita-Salute San Raffaele University, Milano, Italy (Ringgold ID: RIN18985)
,
16   Gastroenterology and Gastrointestinal Endoscopy, Vita-Salute-San Raffaele University - IRCCS San Raffaele Hospital, Milan, Italy
,
17   Gastroenterology, Instituto Ecuatoriano de Enfermedades Digestivas - IECED, Guayaquil, Ecuador
18   Endoscopy, Omni Hospital, Guayaquil, Ecuador
,
Juan Alcivar Vasquez
17   Gastroenterology, Instituto Ecuatoriano de Enfermedades Digestivas - IECED, Guayaquil, Ecuador
,
19   IECED, Instituto Ecuatoriano de Enfermedades Digestivas, Guayaquil, Ecuador
,
Alessandro Fugazza
20   Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, Rozzano, Italy
,
Christopher Ko
2   Gastroenterology and Hepatology, University of Utah Health, Salt Lake City, United States (Ringgold ID: RIN14434)
,
John Morris
2   Gastroenterology and Hepatology, University of Utah Health, Salt Lake City, United States (Ringgold ID: RIN14434)
,
21   Gastroenterology Unit, Hospital of Imola, University of Bologna, Imola, Italy (Ringgold ID: RIN9296)
,
Pietro Fusaroli
21   Gastroenterology Unit, Hospital of Imola, University of Bologna, Imola, Italy (Ringgold ID: RIN9296)
,
Amaninder Dhaliwal
22   Division of Gastroenterology, University of Nebraska Medical Center, Omaha, United States (Ringgold ID: RIN12284)
,
Massimiliano Mutignani
23   Surgical Department, U.O.C. Digestive Endoscopy Unit, Milano, Italy
,
Edoardo Forti
24   Digestive Endoscopy, Ospedale Niguarda-Ca' Granda, Milan, Italy
,
Irene Cottone
24   Digestive Endoscopy, Ospedale Niguarda-Ca' Granda, Milan, Italy
,
Alberto Larghi
25   Digestive Endoscopy Unit, Universita' Cattolica del Sacro Cuore, Rome, Italy
,
Gianenrico Rizzatti
26   Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
,
27   Department of Medicine, Gastroenterology Unit, Hôpital Riviera-Chablais, Rennaz, Switzerland (Ringgold ID: RIN30919)
,
Carmelo Barbera
28   Gastroenterology and Digestive Endoscopy Unit, Nuovo Ospedale Civile S.Agostino-Estense, Baggiovara di Modena (Mo), Italy
29   Gastroenterology and Digestive Endoscopy Unit, Azienda Unita Sanitaria Locale di Modena, Italy (Ringgold ID: RIN18067)
,
Francesco Maria Di Matteo
30   Operative Endoscopy Department, Campus Bio-Medico University Hospital, Roma, Italy (Ringgold ID: RIN220431)
,
Serena Stigliano
31   Therapeutic GI Endoscopy Unit, Campus Bio-Medico University Hospital, Roma, Italy (Ringgold ID: RIN220431)
,
32   Unit of Gastroenterology and Digestive Endoscopy, Morgagni-Pierantoni Hospital, Forli, Italy (Ringgold ID: RIN18568)
33   Unit of Gastroenterology and Digestive Endoscopy, Maurizio Bufalini Hospital, Cesena, Italy (Ringgold ID: RIN161128)
,
Carlo Fabbri
34   Digestive Endoscopy and Gastroenterology Unit, Forlì-Cesena Hospitals, Azienda Unita Sanitaria Locale della Romagna, Forlì-Cesena, Italy (Ringgold ID: RIN390233)
,
Khanh Do-Cong Pham
35   Medicine, Haukeland University Hospital, Bergen, Norway
36   Clinical medicine, K1, University of Bergen, Bergen, Norway
,
Roberto Di Mitri
37   Gastroenterology and Endoscopy Unit, A.R.N.A.S. Civico-Di Cristina-Benfratelli Hospital, Palermo, Italy
,
38   Gastroenterology, IsMeTT/UPMC, Palermo, Italy
,
39   Gastroenterology and Digestive Endoscopy Unit, Pancreas Institute, University of Verona, Verona, Italy (Ringgold ID: RIN19051)
,
Andrew Ofosu
40   Gastroenterology and Hepatology, Brooklyn Hospital Center, Brooklyn, United States (Ringgold ID: RIN24508)
,
41   Gastroenterology and Digestive Endoscopy, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy (Ringgold ID: RIN18635)
,
42   Gastroenterology & Hepatology, King Fahad Medical City, Riyadh, Saudi Arabia (Ringgold ID: RIN37849)
,
Francesco Auriemma
43   Gastroenterologia, Università Federico II, Napoli, Italy
44   Digestive Endoscopy Unit, Division of Gastroenterology, Istituto Clinico Humanitas, Rozzano, Italy (Ringgold ID: RIN9268)
,
Danilo Paduano
45   Gastrointestinal Endoscopy Unit, Humanitas Mater Domini, Castellanza, Italy
,
Federica Calabrese
46   Gastrointestinal Endoscopy Unit, Humanitas Mater Domini, Castellanza, Varese, Italy
,
Carmine Gentile
46   Gastrointestinal Endoscopy Unit, Humanitas Mater Domini, Castellanza, Varese, Italy
,
47   Department of Biomedical Sciences, Humanitas University, Milan, Italy (Ringgold ID: RIN437807)
48   Endoscopy Unit, IRCCS Humanitas Clinical and Research Center, Milan, Italy
,
Alessandro Repici
49   Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy (Ringgold ID: RIN437807)
50   Digestive Endoscopy Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy (Ringgold ID: RIN9268)
,
51   Medical Sciences, Gastroenterology, Foggia, Italy
› Author Affiliations
 

Abstract

Background and study aims Although outcomes of lumen-apposing metal stents (LAMS) placement in native anatomy have been reported, data on LAMS placement in surgically altered anatomy (SAA) are sparse. We aimed to assess outcomes of LAMS placement in patients with SAA for different indications.

Patients and methods This was an international, multicenter, retrospective, observational study at 25 tertiary care centers through November 2023. Consecutive patients with SAA who underwent LAMS placement were included. The primary outcome was technical success defined as correct placement of LAMS. Secondary outcomes were clinical success and safety.

Results Two hundred and seventy patients (125 males; average age 61 ± 15 years) underwent LAMS placement with SAA. Procedures included EUS-directed transgastric ERCP (EDGE) and EUS-directed transenteric ERCP (EDEE) (n = 82), EUS-guided entero-enterostomy (n = 81), EUS-guided biliary drainage (n = 57), EUS-guided drainage of peri-pancreatic fluid collections (n = 48), and EUS-guided pancreaticogastrostomy (n = 2). Most cases utilized AXIOS stents (n = 255) compared with SPAXUS stents (n = 15). Overall, technical success was 98%, clinical success was 97%, and the adverse event (AE) rate was 12%. Using AGREE classification, five events were rated as Grade II, 21 events as Grade IIIa, and six events as IIIb. No difference in AEs were noted among stent types (P = 0.52).

Conclusions This study shows that placement of LAMS is associated with high technical and clinical success rates in patients with SAA. However, the rate of AEs is noteworthy, and thus, these procedures should be performed by expert endoscopists at tertiary centers.


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Introduction

The lumen apposing metal stent (LAMS) is a cutting-edge endoscopic device utilized for both benign and malignant conditions [1] [2]. Its unique "barbell" shape features flanged ends that provide a remarkably low risk of migration. While initially designed for draining pancreatic fluid collections (PFC) due to its larger inner lumen diameter compared with plastic stents or traditional self-expanding metal stents, it also enables endoscopes to access collections and conduct direct necrosectomy.

Numerous endoscopic ultrasound (EUS)-guided techniques have been described in recent years [2]. Notably, the deployment of LAMS through EUS guidance has enabled the treatment of a wider range of gastrointestinal conditions, including gastric outlet obstruction (GOO), drainage of fluid collections in the pancreas and other intraabdominal and pelvic areas, gallbladder drainage, and treatment of distal malignant biliary obstruction, among others [2] [3].

Recently, there has been a surge in use of LAMS to manage patients with surgically altered anatomy (SAA). These patients would have otherwise needed surgical or percutaneous interventions. The wide lumen design of LAMS allows easy access to the distant parts of the gastrointestinal tract that would have previously been difficult to reach [3]. As a result, minimally invasive interventions have gained immense popularity, with a growing body of literature [4] [5].

However, data are limited on outcomes following LAMS placement in SAA. To bridge this critical knowledge gap, we aimed to analyze a large cohort of patients who underwent LAMS placement in SAA for various indications.


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Patients and methods

Study design and population

Our study analyzed data from 25 international tertiary care centers, with 12 located in Italy, five in the United States, two in Belgium, and one each from Norway, Switzerland, Ecuador, Costa Rica, Saudi Arabia, and India. Consecutive patients with SAA underwent EUS-guided placement of LAMS through November 2023 for various indications, including malignant biliary obstruction, cholecystitis, drainage of peri-PFC, EUS-guided creation of enteric anastomoses, and EUS-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE). Demographic information, procedure-related details, and follow-up data were collected from electronic charts and telephone contacts. The study was approved by the institutional review board of Humanitas Mater Domini as well as individual contributing centers.


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Study outcomes, definitions, and statistical analysis

We considered technical success as the primary outcome, which meant successful placement of LAMS. We also measured clinical success by monitoring improvements in clinical parameters such as bilirubin level, white blood cell count, and ability to tolerate an oral diet. We categorized adverse events (AEs) as either early, occurring within 48 hours, or late, occurring after 48 hours. These events included bleeding, perforation, stent migration, mortality, and others. The AGREE classification was used to rate AEs [6]. Descriptive statistical analysis was performed using SPSS v27 (IBM, Armonk, New York, United States). A test of proportion (Z-test) was used to compare AE rates among stent types.


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Technique

Experienced operators performed all procedures under general anesthesia or propofol sedation using therapeutic EUS. LAMS, which included both AXIOS (Boston Scientific) and SPAXUS (Taewoong Medical) stents, were utilized. The AXIOS stents were available in sizes ranging from 6 × 8 mm to 20 × 10 mm, while the SPAXUS stents were available in sizes ranging from 8 × 20 mm to 16 × 20 mm. Endoscopists used either LAMS with or without a cautery tip based on their preferences or institutional availability. Placement of LAMS with a guidewire or using free-hand puncture technique was also at the discretion of the endoscopist.


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Results

A total of 270 patients were included, 125 of whom were male. The average age of the cohort was 61 ± 15 years ([Table 1]). Overall, use of LAMS in SAA was associated with a high technical success rate (98%) as well as a high clinical success rate (97%). The AE rate was 12% (n = 32/270). Twenty-one cases utilized non-cautery enhanced LAMS while 249 utilized cautery enhanced LAMS. In addition, 15 cases utilized SPAXUS stents where one AE was noted compared with the remaining 255 cases which utilized AXIOS stents with 31 associated AEs. To this end, there was no statistical differences in AEs between SPAXUS and AXIOS (P = 0.52). Cases using SPAXUS stents had 100% technical and 100% clinical success rates while AXIOS was associated with 98% technical success and 97% clinical success rates.

Table 1 Procedures and outcomes of lumen apposing metal stents in surgical anatomy.

Procedure and outcomes

Values

EUS, endoscopic ultrasound; ERCP, endoscopic retrograde cholangiopancreatography.

EUS-guided transgastric ERCP (EDGE) and EUS-directed transenteric ERCP (EDEE)

82

EUS-guided entero-enterostomy

81

EUS-guided biliary drainage

57

EUS-guided drainage of peri-pancreatic fluid collections

48

EUS-guided pancreatogastrostomy

2

AXIOS

255

SPAXUS

15

Technical Success

98%

Clinical Success

97%

Overall adverse events

12%

AGREE Classification

  • Grade II

5

  • Grade IIIa

21

  • Grade IIIb

6

Overall, AEs included early bleeding (2%), late bleeding (2%), perforation (2%), early migration (1%), late migration (1%), pulmonary embolism (< 1%), jaundice (< 1%), subhepatic fluid collection (< 1%), fever (< 1%), nausea & abdominal distention (< 1%), stent misdeployment (< 1%), and stent occlusion (< 1%). Two cases of late stent migration led to the formation of gastrocolonic fistulas.

EUS-directed transgastric ERCP and EUS-directed transenteric ERCP

Eighty-two patients with SAA underwent the EDGE procedure or EUS-directed transenteric ERCP (EDEE). Surgical anatomy included Roux-en-Y gastric bypass (80) and other (2). Indications included abdominal pain (4), abnormal computed tomography findings (1), afferent loop syndrome (1), bile leak (2), bleeding (1), common bile duct (CBD) stricture (3), cholangitis (21), choledocholithiasis (24), elevated liver enzymes (1), fine-need aspiration and radiofrequency ablation of an insulinoma at the head of the pancreas (1), unknown jaundice or obstruction (12), access pancreas (3), surgical stricture (1), unknown/other (6), and surgical exclusion (1). The stents used included 8 × 8 mm (HOT AXIOS; 1), 15 × 10 mm (Hot AXIOS; 9), and 20 × 10 mm (Hot AXIOS; 71). Overall, stent placement was associated with a high technical success rate and clinical success rate, as well as a low rate of AEs though two perforations were noted with one stent misdeployment ([Table 2]).

Table 2 Outcomes following EDGE and EDEE.

Procedure

n

Technical success

Clinical success

Adverse event

EDGE, endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography; EDEE, endoscopic ultrasound-directed transenteric endoscopic retrograde cholangiopancreatography.

EDGE

79

97.5%

97.5%

Early bleeding (1)

Early perforation (1)

Late perforation (1)

Abdominal distension/nausea (1)

EDEE

3

100%

100%

Stent misdeployment (1)


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EUS-guided entero-enterostomy

Eighty-one patients with SAA underwent creation of entero-enterostomy. Sixty-nine percent were indicated for malignancy whereas 31% were indicated for benign etiology. Surgical anatomy included proximal total gastrectomy (2), proximal subtotal gastrectomy (5), Billroth I (3), Billroth II (7), pylorus preserving Whipple (17), not pylorus preserving Whipple (18), Roux-en-Y gastric bypass (20), duodenal switch (1), distal gastrectomy (1), and others (7). Stents used for drainage included 16 × 20 mm (Cold SPAXUS; 2), 8 × 20 mm (Hot SPAXUS; 1), 10 × 20 mm (Hot SPAXUS; 1), 10 × 10 mm (Hot AXIOS; 1), 15 × 10 mm (Cold AXIOS; 28), 15 × 15 mm (Hot AXIOS; 3), and 20 × 10 mm (Hot AXIOS; 45). Overall, stent placement was associated with a high technical success rate and clinical success rate, as well as a low rate of AEs although two perforations were noted with one stent misdeployment ([Table 3]). Two cases (within the malignant subgroup) were not technically successful due to difficulty with distending the distal small bowel.

Table 3 EUS-guided placement of LAMS for biliary drainage.

Procedure

n

Technical success

Clinical success

Adverse event

EUS, endoscopic ultrasound; LAMS, lumen apposing stent.

EUS-cholecystogastrostomy

24

87.5%

79.2%

Early bleeding (2)

Early perforation (1)

EUS-choledochoduodenostomy

14

100%

93%

Impacted food (1)

EUS-colecystoduodenostomy

10

100%

100%

Stent occlusion from BD stone (1)

Jaundice 2/2 BD stricture (1)

Late bleeding (3)

Early bleeding (1)

EUS-cholecystojejunostomy

6

83.3%

83.3%

Stent misdeployment (1)

EUS-hepaticogastrostomy

2

100%

100%

Late migration (1)

Sub-hepatic collection (1)

EUS-choledochojejunostomy

1

100%

100%

None


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Biliary drainage

Fifty-seven patients with SAA underwent EUS-guided biliary drainage (BD) for malignant (n = 35) and non-malignant etiologies (n = 22). Surgical anatomy included Billroth II (14), Billroth I (12), pylorus preserving Whipple (8), not pylorus preserving Whipple (4), Roux-en-Y bypass (3), sleeve gastrectomy (3), total gastrectomy (2), proximal subtotal gastrectomy (2), partial gastrectomy with Roux-en-Y bypass (2), hepaticojejunostomy (2), bilio-digestive anastomosis (1), duodenojejunostomy (1), gastrojejunostomy (1), McKeon esophagectomy with Roux-en-Y bypass (1), and esophagectomy with hemigastrectomy and gastric pull-up (1).

For cases of malignant biliary obstruction, 34% of patients (n = 12/35) failed prior ERCP and stayed on average of 11 days in the hospital (total) and 9 days after their procedure. In patients who underwent CBD drainage, the average diameter was 18 ± 4 mm. Only AXIOS stents were used, which included 20 × 10 mm (8), 15 × 15 mm (5), 15 × 10 mm (8), 10 × 10 (4), 8 × 8 mm (4), and 6 × 8 mm (3), unknown (3). For non-malignant BD, cases were performed for indications of cholecystitis (15), biliary stones (3), biliary strictures (3), and cholangitis (1). LAMS used included 10 × 20 mm (1; SPAXUS), 10 × 10 mm (15), 15 × 10 mm (4), and 20 × 10 mm (2). Patients were discharged on average 6.5 days after their procedure. Overall, stent placement was associated with a very high technical success rate and clinical success rate, as well as a low rate of AEs ([Table 4]).

Table 4 Outcomes following EUS-guided creation of entero-enterostomy.

Procedure

n

Technical success

Clinical success

Adverse event

EUS-gastroenterostomy

64

97%

97%

Late bleeding (1)

Early stent migration (2)

Late stent migration (2)

Early perforation (1)

Pulmonary embolism (1)

EUS-jejunojejunostomy

13

100%

100%

Early migration (1)

EUS-gastroduodenostomy

1

100%

100%

None

ESU-duodenojejunostomy

3

100%

100%

Late bleeding (1)

Perigastric effusion (1)


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Drainage of peri-PFC

Forty-eight patients with SAA underwent drainage of peri-PFC. Surgical anatomy included proximal subtotal gastrectomy (1), Billroth I (4), Billroth II (2), sleeve gastrectomy (13), pylorus preserving Whipple (15), not pylorus preserving Whipple (8), Total pancreatectomy pylorus preserving (1), Roux-en-Y gastric bypass (2), and others (2). Patient symptoms included fever (16), nausea/vomiting (15), abdominal pain (13), fever + abdominal pain (2), asymptomatic (1), and poor oral intake with elevated CRP (1). The average fluid collection size was 82.5 ± 28.8 mm while the average fluid collection size at the time of stent removal was 19.2 ± 13.1 mm. Stents used for drainage included 10 × 20 mm (Cold SPAXUS; 5), 16 × 20 mm (Cold SPAXUS; 1), 16 × 20 mm (Hot SPAXUS; 4), 10 × 10 mm (Hot AXIOS; 14), 15 × 10 mm (Cold AXIOS; 9), 15 × 15 mm (Hot AXIOS; 10), and 20 × 10 mm (Hot AXIOS; 5). Overall, stent placement was associated with a high technical success rate and clinical success rate, as well as a low rate of AEs ([Table 5]). Furthermore, 20 cases utilized double pigtail stents whereas 28 cases did not use double pigtail stents, with no difference in outcomes noted.

Table 5 EUS-guided drainage of peri-pancreatic fluid collections.

Procedure

n

Technical success

Clinical success

Adverse event

EUS, endoscopic ultrasound.

EUS-cystgastrostomy without pigtail stents

25

100%

100%

Intraprocedural bleeding (1)

EUS-cystgastrostomy with pigtail stents

20

100%

100%

Delayed bleeding (1)

Fever (1)

EUS-cystjejunostomy without pigtail stents

1

100%

100%

None

Other

2

100%

100%

None


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Pancreaticogastrostomy

Two cases of pancreaticogastrostomy were reported in patients with non-pylorus preserving Whipple that utilized 6 × 8 mm hot AXIOS stents. Both procedures had 100% technical success and 100% clinical success with no AEs.


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Discussion

Our study represents the first extensive evaluation of LAMS placement in SAA. By conducting an international multicenter study involving 270 patients, we found that LAMS placement in SAA boasts impressive technical and clinical success rates. While AEs were notable, there were no endoscopy-related cases of mortality. Use of LAMS in SAA yielded a remarkable technical success rate of 98% and a clinical success rate of 97%. In total, 32 of 270 individuals experienced AEs, resulting in a 12% AE rate. These events encompassed early and late bleeding, perforation, migration, pulmonary embolism, jaundice, subhepatic fluid collection, fever, nausea and abdominal distention, stent misdeployment, and stent occlusion.

In our study, LAMS were used for biliary decompression in treatment of malignant biliary obstruction as well as treatment of non-malignant etiologies. To this end, EUS-BD is a viable alternative to ERCP, specifically by directly accessing the bile duct or the gallbladder [7]. A meta-analysis of 18 studies examining EUS-BD in SAA reported pooled technical success, clinical success, and AE rates of 97.8% (95% confidence interval [CI], 95.8–99.7%), 94.9% (95% CI, 91.8–98.1%), and 12.8% (95% CI, 7.4–18.1%), respectively [8]. Our results are in line with these outcomes. It is important to note that the European Society of Gastrointestinal Endoscopy recommends considering EUS-BD as a treatment option for malignant biliary obstruction after failed ERCP, provided local expertise is available [9].

Moreover, endoscopic gallbladder drainage is used in management of patients with cholecystitis who are deemed poor surgical candidates [10] [11]. Compared with the percutaneous approach, EUS-BD using LAMS has demonstrated similar technical and clinical success, but lower AE rates, shorter hospital stays, and reduced rates of unplanned readmissions and recurrent cholecystitis [12]. Despite limited data on LAMS placement for acute cholecystitis in SAA, our findings support the feasibility of this procedure in this specific patient population. Notably, our study showed 100% technical success and 100% clinical success, and minor AEs with no cases of perforation, misdeployment, or stent migration.

LAMS are used for managing symptomatic patients with peri-PFC. Our study reported outcomes of LAMS placement in SAA for the drainage of peri-PFC. To this end, we found that LAMS placement for this indication was associated with good technical and clinical success rates with minor AEs. No difference in outcomes was noted in cases utilizing double pigtail stents versus those not using double pigtail stents. A meta-analysis of eight studies (n = 460) showed that the clinical success rate (relative risk [RR] 1.00, 95% CI 0.87–1.14) and overall AE risk (RR 1.60, 95% CI 0.95–2.68) remained comparable between groups who used double pigtail stents versus those who did not use double pigtail stents [13].

In past decades, the EDGE or EDEE procedure has gained significant popularity, with Tyberg et al. suggesting 25 to 35 procedures were needed to become proficient [14] [15]. A retrospective multicenter study conducted by Runge et al. with 178 patients undergoing the EDGE procedure showed a technical success rate of 98% (175/178) with a mean procedure time of 92 minutes [16]. However, periprocedural AEs occurred in 15.7% of patients (mild 10.1%, moderate 3.4%, severe 2.2%), with laparoscopic management required for four severe cases [16]. A meta-analysis of 16 studies involving 470 patients showed a pooled technical success rate of 96% (95% CI 92% - 97.6%) where clinical success was achieved in 91% of cases (95% CI 85% - 95%) [17]. In addition, the study reported a 17% rate of AEs including failure of fistula closure (17%), stent migration (7%), bleeding (5%), post-EDGE weight gain (4%), perforation (4%), and post-ERCP pancreatitis (2%) [17]. Our study also found high technical and clinical success rates; however, two cases of perforation and one case of stent misdeployment were reported. Thus, this underscores a need for prudence and good endoscopic skills to minimize these risks.

This study also examined outcomes associated with creation of EUS-guided entero-enterostomies. Traditionally, this procedure was performed using a surgical approach. More recently, EUS-GE has been shown to be superior to enteral stenting in treating GOO. A recent randomized trial showed that EUS-guided gastroenterostomy led to reduced reintervention rates, better stent patency, and improved eating habits when compared with duodenal stenting [18]. Our study contributes to the growing body of literature showing that creation of entero-enterostomies is viable, even in patients with SAA [19] [20] [21]. Finally, two cases of pancreaticogastrostomy were reported with good outcomes. Although our study drew from a large international multicenter cohort, only two cases of LAMS placement for this indication were observed, thus illustrating that this procedure is rarely performed, even by expert endoscopists [22]. Larger studies evaluating endoscopic pancreaticogastrostomy are needed.

Our study has limitations. First, this was a retrospective study, which is subject to inherent bias, particularly selection bias. Second, we were unable to perform statistical comparisons due to the heterogeneity of the sample and the small sample sizes of specific procedures. Third, this study was underpowered to detect differences between stent types and should be interpreted with caution. Finally, long-term follow-up data are lacking. Despite these limitations, it remains the first and most extensive analysis of LAMS in patients with SAA across various indications. Moreover, our study draws on a vast sample size from multiple international centers. Given that prospective studies or randomized trials are not readily available specifically for patients with surgical anatomy, we are confident that our study offers valuable insights and guidance to endoscopists who frequently employ LAMS for these indications.


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Conclusions

In conclusion, interventional EUS has greatly broadened our therapeutic capabilities in creating novel gastrointestinal conduits. With the emergence of additional data, particularly in patients with SAA, it is anticipated that these endoscopic methods will become more common practice. Our study shows that LAMS placement in patients with SAA is effective and associated with good clinical outcomes. However, these procedures are associated with notable AEs.

Correction

Outcomes of lumen apposing metal stent placement in patients with surgically altered anatomy: Multicenter international experience
Benedetto Mangiavillano, Daryl Ramai, Michel Kahaleh et al.
Endoscopy International Open 2024; 12: E1143–E1149. DOI: 10.1055/a-2411-1814
In the above-mentioned article the name of the author Roberto Leone was corrected. This was corrected in the online version on 24.10.2024.


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Conflict of Interest

Benedetto Mangiavillano has no conflict of interest regarding this paper but is consultant for Taewoong medical.

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  • 3 Ichkhanian Y, Jovani M. Use of lumen apposing metal stents in patients with altered gastrointestinal anatomy. Curr Opin Gastroenterol 2023; 39: 348-355 DOI: 10.1097/MOG.0000000000000965. (PMID: 37530730)
  • 4 Chowdhury SD, Diez-Redondo P, Pérez-Miranda M. Approach to biliary access in patients with altered anatomy. Tech Gastrointest Endosc 2016; 18: 98-106
  • 5 Spadaccini M, Giacchetto CM, Fiacca M. et al. Endoscopic biliary drainage in surgically altered anatomy. Diagnostics 2023; 13: 3623 DOI: 10.3390/diagnostics13243623. (PMID: 38132207)
  • 6 Nass KJ, Zwager LW, van der Vlugt M. et al. Novel classification for adverse events in GI endoscopy: the AGREE classification. Gastrointest Endosc 2022; 95: 1078-1085 DOI: 10.1016/j.gie.2021.11.038. (PMID: 34890695)
  • 7 Sharaiha RZ, Khan MA, Kamal F. et al. Efficacy and safety of EUS-guided biliary drainage in comparison with percutaneous biliary drainage when ERCP fails: a systematic review and meta-analysis. Gastrointest Endosc 2017; 85: 904-914
  • 8 Tanisaka Y, Mizuide M, Fujita A. et al. Endoscopic ultrasound-guided biliary drainage in patients with surgically altered anatomy: A systematic review and Meta-analysis. Scand J Gastroenterol 2023; 58: 107-115
  • 9 van der Merwe SW, van Wanrooij RLJ, Bronswijk M. et al. Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2022; 54: 185-205 DOI: 10.1055/a-1717-1391. (PMID: 34937098)
  • 10 Koutlas NJ, Pawa S, Russell G. et al. Endoscopic ultrasound-guided gallbladder drainage: beyond cholecystitis. Diagnostics 2023; 13: 1933 DOI: 10.3390/diagnostics13111933. (PMID: 37296785)
  • 11 Crino SF, Rimbaș M, Gabbrielli A. et al. Endoscopic ultrasound guided gallbladder interventions: a review of the current literature. J Gastrointestin Liver Dis 2019; 28: 339-347 DOI: 10.15403/jgld-215. (PMID: 31517331)
  • 12 Teoh AYB, Kitano M, Itoi T. et al. Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: an international randomised multicentre controlled superiority trial (DRAC 1). Gut 2020; 69: 1085-1091
  • 13 Giri S, Harindranath S, Afzalpurkar S. et al. Does a coaxial double pigtail stent reduce adverse events after lumen apposing metal stent placement for pancreatic fluid collections? A systematic review and meta-analysis. Ther Advan Gastrointest Endosc 2023; 16 DOI: 10.5946/ce.2023.297.
  • 14 Kedia P, Sharaiha RZ, Kumta NA. et al. Internal EUS-directed transgastric ERCP (EDGE): game over. Gastroenterology 2014; 147: 566-568 DOI: 10.1053/j.gastro.2014.05.045. (PMID: 24975458)
  • 15 Tyberg A, Kedia P, Tawadros A. et al. EUS-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE): the first learning curve. J Clin Gastroenterol 2020; 54: 569-572 DOI: 10.1097/MCG.0000000000001326. (PMID: 32149820)
  • 16 Runge TM, Chiang AL, Kowalski TE. et al. Endoscopic ultrasound-directed transgastric ERCP (EDGE): a retrospective multicenter study. Endoscopy 2021; 53: 611-618 DOI: 10.1055/a-1254-3942. (PMID: 32882722)
  • 17 Deliwala SS, Mohan BP, Yarra P. et al. Efficacy & safety of EUS-directed transgastric endoscopic retrograde cholangiopacreatography (EDGE) in Roux-en-Y gastric bypass anatomy: a systematic review & meta-analysis. Surg Endosc 2023; 37: 4144-4158
  • 18 Teoh AY, Lakhtakia S, Tarantino I. et al. Endoscopic ultrasonography-guided gastroenterostomy versus uncovered duodenal metal stenting for unresectable malignant gastric outlet obstruction (DRA-GOO): A multicentre randomised controlled trial. Lancet Gastroenterol Hepatol 2024; 9: 124-132 DOI: 10.1016/S2468-1253(23)00242-X. (PMID: 38061378)
  • 19 Amato A, Tarantino I, Facciorusso A. et al. Real-life multicentre study of lumen-apposing metal stent for EUS-guided drainage of pancreatic fluid collections. Gut 2022; 71: 1050-1052 DOI: 10.1136/gutjnl-2022-326880. (PMID: 35193984)
  • 20 Mangiavillano B, Moon JH, Crinò SF. et al. Safety and efficacy of a novel electrocautery-enhanced lumen-apposing metal stent in interventional EUS procedures (with video). Gastrointest Endosc 2022; 95: 115-122
  • 21 Facciorusso A, Amato A, Crinò SF. et al. Definition of a hospital volume threshold to optimize outcomes after drainage of pancreatic fluid collections with lumen-apposing metal stents: a nationwide cohort study. Gastrointest Endosc 2022; 95: 1158-1172
  • 22 Hayat U, Freeman ML, Trikudanathan G. et al. Endoscopic ultrasound-guided pancreatic duct intervention and pancreaticogastrostomy using a novel cross-platform technique with small-caliber devices. Endosc Int Open 2020; 8: E196-E202

Correspondence

Dr. Benedetto Mangiavillano
Gastrointestinal Endoscopy, Istituto Clinico Mater Domini Casa di Cura Privata SpA
Via Gerenzano 2
21053 Castellanza
Italy   

Publication History

Received: 26 June 2024

Accepted after revision: 06 September 2024

Accepted Manuscript online:
09 September 2024

Article published online:
10 October 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

  • References

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  • 2 Bhenswala P, Lakhana M, Gress FG. et al. Novel uses of lumen-apposing metal stents: a review of the literature. J Clin Gastroenterol 2021; 55: 641-651 DOI: 10.1097/MCG.0000000000001566. (PMID: 34049379)
  • 3 Ichkhanian Y, Jovani M. Use of lumen apposing metal stents in patients with altered gastrointestinal anatomy. Curr Opin Gastroenterol 2023; 39: 348-355 DOI: 10.1097/MOG.0000000000000965. (PMID: 37530730)
  • 4 Chowdhury SD, Diez-Redondo P, Pérez-Miranda M. Approach to biliary access in patients with altered anatomy. Tech Gastrointest Endosc 2016; 18: 98-106
  • 5 Spadaccini M, Giacchetto CM, Fiacca M. et al. Endoscopic biliary drainage in surgically altered anatomy. Diagnostics 2023; 13: 3623 DOI: 10.3390/diagnostics13243623. (PMID: 38132207)
  • 6 Nass KJ, Zwager LW, van der Vlugt M. et al. Novel classification for adverse events in GI endoscopy: the AGREE classification. Gastrointest Endosc 2022; 95: 1078-1085 DOI: 10.1016/j.gie.2021.11.038. (PMID: 34890695)
  • 7 Sharaiha RZ, Khan MA, Kamal F. et al. Efficacy and safety of EUS-guided biliary drainage in comparison with percutaneous biliary drainage when ERCP fails: a systematic review and meta-analysis. Gastrointest Endosc 2017; 85: 904-914
  • 8 Tanisaka Y, Mizuide M, Fujita A. et al. Endoscopic ultrasound-guided biliary drainage in patients with surgically altered anatomy: A systematic review and Meta-analysis. Scand J Gastroenterol 2023; 58: 107-115
  • 9 van der Merwe SW, van Wanrooij RLJ, Bronswijk M. et al. Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2022; 54: 185-205 DOI: 10.1055/a-1717-1391. (PMID: 34937098)
  • 10 Koutlas NJ, Pawa S, Russell G. et al. Endoscopic ultrasound-guided gallbladder drainage: beyond cholecystitis. Diagnostics 2023; 13: 1933 DOI: 10.3390/diagnostics13111933. (PMID: 37296785)
  • 11 Crino SF, Rimbaș M, Gabbrielli A. et al. Endoscopic ultrasound guided gallbladder interventions: a review of the current literature. J Gastrointestin Liver Dis 2019; 28: 339-347 DOI: 10.15403/jgld-215. (PMID: 31517331)
  • 12 Teoh AYB, Kitano M, Itoi T. et al. Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: an international randomised multicentre controlled superiority trial (DRAC 1). Gut 2020; 69: 1085-1091
  • 13 Giri S, Harindranath S, Afzalpurkar S. et al. Does a coaxial double pigtail stent reduce adverse events after lumen apposing metal stent placement for pancreatic fluid collections? A systematic review and meta-analysis. Ther Advan Gastrointest Endosc 2023; 16 DOI: 10.5946/ce.2023.297.
  • 14 Kedia P, Sharaiha RZ, Kumta NA. et al. Internal EUS-directed transgastric ERCP (EDGE): game over. Gastroenterology 2014; 147: 566-568 DOI: 10.1053/j.gastro.2014.05.045. (PMID: 24975458)
  • 15 Tyberg A, Kedia P, Tawadros A. et al. EUS-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE): the first learning curve. J Clin Gastroenterol 2020; 54: 569-572 DOI: 10.1097/MCG.0000000000001326. (PMID: 32149820)
  • 16 Runge TM, Chiang AL, Kowalski TE. et al. Endoscopic ultrasound-directed transgastric ERCP (EDGE): a retrospective multicenter study. Endoscopy 2021; 53: 611-618 DOI: 10.1055/a-1254-3942. (PMID: 32882722)
  • 17 Deliwala SS, Mohan BP, Yarra P. et al. Efficacy & safety of EUS-directed transgastric endoscopic retrograde cholangiopacreatography (EDGE) in Roux-en-Y gastric bypass anatomy: a systematic review & meta-analysis. Surg Endosc 2023; 37: 4144-4158
  • 18 Teoh AY, Lakhtakia S, Tarantino I. et al. Endoscopic ultrasonography-guided gastroenterostomy versus uncovered duodenal metal stenting for unresectable malignant gastric outlet obstruction (DRA-GOO): A multicentre randomised controlled trial. Lancet Gastroenterol Hepatol 2024; 9: 124-132 DOI: 10.1016/S2468-1253(23)00242-X. (PMID: 38061378)
  • 19 Amato A, Tarantino I, Facciorusso A. et al. Real-life multicentre study of lumen-apposing metal stent for EUS-guided drainage of pancreatic fluid collections. Gut 2022; 71: 1050-1052 DOI: 10.1136/gutjnl-2022-326880. (PMID: 35193984)
  • 20 Mangiavillano B, Moon JH, Crinò SF. et al. Safety and efficacy of a novel electrocautery-enhanced lumen-apposing metal stent in interventional EUS procedures (with video). Gastrointest Endosc 2022; 95: 115-122
  • 21 Facciorusso A, Amato A, Crinò SF. et al. Definition of a hospital volume threshold to optimize outcomes after drainage of pancreatic fluid collections with lumen-apposing metal stents: a nationwide cohort study. Gastrointest Endosc 2022; 95: 1158-1172
  • 22 Hayat U, Freeman ML, Trikudanathan G. et al. Endoscopic ultrasound-guided pancreatic duct intervention and pancreaticogastrostomy using a novel cross-platform technique with small-caliber devices. Endosc Int Open 2020; 8: E196-E202