Introduction
In 1979, percutaneous endoscopic gastrostomy (PEG) was described by Gauderer et al
as a new technique for performing gastrostomy without laparotomy [1 ]. The authors introduced the pull-through technique for PEG. Here, a thread is placed
percutaneously into the stomach and the feeding tube is pulled by this thread through
the patient´s mouth into the stomach and through the abdominal wall. The pull-through
technique has become the standard procedure for PEG over the years. The complication
rate for this technique varies between 4.9 % and 23.8 % in interventions documented
in the literature [2 ]
[3 ]
[4 ].
Besides pull-through, the direct puncture technique was reported about in 2007 by
Toyama et al. [5 ], and has been applied in recent years. This technique uses a specially designed
sewing needle to fix stomach and abdominal wall. After implementation of the percutaneous
gastropexy, a trocar with an overlying peel-away sheath is introduced percutaneously
under endoscopic control into the stomach, and after removing the trocar, the feeding
tube is placed through the sheath. This technique has become the standard method in
cases in which anatomical barriers related to malignant diseases such as head and
neck cancer hinder the placement of a feeding tube through the esophagus.
Five trials (three prospective and two retrospective) demonstrated fewer complications
with application of the direct puncture technique, especially with respect to a lower
rate of local infections compared to application of the pull-through technique in
408 patients [6 ]
[7 ]
[8 ]
[9 ]
[10 ]. In 2011, different results were reported by van Dyck et al [11 ], who published a retrospective analysis of 57 patients, identifying the direct puncture
technique to be associated with a significantly higher complication rate (11/24, 48 %)
when compared to the pull-through technique (4/33,12 %, P < 0.05). Teich et al. confirmed these data in a prospective randomized trial with
120 patients (per protocol treatment) with an early complication rate of 33 serious
adverse events in 58 patients in the direct puncture technique group versus 14 of
62 patients in the pull-through technique group (P = 0.001) [4 ]. This thorough compilation of the complication rates with the pull-through and direct
puncture techniques returned contradictory results.
Despite these contradictory results with low-quality evidence, the European Society
of Gastrointestinal Endoscopy (ESGE) recommends the pull-through technique as the
standard method for PEG placement, and the direct puncture technique only in cases
in which pull-through is contraindicated [12 ].
To increase the evidence of superiority for one of these procedures, we retrospectively
analyzed risk of complications for the pull-through and direct puncture techniques
in our cohort of 1201 patients. The aim of this study was to estimate and compare
interventional risk for both techniques, independent of possible confounders such
as age, underlying disease, and indication for PEG.
Patients and methods
Study design and data collection
Clinical data from patients who had undergone a PEG procedure in four-high volume
centers for endoscopy were collected retrospectively between January 2016 and December
2018.
Data including gender, age, body mass index, underlying disease, leading indication,
PEG technique, complications, and follow-up information for 60 days were retrieved
from the patient management software of each center. The Institutional Ethics Review
Board of the Charité – Universitätsmedizin Berlin, Germany (EA4/036/18) approved this
study.
PEG procedure
PEG procedures were based on the recommendations of the ESGE Guidelines [12 ].
Written informed consent for the PEG procedure was obtained from all patients at least
24 hours prior to the intervention. Only patients without clinical and serological
signs of an acute infection (no leukocytosis and no C-reactive protein level more
than 10 times above the norm) were eligible for PEG intervention. Patients fasted
overnight. Periinterventional antibiotic prophylaxis was administered 30 minutes prior
to the intervention. Patients were placed supine and were sedated with propofol and
midazolam. Oxygen was applied with a nasal cannula or, if applicable, with a tracheostomy
tube. During the entire procedure, heart rate, blood pressure, and oxygenation monitoring
was performed following the standard sedation guidelines [13 ].
An esophagogastroduodenoscopy was performed to exclude any contraindications for PEG.
Subsequently the stomach was insufflated with CO2 for maximal stomach wall extension and, after disinfection of the abdominal wall,
the site for PEG placement was chosen by gastroscopic transillumination. This area
was infiltrated with lidocaine as a local anesthetic and a needle (20G) was introduced
percutaneously into the stomach.
Pull-through technique
For the pull-through technique, a thread was placed into the stomach via the percutaneous
needle. The thread was grabbed with endoscopic forceps and pulled out of the patient´s
mouth. The thread was fixed to the PEG device and the PEG tube was introduced through
the mouth into the stomach by pulling the thread. The final position of the tube was
reached when the internal retention disk of the tube touched the stomach wall. The
internal retention disk and external fixation plate were tightened firmly for 24 hours.
This process causes the stomach and abdominal wall to adhere ([Fig. 1a ]) [13 ].
Fig. 1 Schema for a classical pull-through technique and b direct puncture technique.
Direct puncture technique
For the direct puncture technique, the stomach and abdominal wall were fixed with
the aid of a gastropexy device (Gastropexie Device II, Fresenius-Kabi Deutschland
GmbH, Bad Homburg, Germany). The sutures were placed in three to four locations with
a distance of approximately 2 cm around the identified PEG insertion site ([Fig. 1b ]). After skin incision, the trocar with an overlying peel-away sheath was inserted
through the skin incision into the stomach under direct endoscopic visualization.
In the next step, the metal trocar was removed, and the feeding tube was inserted
through the leaving peel-away sheath in situ. After the intragastric fixation balloon
was filled with water, the sheath was removed ([Fig. 1b ]). Gastropexy sutures were removed 2 to 3 weeks after intervention [5 ].
Monitoring of complications and mortality
All patients who received a PEG were followed up by a specialized nursing team and
corresponding complications were documented in the patient management software. Postinterventional
complication and mortality rates were monitored for a minimum period of 60 days after
intervention. Major complications were considered when potentially life-threatening
events occurred whereas minor complications were all other unwanted postinterventional
events. Intervention-related mortality was defined as death caused by the PEG intervention
(all cases were caused by peritonitis after PEG intervention).
Statistical analysis
Quantitative values are expressed as mean and range, and categorical values with absolute
and relative frequencies (count of events and percent). The 60-day complication probability
was evaluated in the first 60 days after the intervention using Kaplan-Meier plots.
The X2 -test was used for comparison of frequencies. Multivariate comparison of frequencies
was analyzed by binary logistic regression analysis. P < 0.05 was considered as statistically significant. IBM SPSS Version 21 (Ehningen,
Germany) was used for statistical analysis.
Results
Patients
Data from 1201 patients were retrieved for this study ([Table 1 ]). The median age was 65.6 years with a range of 18 to 103 years. Of the patients,
36.6 % (n = 439) were women. Six-hundred-forty patients (53.3 %) suffered from a malignant
disease, 497 (41.4 %) from a neurologic disorder, and 64 patients from other disorders
including disability after resuscitation, long-term ventilation or polytrauma.
Table 1
Patient characteristics and subgroup analysis of pull-through technique and the direct
puncture technique.
All
PEG technique
Total
Pull-through
Direct puncture
P
n
(%)
n
(%)
n
(%)
Gender
0.236
439
(36.6)
365
(35.9)
74
(40.4)
762
(63.4)
653
(64.1)
109
(59.6)
Age group
0.725
513
(42.7)
437
(42.9)
76
(41.5)
688
(57.3)
581
(57.1)
107
(58.5)
Body mass index (kg/m2 )
0.001
117
(9.7)
90
(8.8)
27
(14.8)
411
(34.2)
334
(32.8)
77
(42.1)
420
(35.0)
367
(36.1)
53
(29.0)
253
(21.1)
227
(22.3)
26
(14.2)
Underlying disease
< 0.001
640
(53.3)
518
(50.9)
112
(64.7)
497
(41.4)
445
(43.7)
52
(30.1)
64
(5.3)
55
(5.4)
9
(5.2)
Leading indication
< 0.001
570
(47.5)
510
(50.1)
60
(32.8)
187
(15.6)
141
(13.9)
46
(25.1)
427
(35.6)
364
(35.8)
63
(34.4)
17
(1.4)
3
(0.3)
14
(7.7)
PEG reinsertion
< 0.001
1065
(88.7)
948
(93.1)
117
(63.9)
136
(11.3)
70
(6.9)
66
(36.1)
PEG, percutaneous endoscopic gastrostomy.
In 570 cases (47.5 %), the indication for a PEG procedure was neuromotor dysfunction
such as recurrent aspiration, dysphagia, or reduced consciousness. In 187 cases (15.6 %),
it was for palliation (gastric outlet obstruction, cachexia), and in 427 cases (35.6 %),
it was part of prophylactic maintenance of enteral nutrition in patients with head
and neck tumors during radiation therapy. Seventeen patients (1.4 %) received a PEG
as part of Duodopa therapy for their Parkinson’s disease with enteral application
of levodopa/carbidopa gel.
In 136 cases (11.3 %), patients had a PEG previously and PEG reinsertion was necessary.
The main reason for that was recurrence of a head and neck cancer.
Direct puncture was performed in 183 cases (15.3 %) of the interventions and was significantly
more common in underweight and normal weight patients (P = 0.001), in patients with malignant diseases (P < 0.001), individuals with an indication for palliation or Duodopa therapy (P < 0.001), and in cases in which a PEG reinsertion was necessary ([Table 1 ]).
Complications
Major complications occurred in 117 of 1201 cases (9.8 %). The leading causes were
severe wound infection (5.1 %), peritonitis (5.6 %), and PEG dislocation (6.2 %) ([Table 2 ]). Minor complications occurred in 279 of 1201 cases (23.3 %) and required an additional
diagnostic procedure in 250 cases (20.9 %). Minor complications were, in detail: increased
inflammation parameter (14.5 %), local wound infections (12.3 %), requirement for
antibiotics (12.4 %), and pain (16.2 %) ([Table 2 ]). Comparisons of the two techniques revealed a significant reduction in the major
complication rate by 85.7 % in the direct puncture group (direct puncture 1.6 %, pull-through
11.2 %; P < 0.001). The minor complication rate also was reduced by 50 % in the direct puncture
group when compared to the pull-through group (direct puncture technique 12.6 %, pull-through
technique 25.2 %; P < 0.001) ([Table 2 ]). In particular, the rate of infection-related complications, acute abdomen, peritonitis,
pneumoperitoneum, pain, and PEG leakage were significantly reduced by using the direct
puncture technique.
Table 2
Major and minor complications in the analyzed patient cohort and correlation with
the employed PEG techniques.
All
PEG technique
Total
Pull-through
Direct punction
P
n
(%)
n
(%)
n
(%)
Major complication
117
(9.8)
114
(11.2)
3
(1.6)
< 0.001
61
(5.1)
61
(6.0)
0
(0.0)
< 0.001
49
(4.1)
47
(4.6)
2
(1.1)
0.026
67
(5.6)
65
(6.4)
2
(1.1)
0.004
28
(2.3)
28
(2.8)
0
(0.0)
0.023
43
(3.6)
43
(4.2)
0
(0.0)
0.005
9
(0.8)
8
(0.8)
1
(0.5)
0.727
27
(2.3)
26
(2.6)
1
(0.5)
0.091
7
(0.6)
7
(0.7)
0
(0.0)
0.260
74
(6.2)
74
(7.3)
3
(1.6)
0.006
20
(1.7)
20
(2.0)
0
(0.0)
0.055
Minor complication
279
(23.3)
256
(25.2)
23
(12.6)
< 0.001
174
(14.5)
158
(15.6)
16
(8.7)
0.016
250
(20.9)
228
(22.5)
22
(12.0)
0.001
95
(7.9)
84
(8.3)
11
(6.0)
0.295
194
(16.2)
178
(17.6)
16
(8.7)
0.003
34
(2.8)
31
(3.1)
3
(1.6)
0.288
147
(12.3)
132
(13.0)
14
(7.7)
0.067
100
(8.4)
95
(9.4)
5
(2.7)
0.003
113
(9.4)
102
(10.1)
11
(6.0)
0.085
59
(4.9)
53
(5.2)
6
(3.3)
0.262
148
(12.4)
133
(13.1)
15
(8.2)
0.063
50
(4.2)
49
(4.8)
1
(0.5)
0.008
Death within 60 days after intervention
122
(10.9)
91
(8.9)
31
(16.9)
0.001
8
(0.7)
7
(0.7)
1
(0.5)
0.829
PEG, percutaneous endoscopic gastrostomy.
Overall 60-day mortality was significantly higher in the direct puncture group (16.9 %)
than in the pull-through group (8.9 %); P < 0.001). Detailed examination of 60-day mortality showed a significantly higher
number of cases with malignant diseases and palliative PEG indications in the direct
puncture group ([Table 3 ]). Therefore, analysis of the intervention-specific mortality could not confirm this
difference (pull-through technique 0.7 % [n = 7] vs. direct puncture technique 0.5 %
[n = 1]; P = 0.829, [Table 2 ]). A subgroup analysis of intervention-related 60-day mortality revealed significantly
higher mortality in women, normal weight patients, and patients with malignant disease
in the pull-through technique group, whereas the direct puncture technique group showed
no significant differences in the subgroup analysis ([Table 3 ]). Despite their statistical significance, the subgroup effects have no practical
relevance due to the low number of intervention-related deaths (pull-through technique
n = 7, direct puncture technique n = 1).
Table 3
Subgroup analysis of pull-through and direct puncture technique-related mortality
within 60 days after intervention in respect to patient characteristics.
Intervention-related 60-day mortality
All
Pull-through
Direct puncture
n
(%)
P
n
(%)
P
n
(%)
P
Gender
0.126
0.049
0.409
5
(1.1)
5
(1.4)
0
(0.0)
3
(0.4)
2
(0.3)
1
(0.9)
Age group
0.246
0.446
0.234
5
(1.0)
4
(0.9)
1
(1.3)
3
(0.4)
3
(0.5)
0
(0.0)
Body mass index (kg/m2 )
0.085
0.028
0.481
0
(0.0)
0
(0.0)
0
(0.0)
6
(1.5)
6
(1.8)
0
(0.0)
2
(0.5)
1
(0.3)
1
(1.9)
0
(0.0)
0
(0.0)
0
(0.0)
Underlying disease
0.41
0.024
0.778
4
(0.6)
3
(0.6)
1
(0.8)
2
(0.4)
2
(0.4)
0
(0.0)
2
(3.1)
2
(3.6)
0
(0.0)
Leading indication
0.841
0.979
0.392
4
(0.7)
4
(0.8)
0
(0.0)
2
(1.1)
1
(0.7)
1
(2.2)
2
(0.5)
2
(0.5)
0
(0.0)
0
(0.0)
0
(0.0)
0
(0.0)
PEG reinsertion
0.916
0.437
0.451
7
(0.7)
6
(0.6)
1
(0.9)
1
(0.7)
1
(1.4)
0
(0.0)
All
8
(0.7)
7
(0.7)
1
(0.5)
PEG, percutaneous endoscopic gastrostomy.
Most complications occurred in the first 24 hours after the intervention. In this
time window, the complication rate was significantly increased in the pull-through
technique group. After 24 hours, the complication rate was comparable for the two
techniques ([Fig. 2 ]).
Fig. 2 Cumulative probability for complications in the first 60 days after intervention
depending on pull-through technique (n = 1018) and direct puncture technique (n = 183).
Significance calculated by log-rank test.
To identify independent risk factors for major complications, a multivariate binary
logistic regression analysis was performed. The analysis identified the direct puncture
technique as the strongest protective factor (odds ratio [OR] 0.067; 95 %CI 0.02–0.226;
P < 0.001). PEG reinsertion procedure was identified as the highest risk for complication
(OR 4.018 [95 % CI: 2.24–7.20] P < 0.001). A lower risk for complications was seen in women (OR 0.597 [95 % CI: 0.40–90]
P = 0.013) and patients with neurological disease (OR 0.519 [95 % CI: 0.28–0.97] P = 0.040) ([Fig. 3 ]).
Fig. 3 Multivariate binary logistic regression analysis for major complication risk in PEG
procedures. Significance calculated by log-rank test (*level of significance reached).
Discussion
This retrospective multicenter analysis aimed to compare the complication rates of
PEG procedures by comparing two techniques: classical pull-through and direct puncture.
Our data provide evidence indicating a clear advantage of the direct puncture technique
with a complication rate of 1.6 % compared to the pull-through technique with 11.2 %
(P < 0.001) within the first 60 days after intervention. Multivariate analysis revealed
an OR of 0.067 for direct puncture, resulting in a 14.9-fold increase in major complications
by using the pull-through technique.
Subgroup analysis indicated that for the direct puncture technique, the decrease in
complications was driven by a reduction in infections (severe wound infection, peritonitis,
and subcutaneous abscess) as well as complications related to insufficient adherence
of stomach and abdominal wall (peritonitis, acute abdomen, pneumoperitoneum, and dislocation
requiring surgery). The reduction in infectious complications documented here for
use of the direct puncture technique was previously reported in five of seven studies
comparing the two techniques [4 ]
[5 ]
[6 ]
[7 ]
[8 ]
[9 ]
[11 ]. Most authors suggested that the increased infection rate in the pull-through technique
group was mediated by the spread of bacteria from the oropharyngeal area [6 ]
[7 ]
[8 ]
[9 ]
[10 ]. This occurs during the pull-through of the PEG tube through the mouth and esophagus,
which is not required with the direct puncture technique.
To our knowledge, this is the first time that a significant reduction in acute abdomen
by using direct puncture has been described. This may be due to the low incidence
of these events (4.1 %), which requires a larger study population. Most of the complications
associated with both techniques occurred within the first 24 hours following the intervention.
The main advantage of direct puncture was the reduction in these early complications.
When evaluating these data, it must be considered that the major complication rate
in the group that underwent direct puncture was so low that a subgroup analysis could
only be evaluated for the pull-through technique group ([Table 3 ]).
Two previous publications identified an increased rate of tube dislocation when using
direct puncture technique as a potential disadvantage [4 ]
[11 ]. This may be due to the balloon technique. Remarkably, this was not detected within
the 60-day observation period in our study.
Inherent in retrospective studies, patient stratification was not possible. The gastrostomy
technique was selected by the individual physician and was dependent on the respective
indication of the underlying disease. Patient characteristics were not for BMI, leading
indications, underlying diseases, and rate of PEG reinsertion. The direct puncture
group included more patients receiving palliation, who had an almost doubled 60-day
overall mortality rate. This higher mortality and morbidity in the direct puncture
group was also observed in two other retrospective analyses: A higher overall mortality
rate (direct puncture technique 8 %, pull-through technique 0 %) was found in a study
population not balanced for World Health Organization performance status (direct puncture
technique = 2, pull-through technique = 1) [11 ], and Tucker et al. reported a higher percentage of patients receiving palliation
in the direct puncture technique group (direct puncture technique 82.7 %, pull-through
technique 12.0 %). Mortality was not analyzed in this study [8 ]. Heterogeneity of patients in our cohort was unfavorable for the outcome of the
direct puncture technique, but despite this imbalance, the minor and major complication
rates were significantly reduced in patients with poor prognosis who underwent direct
puncture.
Because of the retrospective design of this study, it must be considered that it is
possible that not all post-intervention complications could be monitored after the
patients were discharged from the hospital. Given the close follow-up care of our
specialized care teams, there will only be a few cases here. This confounder will
also affect both groups equally.
Conclusions
PEG is one of the interventions with the highest complication rates in interventional
endoscopy, but it is still considered a safe procedure. This analysis of our large
patient population identified a 90 % reduction in major complication rate associated
with use of the direct puncture technique. Despite the retrospective design of this
study, the data suggest the superiority of direct puncture and provide justification
for the initiation of larger, prospective randomized multicenter trials. Based on
the results we have presented, current practice of PEG should be carefully reconsidered,
pending the availability of results from controlled studies.
Complication rates of direct puncture and pull-through techniques for percutaneous
endoscopic gastrostomy: Results from a large multicenter cohort Leonie Schuhmacher, Christian Bojarski, Victoria Reich et al. Endoscopy International
Open 2022; 10: E1454–E1461. DOI: 10.1055/a-1924-3525
