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Endoscopic Treatment of Staple-Line Leaks After Sleeve Gastrectomy in Patients with Obesity: Which One is the Best Option, if Any? A Systematic Review with Meta-Analysis and Meta-regression

  • Open Access
  • 20.10.2025
  • Review
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Abstract

Laparoscopic sleeve gastrectomy (LSG) is the most common bariatric surgery, with staple-line leak (SLL) as its most severe complication. Various endoscopic treatments exist, but no universal algorithm is established. The aim of this paper is to estimate the success rates of different endoscopic techniques for SLL management. A search of Medline, Embase, and SCOPUS identified studies on endoscopic treatments. Pooled success rates were calculated using random-effects modeling. Seventy-nine studies (2205 patients) showed an overall success rate of 84.1%. Double-pigtail drainage (90.07%), endoscopic vacuum therapy (90.2%), and septotomy (88.25%) were most effective. Meta-regression indicated significantly higher success with double-pigtail drainage (p = 0.035). Endoscopic treatments, especially double-pigtail drainage and vacuum therapy, are highly effective for SLL. Further research is needed to compare techniques and evaluate additional clinical factors. 

Supplementary Information

The online version contains supplementary material available at https://doi.org/10.1007/s11695-025-08294-6.

Key points

  • Laparoscopic sleeve gastrectomy (LSG) is the most performed primary bariatric intervention.
  • The most life-threatening complication of LSG is the staple-line leak (SLL).
  • Among the proposed options to treat SLL, the endoscopic approaches are a very useful option.
  • Our study shows the efficacy of double-pigtail and endo-vacuum treatments in managing SLL after LSG.

Publisher'S Note

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Introduction

Laparoscopic sleeve gastrectomy (LSG) is currently the most common bariatric procedure worldwide, accounting for 45–75% of primary interventions in the USA, with favorable outcomes in terms of weight loss [1, 2]. The most serious complication of LSG is a staple-line leak (SLL), with an average reported incidence ranging from 0 to 7% [3], although the trend is decreasing [4]. Despite this, the life-threatening nature of this complication demands careful consideration [5, 6].
Several surgical and non-surgical strategies have been proposed for managing SLL after LSG. The American Society for Metabolic and Bariatric and Surgery (ASMBS) recommends conservative, non-surgical treatment as the first-line approach, with endoscopic procedures—including stenting, pigtail drainage, over-the-scope clips (OTSC) or through-the-scope clips (TTSC), vacuum therapy, septotomy, and tissue sealants representing valuable options [4].
Unfortunately, the available evidence remains inconclusive due to the numerical inconsistency (case reports or short case series) and the high heterogeneity of the most published literature data (very often based on retrospective observational studies). As a result, no universally accepted management algorithm has yet been established [7]. The best evidence could be provided by prospective randomized clinical trials, but these are difficult to perform for practical and ethical reasons.
Therefore, we performed a systematic review with meta-analysis of the most recent literature on the endoscopic treatments for SLL after LSG, including tissue sealants, internal drainage, stenting, clipping, vacuum therapy, septotomy, endoscopic suturing, and occluders.
This paper aims to analyze, on the grounds of the literature-based findings, the different techniques of endoscopic management of staple-line leaks after LSG, assessing and comparing their technical characteristics, successful closure rate, and technical and clinical outcomes.

Material and Methods

The systematic review and the meta-analysis were performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines [8].

Search Strategy

A systematic search of the Medline, Embase, and SCOPUS databases from inception to January 11, 2024, was conducted using the terms “sleeve,” “gastrectomy,” “complication,” “leak,” “dehiscence,” “fistula,” “endoscopic,” “management,” and “treatment”; related words; and Medical Headings (Supplementary File 1, Search strategy for Medline). The search was limited to articles published in English, and there was no restriction according to the publication status. The reference list of selected studies was screened to identify additional potentially relevant studies.

Study Selection

To be selected for the meta-analysis, the studies had to meet the following criteria: (1) to include patients who underwent sleeve gastrectomy and subsequently developed a leak from the staple-line; (2) these patients had to undergo an endoscopic treatment of the leak as first- or second-line treatment; (3) to report outcomes of the endoscopic treatment; (4) to include at least five patients, to prevent instability and imprecision in the meta-analytic model. Conference abstracts and non-human studies were excluded.

Data Extraction and Quality Assessment

Four reviewers (P.M., C.A., M.R., V.R.) extracted data from each selected study regarding the first author, publication year, country of origin, design, number of included patients with a diagnosis of SLL, SLL classification according to the timing of occurrence (acute, early, and chronic), location (esophagogastric junction), type and characteristics of the endoscopic treatment, if the endoscopic treatment was performed as first- or second-line treatment, if the endoscopic treatment was combined or not with additional treatments, and number of successful cases. If the study reported the success rate of different endoscopic approaches, these data were analyzed separately to estimate the efficacy of different interventions. Similarly, whenever possible, the efficacy of the endoscopic treatments was analyzed according to the location and timing of the occurrence of SLL. The quality of each study was evaluated by a modified version of the Newcastle–Ottawa scale for the assessment of the quality of non-randomized studies [9]. By this tool, each study quality was appraised by exploring four domains related to patient selection, outcome measurement tools, outcome assessment, and adjustment for confounders.

Statistical Analysis

The primary outcome was the overall success rate of the endoscopic treatments. Secondary outcomes were the success rate of each type of endoscopic treatment, and according to leak location, timing of occurrence, and line of treatment, the complication rate of the endoscopic treatment.
The success rate was calculated by dividing the number of patients achieving success with the endoscopic treatment by the total number of patients undergoing the endoscopic treatment. Pooled rates, expressed as a percentage, rounded to one decimal place, with 95% confidence intervals, were computed using a random-effect model according to the DerSimonian and Laird method [10]. The Freeman-Tukey double arcsine transformation of the prevalence was used to incorporate in the pooled analysis also studies with rates equal to 0% [11]. The presence of heterogeneity among the studies was assessed by the Cochrane Q test and quantified with the inconsistency index (I2), with I2 values of 25, 50, and 75% considered indicative of low, moderate, and high statistical heterogeneity [12]. To further explore and address heterogeneity, subgroup analyses and random-effects meta-regression (restricted maximum likelihood method) were performed to evaluate the impact of treatment type, leak location, timing of occurrence, and line of treatment on treatment success [13]. Influence analysis was performed by leaving each study out in turn and re-computing the summary effect to assess the impact of each study on the overall estimate and heterogeneity. Publication bias was assessed by using Egger’s linear regression method [14]. A p-value < 0.05 was considered statistically significant. R version 3.6.1 (2019, The R Foundation for Statistical Computing) was used for statistical analyses.

Results

Study Selection and Characteristics

A total of 79 studies met the inclusion criteria and were selected for this meta-analysis according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) (Fig. 1). The characteristics of the included studies are reported in Table 1. A total of 2205 patients undergoing endoscopic treatment for a staple-line leak following sleeve gastrectomy were included in this meta-analysis. Forty-seven studies reported information regarding the timing of staple-line leak occurrence [2, 7, 1559], while 48 studies reported information regarding leak location [2, 7, 1517, 19, 2131, 3437, 39, 40, 4345, 4752, 54, 55, 57, 58, 6071].
Fig. 1
Articles selection flowchart according to preferred reporting items for systematic reviews and meta-analyses (PRISMA)
Bild vergrößern
Table 1
Characteristics of the included studies
STUDY
Year
Patients
(no.)
Country
Treatment type
Details
Success
(no.)
Leaks localizations
Time from surgery to leak
Complications
(no.)
Aburajab et al
2017
5
USA
Stent, Clips
FCSEMS, OTSC
5
-
-
2
Alamdari et al
2018
8
Iran
Stent
FCSEMS
7
GOJ = 7; distal = 1
Acute = 1; early = 6; chronic = 1
1
Assalia et al
2018
24
Israel
Sealant
Fibrine glue
23
GOJ = 24; distal = 0
Acute = 10; early = 9; chronic = 5
0
Baretta et al
2015
9
Brazil
Septotomy
Endoscopic stricturotomy
8
GOJ = 9; distal = 0
-
1
Archid et al
2020
8
Germany
EVT
Endoscopic vacuum therapy
7
GOJ = 7; distal = 1
Acute = 0; early = 8; chronic = 0
1
Manta et al
2016
6
Italy
Stent, clips
SEMS, OTSC
3
-
Acute = 3; early = 3; chronic = 0
-
Bona et al
2020
8
Italy
Stent, clips
Esophageal mega stent, OTSC
7
GOJ = 8; distal = 0
Acute = 0; early = 7; chronic = 1
1
Bashah et al
2020
73
Qatar
Stent, clips
Double-pigtail stent, OTSC
66
-
-
2
Yimcharoen et al
2011
6
USA
Stent
Fully and partially covered SEMS
4
-
Acute = 2; early = 0; chronic = 4
2
Aljahdli et al
2021
11
Saudi Arabia
Stent
FCSEMS
9
GOJ = 10; distal = 1
Acute = 2; early = 8; chronic = 1
5
Almadi et al
2018
64
Saudi Arabia
Stent
Fully and partially covered SEMS
60
GOJ = 64; distal = 0
Acute = 32; early = 29; chronic = 3
9
Boerlage et al
2018
13
Netherlands
Stent
FCSEMS
9
-
-
3
Périssé et al
2015
23
Brazil
Stent
FCSEMS
19
GOJ = 23; distal = 0
-
6
Alazmi et al
2014
17
Kuwait
Stent
SEMS, SEPS
13
 
Acute = 10; early = 6; chronic = 1
6
Al-Kurd et al
2018
14
Israel
Stent, clips
OTSC, non-OTSC clip, stent
6
-
-
-
Billman et al
2021
23
Germany
Stent
Esophageal mega stent, FCSEMS
16
-
-
7
Archid et al
2021
27
Germany
Stent, EVT
SEMS, EVT
17
GOJ = 26; distal = 1
Acute = 7; early = 20; chronic = 0
12
Balagué et al
2021
44
Spain
Stent, clips, sealant
SEMS, OTSC, TTS, sealant
28
GOJ = 39; distal = 5
Acute = 18; early = 26; chronic = 0
25
Caiazzo et al
2020
100
France
Stent
Double-pigtail stent, covered stent
4
GOJ = 79; distal = 21
Acute = 60; early = 33; chronic = 7
-
Benosman et al
2018
26
France
Stent, clips
Double-pigtail stent, SEMS, TTS, OTSC
23
GOJ = 26; distal = 0
-
12
Balagué et al
2020
42
Spain
Stent
Fully and partially covered SEMS
23
-
-
18
Fuentes-Valenzuela et al
2021
5
Spain
Stent
Double-pigtail stent
5
GOJ = 5; distal = 5
Acute = 3; early = 1; chronic = 1
1
Garofalo et al
2017
11
Canada
Stent, clips
Double-pigtail stent, SEMS, OTSC
11
GOJ = 11; distal = 0
Acute = 2; early = 8; chronic = 1
2
Hany et al
2021
44
Egypt
Stent
Covered SEMS
33
GOJ = 35; distal = 9
Acute = 0; early = 44; chronic = 0
11
Diaz et al
2020
5
USA
Septotomy
Endoscopic stricturotomy
5
GOJ = 5; distal = 0
Acute = 1; early = 4; chronic = 0
-
Foo et al
2017
6
Australia
Stent
Double-pigtail stent, FCSEMS
6
GOJ = 6; distal = 0
-
-
Ferraz et al
2021
21
Brazil
Stent
SEMS
20
GOJ = 19; distal = 2
Acute = 5; early = 16; chronic = 0
1
Casella et al
2009
6
Italy
Stent, sealant
Covered stent, glue
6
GOJ = 5; distal = 1
Acute = 3; early = 3; chronic = 0
0
Donatelli et al
2015
67
France
Stent
Double-pigtail stent
59
GOJ = 56; distal = 11
Acute = 26; early = 32; chronic = 9
6
Guzaiz et al
2016
12
Saudi Arabia
Stent
Covered SEMS
12
-
-
6
de Moura et al
2019
37
Brazil
Stent
Covered SEMS
29
GOJ = 35; distal = 2
Acute = 10; early = 27; chronic = 0
4
Fishman et al
2015
26
Israel
Stent
SEMS
17
GOJ = 25; distal = 1
Acute = 1; early = 17; chronic = 8
5
Donatelli et al
2014
21
France
Stent
Double-pigtail stent
12
GOJ = 19; distal = 2
-
2
Donatelli et al
2021
275
France
Stent
SEMS, double-pigtail stent
246
-
-
-
Csendes et al
2010
16
Chile
Endoscopic treatment
-
16
GOJ = 14; distal = 2
Acute = 7; early = 9; chronic = 0
1
Christophorou et al
2015
110
France
Stent, clips, sealant
FCSEMS, PCSEMS, double-pigtail stent, OTSC, glue
81
-
Acute = 50; early = 42; chronic = 18
18
Gonzalez et al
2015
15
France
Stent
Mega stent
12
-
-
-
Gonzalez et al
2018
44
France
Stent
Double-pigtail stent
37
-
Acute = 3; early = 33; chronic = 8
11
El-Sayes et al
2017
27
Egypt
Stent
Covered SEMS
23
-
-
-
Lazzarin et al
2020
5
Italy
Stent
Double-pigtail stent
5
GOJ = 5; distal = 0
Acute = 3; early = 2; chronic = 0
0
Mahadev et al
2017
9
USA
Septotomy
Endoscopic stricturotomy
6
GOJ = 9; distal = 0
-
0
Mohammad et al
2019
8
Egypt
Stent
Mega stent
7
GOJ = 5; distal = 3
Acute = 4; early = 4; chronic = 0
1
Klimczak et al
2018
14
Poland
Stent
Mega stent
10
GOJ = 14; distal = 0
Acute = 1; early = 12; chronic = 1
9
Krishnan et al
2019
16
USA
Stent
SEMS
15
-
-
2
Talbot et al
2017
21
Australia
Stent, clips
FCSEMS, PCSEMS, TTS, OTSC
18
-
-
3
Leenders et al
2013
6
Netherlands
Stent
FCSEMS
5
GOJ = 3; distal = 3
Acute = 3; early = 3; chronic = 0
2
Moon et al
2015
15
USA
Stent, clips, sealant
SEMS, TTS, fibrine glue
14
GOJ = 15; distal = 0
Acute = 3; early = 9; chronic = 3
-
Lamb et al
2020
5
USA
Stent, endoscopic suturing
-
5
-
Acute = 0; early = 4; chronic = 1
1
Pequignot et al
2012
25
France
Stent
Double-pigtail stent, covered stent
19
GOJ = 19; distal = 6
Acute = 14; early = 11; chronic = 0
9
Mercky et al
2015
18
France
Clips
OTSC, non-OTSC clip, stent
18
-
Acute = 0; early = 5; chronic = 13
6
Leeds et al
2016
9
USA
EVT
Endoscopic vacuum therapy
8
-
Acute = 1; early = 3; chronic = 4
2
Keren et al
2015
26
Israel
Clips
OTSC
21
GOJ = 22; distal = 4
Acute = 10; early = 15; chronic = 1
0
del Campo et al
2018
24
USA
Stent
SEMS
14
GOJ = 18; distal = 6
Acute = 5; early = 8; chronic = 9
10
Olmi et al
2020
66
Italy
Stent, clips
SEMS, double-pigtail stent, OTSC
63
GOJ = 53; distal = 13
Acute = 30; early = 30; chronic = 6
13
Mizrahi et al
2021
26
Israel
Stent, clips, sealant
SEMS, OTSC, fibrine glue
14
GOJ = 26; distal = 0
Acute = 11; early = 8; chronic = 6 (1 unknown)
26
Manos et al
2021
53
France
Stent, endoscopic suturing
Double-pigtail stent, stricturotomy
51
-
Acute = 19; early = 25; chronic = 9
-
Lorenzo et al
2018
100
France
Stent, clips
SEMS, double-pigtail stent, OTSC
86
GOJ = 89; distal = 11
Acute = 44; early = 56; chronic = 0
68
Orive-Calzada et al
2014
11
Spain
Stent
SEMS
8
-
-
-
Juza et al
2015
5
USA
Stent
SEMS
5
GOJ = 3; distal = 2
Acute = 4; early = 1; chronic = 0
-
Murino et al
2015
55
Belgium
Stent
SEMS
42
-
-
-
Nimeri et al
2016
14
Arab Emirates
Stent
SEMS
14
GOJ = 13; distal = 1
Acute = 11; early = 1; chronic = 2
-
Spyropoulos et al
2012
8
Greece
Stent, sealant
SEMS, fibrine glue
8
GOJ = 8; distal = 0
-
4
Corona et al
2013
6
Italy
Stent
SEMS
3
-
-
1
Vix et al
2015
7
Taiwan
Stent
SEMS
2
GOJ = 7; distal = 0
-
2
Tan et al
2010
8
Australia
Stent
SEMS
4
GOJ = 8; distal = 0
Acute = 5; early = 3; chronic = 0
4
Nedelcu et al
2015
19
France
Stent
SEMS, double-pigtail stent
19
-
-
2
van Wezenbeek et al
2016
7
Netherlands
Stent, clips
SEMS, OTSC
6
GOJ = 7; distal = 0
-
6
Smallwood et al
2016
6
USA
EVT, clips
Endoscopic vacuum therapy, OTSC
6
-
-
0
Simon et al
2013
9
France
Stent
SEMS
7
GOJ = 9; distal = 0
Acute = 0; early = 6; chronic = 3
2
Shnell et al
2017
8
Israel
Endoscopic suturing
Septotomy
8
GOJ = 8; distal = 0
-
0
Southwell et al
2016
21
New Zealand
Stent
SEMS
15
GOJ = 15; distal = 6
Acute = 6; early = 12; chronic = 3
10
Quezada et al
2015
19
Chile
Stent
FCSEMS
18
GOJ = 19; distal = 0
Acute = 9; early = 6; chronic = 4
10
Rebibo et al
2016
20
France
Stent
SEMS, double-pigtail stent
19
-
Acute = 13; early = 4; chronic = 3
3
Siddique et al
2020
20
Kuwait
Stent
SEMS, double-pigtail stent
17
-
Acute = 0; early = 9; chronic = 11
2
Smith et al
2019
85
USA
Stent, clips, endoscopic suturing
SEMS, OTSC, endoscopic suturing
62
GOJ = 74; distal = 11
Acute = 13; early = 47; chronic = 25
34
Tringali et al
2017
10
Italy
Stent
FCSEMS
8
GOJ = 10; distal = 0
-
2
Shoar et al
2017
73
USA
Stent, clips
SEMS, OTSC
63
-
-
10
Sakran et al
2013
11
Israel
Stent, clips, sealant
SEMS, OTSC, Fibrine glue
5
-
-
-
Ward et al
2021
23
USA
Stent, EVT, clips
SEMS, endoscopic vacuum therapy, OTSC
23
-
-
-
FCSEMS fully covered self-expanding esophageal metal stents, OTSC over-the-scope clip, EVT endoscopic vacuum therapy, GOJ GastrOesophageal Junction, SEPS self-expandable plastic stent, TTS through-the-scope clip 

Quality Assessment and Publication Bias

Quality assessment of the included studies according to the Newcastle–Ottawa scale is reported in Table 2. The funnel plot showed symmetry (Supplementary File 2), confirmed by Egger’s regression test (p = 0.151), which indicates the absence of publication bias.
Table 2
Quality assessment of the included studies according to the Newcastle–Ottawa scale
STUDY
Selection
Sample size
Staple-line leak definition
Adjustment for confounders
Staple-line leak healing definition
Aburajab et al
High
High
Low
High
Low
Alamdari et al
High
High
Low
High
Low
Assalia et al
High
High
Low
High
Low
Baretta et al
High
High
Low
High
Low
Archid et al
High
High
Low
Low
Low
Manta et al
High
High
Low
Low
Low
Bona et al
High
High
Low
Low
Low
Bashah et al
High
High
Low
High
Low
Yimcharoen et al
High
High
Low
High
Low
Aljahdli et al
High
High
Low
High
Low
Almadi et al
High
High
Low
High
Low
Boerlage et al
Low
High
Low
High
Low
Périssé et al
High
High
Low
High
Low
Alazmi et al
High
High
Low
High
Low
Al-Kurd et al
High
High
Low
High
Low
Billman et al
Low
High
Low
High
Low
Archid et al
High
High
Low
High
Low
Balagué et al
High
High
Low
Low
Low
Caiazzo et al
High
High
Low
High
Low
Benosman et al
High
High
Low
Low
Low
Balagué et al
High
High
Low
Low
Low
Fuentes-Valenzuela et al
High
High
Low
high
Low
Garofalo et al
High
High
Low
Low
Low
Hany et al
High
High
Low
Low
Low
Diaz et al
High
High
Low
Low
Low
Foo et al
High
High
Low
High
Low
Ferraz et al
High
High
Low
High
Low
Casella et al
Low
High
Low
Low
Low
Donatelli et al
High
High
Low
Low
Low
Guzaiz et al
Low
High
Low
HIgh
Low
de Moura et al
High
High
Low
HIgh
Low
Fishman et al
High
High
Low
HIgh
Low
Donatelli et al
High
High
Low
Low
Low
Donatelli et al
High
High
Low
Low
Low
Csendes et al
High
High
Low
High
Low
Christophorou et al
High
High
Low
High
Low
Gonzalez et al
High
High
Low
Low
Low
Gonzalez et al
High
High
Low
Low
Low
El-Sayes et al
High
High
Low
High
Low
Lazzarin et al
High
High
Low
High
Low
Mahadev et al
High
High
Low
High
Low
Mohammad et al
High
High
Low
High
Low
Klimczak et al
High
High
Low
High
Low
Krishnan et al
High
High
Low
High
Low
Talbot et al
High
High
Low
High
Low
Leenders et al
High
High
Low
High
Low
Moon et al
High
High
Low
Low
Low
Lamb et al
High
High
Low
High
Low
Pequignot et al
High
High
Low
Low
Low
Mercky et al
High
High
Low
Low
Low
Leeds et al
High
High
Low
High
Low
Keren et al
High
High
Low
High
Low
del Campo et al
High
High
Low
High
Low
Olmi et al
High
High
Low
Low
Low
Mizrahi et al
High
High
Low
Low
Low
Manos et al
Low
High
Low
High
Low
Lorenzo et al
High
High
Low
Low
Low
Orive-Calzada et al
High
High
Low
High
Low
Juza et al
High
High
Low
High
Low
Murino et al
High
High
Low
High
Low
Nimeri et al
High
High
Low
High
Low
Spyropoulos et al
High
High
Low
High
Low
Corona et al
High
High
Low
High
Low
Vix et al
High
High
Low
High
Low
Tan et al
High
High
Low
Low
Low
Nedelcu et al
High
High
Low
High
Low
van Wezenbeek et al
High
High
Low
High
Low
Smallwood et al
High
High
Low
Low
Low
Simon et al
High
High
Low
High
Low
Shnell et al
Low
High
Low
High
Low
Southwell et al
High
High
Low
High
Low
Quezada et al
High
High
Low
High
Low
Rebibo et al
High
High
Low
Low
Low
Siddique et al
High
High
Low
High
Low
Smith et al
High
High
Low
High
Low
Tringali et al
High
High
Low
High
Low
Shoar et al
High
High
Low
High
Low
Sakran et al
Low
High
Low
High
Low
Ward et al
High
High
Low
low
Low
  
Risk of bias
Selection (representativeness of the sample)
Consecutive patients
Low
 
Non-consecutive patients
High
 
Not described
High
Sample size
Justified
Low
 
Not justified
High
Detection (staple-line leak definition)
Described
Low
 
Not described
High
Adjustment for confounders (outcomes reported according to treatment type or timing of treatment)
Adjusted for confounders
Low
 
No adjustment for confounders
High
Detection (staple-line leak healing definition)
Described
Low
 
No description
High

Success Rate of the Endoscopic Treatments

The endoscopic treatment of SLL showed an overall pooled success rate of 84.1% (95% CI, 79.59 to 88.22, Fig. 2) with evidence of high heterogeneity among the studies (I2 = 81.87%, Q = 575.97; p < 0.0001). Influence analysis indicated the robustness of this result, showing that, leaving each study out in turn, the summary estimate of the overall success rate varied between − 1.2% and + 0.41%.
Fig. 2
Overall pooled success rate of endoscopic treatments for staple-line leaks
Bild vergrößern
Thirteen studies [19, 22, 26, 28, 37, 40, 41, 43, 50, 59, 7274] reported data about the success rate of endoscopic treatments according to the line of treatment. As first- and second-line treatments, endoscopic methods achieved a success rate of 78.75% (95% CI, 63.78 to 91.07) and 79.12% (95% CI, 63.97 to 91.54), respectively, with no significant difference between the treatments (p = 0.172).
Twelve studies [18, 21, 22, 24, 29, 39, 40, 45, 47, 56, 62, 66] reported the treatment success rate according to the timing of treatment. Six studies [22, 37, 41, 43, 50, 59] reported a success rate of 78.1% (95% CI, 48.3 to 98.3) in the case of acute SLL. The success rate in the case of chronic leak was 74.5% (96% CI, 57.8 to 88.7), according to six studies [19, 22, 26, 40, 41, 43]. The success rate in the case of early leak was 84.5% (95% CI, 71.8 to 94.6), according to ten studies [19, 22, 26, 37, 40, 41, 43, 50, 59, 74]. Meta-regression analysis showed that the success rate of endoscopic treatment was independent of the timing of leak occurrence (p = 0.543). Also, meta-regression analysis showed that the success rate of the different endoscopic treatment methods was independent of the location of leaks (p = 0.053).
After the index endoscopic treatment, 22.62% (95% CI, 16.57 to 29.19) of the patients required an additional procedure according to 63 studies [2, 5, 1531, 3447, 5060, 6370, 7586]. A complication related to the endoscopic treatment was reported in 63 studies [7, 1517, 1925, 2738, 4045, 47, 5062, 6471, 75, 7779, 8289] with an incidence of 26.7% (95% CI, 21.5 to 32).

Efficacy of Different Endoscopic Treatments

In total, 70 studies reported the success rates specific to one or more endoscopic treatments.
Ten studies [18, 22, 24, 39, 45, 47, 62, 66, 85, 87] reported a pooled success rate of endoscopic clipping (OTSC or TTS) of 65.98% (95% CI, 41.32 to 87.68) as shown in Fig. 3. Double-pig tail drainage achieved a pooled SLL closure in 90.07% (95% CI, 73.99 to 99.66) of the patients, according to ten studies [23, 24, 27, 34, 40, 45, 47, 56, 62, 64] (Fig. 3). The success rate of endoscopic vacuum therapy was 90.2% (95% CI, 76.31 to 99.09) in four studies [17, 21, 42, 85] (Fig. 4). Three studies [60, 65, 70] reported data on the efficacy of septotomy, with a pooled efficacy observed in 88.25% (95% CI, 63.56 to 100) of the cases (Fig. 4). Sealant application showed a success in 56% (95% CI, 60.3 to 99.3) according to five studies [16, 22, 29, 39, 66] (Fig. 4).
Fig. 3
Pooled success rate of the endoscopic clipping (OTSC or TTS) and drainage by double pig tail
Bild vergrößern
Fig. 4
Pooled success rate of the endoscopic vacuum therapy, septotomy, and glue
Bild vergrößern
Thirty-three studies [15, 18, 2022, 24, 2931, 35, 36, 39, 40, 44, 45, 47, 48, 5558, 61, 62, 66, 68, 71, 72, 78, 79, 82, 83, 87, 90] reported data on the application of stents, with a pooled success rate of 79.8% (95% CI, 73.4 to 85.64) as shown in Fig. 5.
Fig. 5
Pooled success rate of the endoscopic stenting
Bild vergrößern
Meta-regression analysis showed a statistically significant association between the use of double pig tails and a higher success rate (p = 0.035). A similar trend was also observed for endoscopic vacuum therapy (p = 0.052).

Discussion

LSG is currently the most commonly performed bariatric procedure worldwide, accounting for up to 75% of the primary interventions in the USA [1, 2]. This popularity is because LSG involves only the stomach, avoiding anastomosis and, consequently, the risk of internal hernias during follow-up. It also preserves the pylorus, allowing normal gastric emptying and a less severe rebound hypoglycemia [1, 9193]. Another advantage is that, in case of serious complications, it can be converted into a bypass operation.
On the other hand, within the specific complications of LSG, SLL is the most serious, with highly related mortality [6]. The incidence of SLL after primary LSG varies in published series between 0.5 and 7% with a mean value of 2.5%, depending on surgical volume and the surgeon’s experience [4, 7, 9498]. More recent data show an SLL reduction of over 50%, from 2.5% to approximately 1.1% [4, 99]. However, these figures derived from the registers of the International Societies of Bariatric Surgery are likely underestimated. The ASMBS, evaluating several series of different experienced surgeons, reported a leak rate after LSG between 16 and 20% [4, 96]. Furthermore, the lack of anastomosis and the perceived technical simplicity of the procedure have encouraged many general surgeons to perform LSG in non-specialized bariatric centers. Complications from such cases are often not reported in international registries, leading to significant data loss [6].
The causes of SLL after LSG can be recognized as mechanical or ischemic reasons, both involving increased intraluminal pressure exceeding the strength of the tissue and/or staple line [4, 5]. The clinical and symptomatic appearance of the leak is often subtle; thus, a timely and appropriate treatment is essential to minimize inflammatory and septic complications. However, the patient’s immunoreactive attitude affects more than the therapeutic timing alone in determining the endogenous response. For these reasons, morbidity and mortality can develop despite the correct treatment of the SLL [4, 100].
The endoscopic management of this life-threatening complication has been attempted using several different therapeutic approaches. Unfortunately, the small sample sizes and heterogeneity of published series make direct comparisons unreliable. Many reports refer to patients undergoing multiple, sequential treatments—surgical or endoscopic—making interpretation even more complex [3, 22, 101]. Prospective randomized trials would provide the most reliable evidence, but such studies are unlikely due to practical and ethical limitations. Consequently, no universally accepted treatment algorithm currently exists.
For all these reasons, to address this problem, we conducted a systematic review of the literature and a meta-analysis with meta-regression analysis to identify the best endoscopic treatment of SLL after SG.
Our analysis highlights several key findings. First, we must understand that the endoscopic treatments seem to have similar outcomes as both first- and second-line therapy. This could be because the non-endoscopic first-line therapy (often a radiological drainage) does not modify the anatomic features of the SLL and does not compromise the outcomes of the endoscopic treatments, even if applied as second-line therapies in case of first-line therapy failure.
Second, success rates tend to decline in early, acute, and chronic leaks, although this trend does not reach statistical significance due to the limited number of studies reporting these data (n = 6). There is, indeed, a relationship between the timing of the leak and its success treatment rate due to the hardness of the tissue border of the leak: the harder and more callous the edge of the leak, the more difficult it is for endoscopic treatment to be successful [3, 22, 101].
Our findings confirm the superior performance of double-pigtail stents and dedicated mega-stents. This, probably, is because they do not promote direct closure of the leak, but favor healing by secondary intention, together with drainage, for double pig tails, or after radiological drainage, for mega-stents. Perhaps the favorable results of VAC therapy, which stimulates drainage and healing by secondary intention, should be interpreted in this direction.
The worst results, however, are obtained with glues and clips. This depends, mainly, on the dimensions of the leak because the use of biological glues is indicated in case of leaks of a few mm in diameter, anyway less of 1 cm [3, 22, 101], and these situations are typical of very few cases. The evidence on clips is less consistent, as many series pool results for over-the-scope clips (OTSC) and through-the-scope clips (TTSC), despite their differing efficacy. This depends on the dimension and on the timing of the leak, as we already said above. Finally, we must consider that the sleeve is a low-volume and high-pressure system between two functioning sphincters (cardia and pylorus). Thus, even modest increases in endoluminal pressure can exceed the holding force of the clips, leading to a treatment failure [3, 22, 101].
We focused our review on endoscopic modalities because they are recommended as the first-line, conservative approach for SLL; accordingly, we aimed to compare the relative effectiveness of these techniques to inform evidence-based selection within that initial step of care. Surgical management remains integral to a step-up algorithm and is reserved for situations in which non-operative/endoscopic strategies are inappropriate or have failed—namely hemodynamic instability, diffuse peritonitis, or suspected gastric ischemia requiring urgent operative source control; large, devitalized, or otherwise non-closable defects; undrainable or inaccessible collections and ongoing sepsis despite adequate endoscopic and radiologic drainage and refractory leaks after sequential endoscopic attempts, for which several published algorithms advocate early or salvage surgical repair.

Strengths and Limitations

The strength of the meta-analysis is represented by the high number of studies, which, on the one hand, encompasses all the endoscopic treatments described in the literature and, on the other hand, provides high statistical power, particularly for the meta-regression analyses.
The main limitation is represented by the fact that the vast majority of the included studies were retrospective, with intrinsic methodological limitations, and the observed success rates were derived from highly heterogeneous populations and treatment contexts. Such variability in study design, patient selection, and reporting standards inevitably affects the robustness of pooled estimates. Although statistical heterogeneity was systematically assessed and addressed through subgroup analyses, random-effects modeling, and meta-regression, residual heterogeneity cannot be fully eliminated and should be taken into account when interpreting the findings. Therefore, while our results highlight promising trends, they should not be regarded as conclusive evidence of interchangeability among techniques, but rather as an informed synthesis of the best available—yet imperfect—data. These constraints underscore the need for more rigorous future research. In a setting in which randomized trials are logistically and ethically difficult to perform, prospective multicenter registries with standardized definitions of outcomes, uniform leak classification, and clearly reported endpoints would provide more reliable evidence. Such efforts are essential to translate current evidence into reproducible algorithms that can be consistently applied in clinical practice.

Declarations

Competing interests

The authors declare no competing interests.
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Titel
Endoscopic Treatment of Staple-Line Leaks After Sleeve Gastrectomy in Patients with Obesity: Which One is the Best Option, if Any? A Systematic Review with Meta-Analysis and Meta-regression
Verfasst von
Giuseppe Galloro
Mariano Cesare Giglio
Alessia Chini
Rosa Maione
Matteo Pollastro
Rosa Vitale
Antonio Pisani
Mario Musella
Publikationsdatum
20.10.2025
Verlag
Springer US
Erschienen in
Obesity Surgery / Ausgabe 12/2025
Print ISSN: 0960-8923
Elektronische ISSN: 1708-0428
DOI
https://doi.org/10.1007/s11695-025-08294-6
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Laparoskopischer Eingriff/© RFBSIP / stock.adobe.com (Symbolbild mit Fotomodellen), Abdominelle laparoskopische Operation/© Игорь Гончаров / stock.adobe.com (Symbolbild mit Fotomodellen), OP-Vorbereitung einer Seniorin/© sturti / Getty Images / iStock (Symbolbild mit Fotomodellen)