1Gastroenterology Department, Centro Hospitalar São João, Porto, Portugal
2Faculty of Medicine of the University of Porto, Porto, Portugal
Copyright © 2023 Korean Society of Gastrointestinal Endoscopy
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Conflicts of Interest
The authors have no potential conflicts of interest.
Funding
None.
Author Contributions
Conceptualization: ERP; Data curation: all authors; Formal analysis: all authors; Investigation: all authors; Methodology: all authors; Supervision: ERP; Validation: ERP; Visualization: ERP; Writing–original draft: all authors; Writing–review and editing: all authors.
Technique | Study | Indication/study design | Participants | Technical and clinical success | Outcomes |
---|---|---|---|---|---|
Stent | van Boeckel et al. (2011)25 | Systematic review | 267 Patients (137 anastomotic leaks) | - No differences in clinical success (SEPS 84% vs. FC-SEMS 85% vs. PC-SEMS 86%, p=0.97) | - Stent migration was more frequent in SEPS group (SEPS 31% vs. FC-SEMS 26% vs. PC-SEMS 12%, p<0.001) |
- 159 (59.6%) SEPS | - No difference in tissue in- and overgrowth (SEPS 3% vs. FC-SEMS 7% vs. PC-SEMS 12%, p=0.68) | ||||
- 34 (12.7%) FC-SEMS | |||||
- 74 (27.7%) PC-SEMS | |||||
Dasari et al. (2014)23 | Systematic review | 340 Patients (181 anastomotic leaks) | - Technical success (SEMS 96.5% vs. SEPS 89.9%, p=0.025) | - SEMS (vs. SEPS) had lower risk of migration (11% vs. 27%, p=0.09) and endoscopic reintervention (5% vs. 22%, p=0.09) | |
- 117 (34.4%) SEMS | - Similar clinical success (86.2% vs. 86.2%) | - No differences in stent perforation or bleeding | |||
- 148 (43.5%) SEPS | |||||
- 70 (20.6%) SEPS/SEMS | |||||
- 5 (1.5%) BDS | |||||
Kamarajah et al. (2020)24 | Systematic review | 381 Patients | - Higher technical success with SEMS (99% vs. 85%, p<0.001) | - SEPS had higher migration rate (24% vs. 15%, p=0.034), perforation rate (0% vs. 2%, p=0.013) and stent erosion rate (25% vs. 3%, p=0.002) | |
- 282 (74%) SEMS | - No differences in clinical success (90% vs. 82%, p=0.058) | - No differences in bleeding rate | |||
- 82 (21.5%) SEPS | |||||
- 17 (4.5%) SEMS/SEPS | |||||
Rogalski et al. (2021)26 | Systematic review and meta-analysis | 493 Patients | - Overall leak/fistula closure rate: 89% | - Overall stent migration: 23% | |
- 344 (69.8%) SEMS after SG | - Leak closure rate in SG group: 92% | ||||
- 149 (30.2%) SEMS after GB | - Leak closure in GB group: 96% | ||||
OTSC | Vermeulen and Siersema (2019)28 | Systematic review | 41 Patients | Clinical success: 85% | AE rate: 5% |
Kobara et al. (2019 )27 | Systematic review and meta-analysis | 97 Patients | Clinical success: 66% | - OTSC-related AEs rate: 1.7% (26/1,517 cases) | |
- 0.59% OTSC AEs required surgery | |||||
Rogalski et al. (2021)26 | Systematic review and meta-analysis | 85 Patients | Overall leak/fistula closure rate: 67.1% | Only 3 AEs (migration, stenosis, tear) | |
EVT | Tavares et al. (2021)30 | Systematic review and meta-analysis | 532 Patients | Fistulous orifice closure rate: 81.6% | - Esophagectomy closure rate: 79.5% |
- Gastrectomy closure rate: 90% | |||||
- Overall stenosis rate: 12.5% (esophagectomy 15.9% vs. gastrectomy 9.2%) | |||||
EID | Donatelli et al. (2021)31 | Retrospective cohort study | 300 SG patients | Clinical success: 89.5% | - Peri-procedural endoscopy-related AEs: 4.5% (mainly bleeding) |
- Revisional surgery required: 10.5% | |||||
Suture | Sharaiha et al. (2016)29 | Retrospective cohort study | 20 Patients | - Immediate technical success: 90% | - No serious AEs |
- Long-term clinical success: 27% | - No differences between primary or rescue therapy (p=0.13) | ||||
- Suture <30 days of diagnosis was associated with long-term clinical success (44% vs. 0%, p=0.041) | |||||
Tissue sealants | Rogalski et al. (2021)26 | Systematic review and meta-analysis | 63 Patients | Fistula closure rate: 92.8%–100% | AEs: 12.5% (pain and fever) |
Study | Indication/study design | Participants | Clinical success | AEs/mortality | Conclusions |
---|---|---|---|---|---|
Farnik et al. (2015)34 | Retrospective cohort study | 106 Patients | Higher clinical success with OTSC (OTSC 85% vs. FC-SEMS 64%, p<0.05) | FC-SEMS 68% (mainly migration) vs. OTSC 8.8%, p<0.01 | - Mean leakage size was lower in patients who placed OTSC (7.1 vs. 12.6 mm, p<0.01) |
- 72 (69%) FC-SEMS | - Higher clinical success for OTSC if placed as primary treatment (70% vs. 40%, p<0.05) | ||||
- 34 (31%) OTSC | - OTSC had a lower treatment duration (25 vs. 41.1 days, p<0.001), lower AEs rate (8.8% vs. 68%) | ||||
Lorenzo et al. (2018)33 | Retrospective cohort study | 100 Patients | Primary efficacy rate: EID 86% vs. stents/tissue sealants/OTSC 63%, p=0.043 | Migration or peri-prosthetic ulcers in patients who placed stents: 50% | Higher clinical success if EID was the initial treatment (p=0.043) |
- 22 (22%) EID | |||||
- 77 (77%) stents/tissue sealants/OTSC | |||||
Scognamiglio et al. (2020)36 | Systematic review and meta-analysis | 274 Patients | EVT was associated with higher leak closure (OR, 3.14; 95% CI, 1.23 –7.98) | - No differences in short-term (OR, 0.69; 95% CI, 0.23–2.10) and major AEs (OR, 0.37; 95% CI, 0.11–1.24) | - EVT was associated with a higher leak closure rate, more endoscopic device changes, shorter treatment duration, and a lower mortality |
- 105 (38.3%) EVT | - Mortality was lower for EVT group (OR, 0.39; 95% CI, 0.18–0.83) | - No significant differences in short-term and major AEs | |||
- 169 (61.7%) stents | |||||
Tavares et al. (2021)30 | Systematic review and meta-analysis | 226 Patients | Higher closure with EVT (RD, 0.16; 95% CI, 0.05–0.27) | - No differences in AE rate (RD, -0.18, 95% CI, -0.41 to 0.05) | EVT seems to be more safe than stents for treatment of esophagectomy and total gastrectomy leaks |
- 74 (32.7%) EVT | - EVT had lower overall mortality risk (RD, -0.10; 95% CI, -0.18 to -0.02) | ||||
- 152 (67.3%) stents | |||||
Hallit et al. (2021)32 | Retrospective cohort study | 68 Patients | - Primary treatment success: EID 63% vs. stent 50% | Overall mortality rate: 3% | EID was associated with higher treatment success (100% [38/38] vs. 77% [23/30], p=0.002) |
- 38 (55.9%) EID | - Secondary treatment success: EID 32% vs. stent 17% | ||||
- 30 (44.1%) stents | |||||
do Monte Junior et al. (2021)35 | Systematic review and meta-analysis | 274 Patients: | - EVT was associated with a 21% increase of leak closure (RD, 0.21; 95% CI, 0.10–0.32) | EVT was associated with a 12% reduction in mortality (RD, 0.12; 95% CI, 0.03–0.21) and 24% reduction in AEs (RD, 0.24; 95% CI, 0.13–0.35) | EVT was superior in successful defect closure, mortality, and duration of treatment |
- 105 (38.3%) EVT | |||||
- 169 (61.7%) stents | |||||
Jung et al. (2022)37 | Retrospective cohort study | 62 Patients | - Overall treatment success: EID 100% vs. EVT 85.2% (p=0.03) | - No major AEs in both groups | - Both EID and EVT had high closure rates |
- 35 (56.5%) EID | - Primary treatment success rate: EID 91.4% vs. EVT 74.1% (p=0.09) | - EVT group: 2 patients (7.4%) died from multi-organ failure | - EVT provided a shorter treatment duration but required a higher number of procedures | ||
- 27 (43.5%) EVT |
Technique | Study | Indication/study design | Participants | Technical and clinical success | Outcomes |
---|---|---|---|---|---|
Stent | van Boeckel et al. (2011)25 | Systematic review | 267 Patients (137 anastomotic leaks) | - No differences in clinical success (SEPS 84% vs. FC-SEMS 85% vs. PC-SEMS 86%, p=0.97) | - Stent migration was more frequent in SEPS group (SEPS 31% vs. FC-SEMS 26% vs. PC-SEMS 12%, p<0.001) |
- 159 (59.6%) SEPS | - No difference in tissue in- and overgrowth (SEPS 3% vs. FC-SEMS 7% vs. PC-SEMS 12%, p=0.68) | ||||
- 34 (12.7%) FC-SEMS | |||||
- 74 (27.7%) PC-SEMS | |||||
Dasari et al. (2014)23 | Systematic review | 340 Patients (181 anastomotic leaks) | - Technical success (SEMS 96.5% vs. SEPS 89.9%, p=0.025) | - SEMS (vs. SEPS) had lower risk of migration (11% vs. 27%, p=0.09) and endoscopic reintervention (5% vs. 22%, p=0.09) | |
- 117 (34.4%) SEMS | - Similar clinical success (86.2% vs. 86.2%) | - No differences in stent perforation or bleeding | |||
- 148 (43.5%) SEPS | |||||
- 70 (20.6%) SEPS/SEMS | |||||
- 5 (1.5%) BDS | |||||
Kamarajah et al. (2020)24 | Systematic review | 381 Patients | - Higher technical success with SEMS (99% vs. 85%, p<0.001) | - SEPS had higher migration rate (24% vs. 15%, p=0.034), perforation rate (0% vs. 2%, p=0.013) and stent erosion rate (25% vs. 3%, p=0.002) | |
- 282 (74%) SEMS | - No differences in clinical success (90% vs. 82%, p=0.058) | - No differences in bleeding rate | |||
- 82 (21.5%) SEPS | |||||
- 17 (4.5%) SEMS/SEPS | |||||
Rogalski et al. (2021)26 | Systematic review and meta-analysis | 493 Patients | - Overall leak/fistula closure rate: 89% | - Overall stent migration: 23% | |
- 344 (69.8%) SEMS after SG | - Leak closure rate in SG group: 92% | ||||
- 149 (30.2%) SEMS after GB | - Leak closure in GB group: 96% | ||||
OTSC | Vermeulen and Siersema (2019)28 | Systematic review | 41 Patients | Clinical success: 85% | AE rate: 5% |
Kobara et al. (2019 )27 | Systematic review and meta-analysis | 97 Patients | Clinical success: 66% | - OTSC-related AEs rate: 1.7% (26/1,517 cases) | |
- 0.59% OTSC AEs required surgery | |||||
Rogalski et al. (2021)26 | Systematic review and meta-analysis | 85 Patients | Overall leak/fistula closure rate: 67.1% | Only 3 AEs (migration, stenosis, tear) | |
EVT | Tavares et al. (2021)30 | Systematic review and meta-analysis | 532 Patients | Fistulous orifice closure rate: 81.6% | - Esophagectomy closure rate: 79.5% |
- Gastrectomy closure rate: 90% | |||||
- Overall stenosis rate: 12.5% (esophagectomy 15.9% vs. gastrectomy 9.2%) | |||||
EID | Donatelli et al. (2021)31 | Retrospective cohort study | 300 SG patients | Clinical success: 89.5% | - Peri-procedural endoscopy-related AEs: 4.5% (mainly bleeding) |
- Revisional surgery required: 10.5% | |||||
Suture | Sharaiha et al. (2016)29 | Retrospective cohort study | 20 Patients | - Immediate technical success: 90% | - No serious AEs |
- Long-term clinical success: 27% | - No differences between primary or rescue therapy (p=0.13) | ||||
- Suture <30 days of diagnosis was associated with long-term clinical success (44% vs. 0%, p=0.041) | |||||
Tissue sealants | Rogalski et al. (2021)26 | Systematic review and meta-analysis | 63 Patients | Fistula closure rate: 92.8%–100% | AEs: 12.5% (pain and fever) |
Study | Indication/study design | Participants | Clinical success | AEs/mortality | Conclusions |
---|---|---|---|---|---|
Farnik et al. (2015)34 | Retrospective cohort study | 106 Patients | Higher clinical success with OTSC (OTSC 85% vs. FC-SEMS 64%, p<0.05) | FC-SEMS 68% (mainly migration) vs. OTSC 8.8%, p<0.01 | - Mean leakage size was lower in patients who placed OTSC (7.1 vs. 12.6 mm, p<0.01) |
- 72 (69%) FC-SEMS | - Higher clinical success for OTSC if placed as primary treatment (70% vs. 40%, p<0.05) | ||||
- 34 (31%) OTSC | - OTSC had a lower treatment duration (25 vs. 41.1 days, p<0.001), lower AEs rate (8.8% vs. 68%) | ||||
Lorenzo et al. (2018)33 | Retrospective cohort study | 100 Patients | Primary efficacy rate: EID 86% vs. stents/tissue sealants/OTSC 63%, p=0.043 | Migration or peri-prosthetic ulcers in patients who placed stents: 50% | Higher clinical success if EID was the initial treatment (p=0.043) |
- 22 (22%) EID | |||||
- 77 (77%) stents/tissue sealants/OTSC | |||||
Scognamiglio et al. (2020)36 | Systematic review and meta-analysis | 274 Patients | EVT was associated with higher leak closure (OR, 3.14; 95% CI, 1.23 –7.98) | - No differences in short-term (OR, 0.69; 95% CI, 0.23–2.10) and major AEs (OR, 0.37; 95% CI, 0.11–1.24) | - EVT was associated with a higher leak closure rate, more endoscopic device changes, shorter treatment duration, and a lower mortality |
- 105 (38.3%) EVT | - Mortality was lower for EVT group (OR, 0.39; 95% CI, 0.18–0.83) | - No significant differences in short-term and major AEs | |||
- 169 (61.7%) stents | |||||
Tavares et al. (2021)30 | Systematic review and meta-analysis | 226 Patients | Higher closure with EVT (RD, 0.16; 95% CI, 0.05–0.27) | - No differences in AE rate (RD, -0.18, 95% CI, -0.41 to 0.05) | EVT seems to be more safe than stents for treatment of esophagectomy and total gastrectomy leaks |
- 74 (32.7%) EVT | - EVT had lower overall mortality risk (RD, -0.10; 95% CI, -0.18 to -0.02) | ||||
- 152 (67.3%) stents | |||||
Hallit et al. (2021)32 | Retrospective cohort study | 68 Patients | - Primary treatment success: EID 63% vs. stent 50% | Overall mortality rate: 3% | EID was associated with higher treatment success (100% [38/38] vs. 77% [23/30], p=0.002) |
- 38 (55.9%) EID | - Secondary treatment success: EID 32% vs. stent 17% | ||||
- 30 (44.1%) stents | |||||
do Monte Junior et al. (2021)35 | Systematic review and meta-analysis | 274 Patients: | - EVT was associated with a 21% increase of leak closure (RD, 0.21; 95% CI, 0.10–0.32) | EVT was associated with a 12% reduction in mortality (RD, 0.12; 95% CI, 0.03–0.21) and 24% reduction in AEs (RD, 0.24; 95% CI, 0.13–0.35) | EVT was superior in successful defect closure, mortality, and duration of treatment |
- 105 (38.3%) EVT | |||||
- 169 (61.7%) stents | |||||
Jung et al. (2022)37 | Retrospective cohort study | 62 Patients | - Overall treatment success: EID 100% vs. EVT 85.2% (p=0.03) | - No major AEs in both groups | - Both EID and EVT had high closure rates |
- 35 (56.5%) EID | - Primary treatment success rate: EID 91.4% vs. EVT 74.1% (p=0.09) | - EVT group: 2 patients (7.4%) died from multi-organ failure | - EVT provided a shorter treatment duration but required a higher number of procedures | ||
- 27 (43.5%) EVT |
SEPS, self-expandable plastic stents; FC, fully covered; PC, partial covered; SEMS, self-expandable metal stents; BDS, biodegradable stents; SG, sleeve gastrectomy; GB, gastric bypass; OTSC, over-the-scope clip; AE, adverse event; EVT, endoscopic vacuum therapy; EID, endoscopic internal drainage.
AE, adverse event; FC-SEMS, fully covered self-expandable metal stents; OTSC, over-the-scope clip; EID, endoscopic internal drainage; EVT, endoscopic vacuum therapy; OR, odds ratio; CI, confidence interval; RD, risk difference.