P0635 - Clinical Outcomes of Endoscopic Suturing in Gastrointestinal Fistulas, Leaks, Perforations and Mucosal Defects: A Systematic Review and Meta-Analysis

Babu Mohan, MD¹, Shahab R. Khan, MBBS², Deepak Madhu, MD, MRCP, DM³, Lena Kassab, MD, MBA⁴, Saikiran Jonnadula, MD⁵, Saurabh Chandan, MD⁶, Antonio Facciorusso, MD, PhD⁷, Douglas Adler, MD^8
1University of Utah School of Medicine, Salt Lake City, UT; ²Brigham & Women's Hospital, Harvard Medical School, Boston, MA; ³Caritas Hospital, Kottayam, Kerala, India; ⁴Mayo Clinic, Rochester, MN; ⁵Saint Vincent Hospital, Cleveland, OH; ⁶Creighton University School of Medicine, Omaha, NE; ⁷University of Foggia, Foggia, Puglia, Italy; ⁸Center for Advanced Therapeutic Endoscopy, Salt Lake City, UT

Introduction: Gastrointestinal (GI) defects like fistulae, leaks, perforations are well known causes for significant patient morbidity and/ or mortality. Accidental perforation during endoscopy procedures like colonoscopy continue to be one of the most feared adverse events. Sometimes mucosal defects are intentionally created as part of the procedure, like in per-oral endoscopic myotomy (POEM). Traditional methods of closing such defects have employed endo-clips and over the scope clip. Occasionally, the size of the defect poses a limitation to successful containment of the defect by clips alone. The OverStitch device has enabled endoscopic suturing and studies have reported on its clinical outcomes. In this study, we present a meta-analysis of the clinical outcomes of endosuturing in GI defects.

Methods: Multiple databases including Medline, Embase, Scopus were searched from inception to May 2021, and studies were gathered that reported on the clinical outcomes of endosuturing in GI defects like fistula, leak, and perforation. Outcomes assessed were the technical and clinical success, along with the adverse events. Standard meta-analysis methodology was followed using the random-effects model and heterogeneity was assessed by means of I²% and 95% prediction interval statistics.

Results: Five studies (149 patients) were included in the final analysis. All studies used the OverStitch endoscopic suturing device. The GI defects treated included fistulae, leaks, perforations and others. Apart from cumulative pooled rates, we also categorized the defects as follows: Fistulae/ leaks; perforations, and other mucosal defects. The size of the GI defect ranged from 5.6mm to 50mm. The pooled technical success for any GI defect was 92.7% (95%[84.4-96.8]), clinical success was 67.9%[59.2-75.5], and adverse events was 6.9%[3.8-12.5]. The pooled clinical success for perforations was 89.5%[73.8-96.3], wheres for fistulae/ leaks was 60.4%[50.1-69.9]. Table-1.

Discussion: Despite the high pooled technical success of endosuture for any GI defect and excellent pooled clinical success for GI perforations, the clinical success for fistula/leak seems low (60.4%). Therefore, this meta-analysis seems to suggest that endosuture might be a well suited treatment option for GI perforations. Future studies are warranted to further evaluate the entity of GI fistulae/ leaks and the clinical parameters that might predict a successful clinical with endosuture device.

Study Outcomes	Pooled rate (95% Confidence interval)	Heterogeneity I2%; 95% Prediction interval
Technical success
Any GI defect	92.7% (84.4-96.8) 8 datasets	70%; 29 to 99
Fistula/ Leak	89% (40.8-99) 3 datasets	89%; 1 to 99
Perforation	93.1% (78.8-98) 3 datasets	0%; 1 to 99
Other mucosal defects	93.1% (78.9-98) 2 datasets	0%; -NA-
Clinical success
Any GI defect	67.9% (59.2-75.5) 8 datasets	52%; 30 to 91
Fistula/ Leak	60.4% (50.1-69.9) 3 datasets	0%; 10 to 95
Perforation	89.5% (73.8-96.3) 3 datasets	0%; 1 to 99
Other mucosal defects	86.5% (64.8-95.7) 2 datasets	0%; -NA-
Adverse events
Any GI defect	6.9% (3.8-12.5) 8 datasets	0%; 3 to 14
Fistula/ Leak	7.1% (3.2-15) 3 datasets	0%; 1 to 94
Perforation	8.8% (2.9-24.2) 3 datasets	0%; 1 to 99
Other mucosal defects	3% (0.4-18.5) 2 datasets	0%; -NA-
GI: gastrointestinal, NA: not applicable

Table: Table-1: Summary of pooled rates


Disclosures:
Babu Mohan indicated no relevant financial relationships.
Shahab Khan indicated no relevant financial relationships.
Deepak Madhu indicated no relevant financial relationships.
Lena Kassab indicated no relevant financial relationships.
Saikiran Jonnadula indicated no relevant financial relationships.
Saurabh Chandan indicated no relevant financial relationships.
Antonio Facciorusso indicated no relevant financial relationships.
Douglas Adler: Boston Scientific – Consultant.


Babu Mohan, MD¹, Shahab R. Khan, MBBS², Deepak Madhu, MD, MRCP, DM³, Lena Kassab, MD, MBA⁴, Saikiran Jonnadula, MD⁵, Saurabh Chandan, MD⁶, Antonio Facciorusso, MD, PhD⁷, Douglas Adler, MD⁸. P0635 - Clinical Outcomes of Endoscopic Suturing in Gastrointestinal Fistulas, Leaks, Perforations and Mucosal Defects: A Systematic Review and Meta-Analysis, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.