Efficacy of Over-the-Scope Clip (OTSC) for the Management of Perforations, Leaks, and Fistulas: A Systematic Review and Pooled Analysis of Published Literature

Abstract

Introduction: Over the scope clip (OTSC) offers a non-operative management option for perforations, leaks and fistulas in the gastrointestinal tract. Since there are no published large scale studies using OTSC, we performed a systematic review and pooled analysis of published literature to derive efficacy rates of OTSC for the management of perforations, leaks and fistulas. Methods: An electronic database search was conducted (Medline, Embase, Google Scholar and Cochrane) for eligible articles (case reports, case series, observational or cohort studies) using OTSC (Ovesco, Germany) for cases of gastrointestinal perforation, post-surgical anastomotic leak and fistula. The primary outcome was: durable clinical success rate (% of patients who had closure of the defect at the end of the study). Secondary outcomes were: primary technical success (% of patients who had successful OTSC placement) and primary clinical success (% of patients with successful initial closure of defect after OTSC placement). Pooled rates were expressed as proportions of events over total patients with 95% confidence limits and heterogeneity was assessed using I2. Results: A total of 17 studies were determined where OTSC was used for perforation management (175 patients, 45% males, average age 64.1 years). The primary technical success rate was 95.8% (93%-98.7%, I2=0%, p=0.7) and the durable clinical success rate was 90.9% (86.8%-95.1%, I2=0%, p=0.88). Among 13 studies, where OTSC was used for closure of post-surgical anastomotic leaks (90 patients,68% males, average age 62.2 years), primary technical success was achieved in 89.9% (84.2%-95.6%, I2=0%, p=0.49) patients with primary clinical success in 84.8% (78%-91.6%, I2=0%, p=0.46) patients and durable success was noted in 80.7% (72.2%-89.2%, I2=15.7%, p=0.29) patients. Among 23 studies where OTSC was used for fistula closure (334 patients, 43% males, average age 60 years), primary technical success was achieved in 85.6% (80.2%-91.1%, I2=52%, p=0.002) patients with a primary clinical success rate of 77.1% (70%-84.3%, I2=59%, p<0.001) and durable clinical success in 66.6% patients (57.2%-76.1%, I2=68%, p<0.001). Conclusion: Perforations in the GI-tract have been generally managed by surgeons but appear to be amenable to endoscopic closure. TOTSC offers an effective non-surgical option for the closure of GI luminal defects with durable clinical success and technical success being the highest in perforations followed by anastomotic leaks and fistulas respectively.511 Figure 1 No Caption available.