Over-The-Scope Clip for the Treatment of Gastrointestinal Tract Fistulae: Single-Center Experience with 58 Applications

Abstract

Introduction: The over-the-scope clip system, OTSC (Ovesco Endoscopy, Tübingen, Germany) is an advanced clipping device developed for closure of luminal gastrointestinal (GI) defects, such as gastrointestinal fistulae. The aim of this study was to evaluate the clinical outcomes of patients with gastrointestinal tract fistulae treated with the OTSC. Methods: Observational, open-label, retrospective, single-arm case series conducted at a tertiary care endoscopy unit. This study involved 58 clip applications in 37 patients (median age 52 years [range 30-86], 17 women) with diverse gastrointestinal fistulae. Success was divided into deployment and clinical. Deployment success was defined as the ability to deploy the device, while clinical success was defined as the ability to resolve the clinical situation. Results: A total of 58 clips were applied in 37 patients. The range of indications included gastro-cutaneous (n=22), tracheo-oesophageal and/or esophago-pleural fistulae (n=20), gastro-colic (n=5), gastroperitoneal (n=4), enterocutaneous (n=4), and recto-vaginal (n=3) fistulae. The overall deployment success rate for the OTSC device was 96.6% (56 out of 58 applications). The overall clinical success rate was 84.5% (49 of 58 applications). The clinical success was highest in gastrocutaneous fistulae (95.2%), whereas the clinical success for TE fistulae was lowest (50%). Complications related to the application of the clipping device included minor bleeding (n=2). There were no further complications related to endoscopy or sedation. Conclusion: To our knowledge, this is the largest single-center experience using the OTSC system in the closure of gastrointestinal leaks and fistulae. The OTSC system is a useful device in a variety primary and iatrogenically-induced endoluminal GI tract disorders including fistulae. The clinical success rates for closure of gastrocutaneous fistulae was highest, whereas the success rates for tracheoesophageal fistulae closure was lowest.