Performance of the OTSC System in the endoscopic closure of gastrointestinal fistulae - a meta-analysis

Abstract

Background: Conventional endoscopic treatment options for closure of gastrointestinal fistulae are impaired by several limitations and therefore yield high rates of recurrence. Aim of the study is the evaluation of the primary-technical and secondary-clinical success rates in closure of gastrointestinal fistulae by means of the OTSC System. Design/Methods: The database Medline was systematically searched for primary research on the evaluation of the OTSC System in closure of gastrointestinal fistulae. Appraisal of studies for inclusion and data extraction were performed independently by two reviewers using an a priori determined data extraction grid. Results: A total of 19 primary research articles were identified. The examined studies comprised case reports as well as case series and clinical single-arm studies (n = 7) with a limited number of participants. Reviewed studies revealed a high rate of procedural success (mean 84.6%; 95% confidence interval 66.6 to 93.8%) and durable clinical success (mean 69.0%; 95% confidence interval 51.8 to 82.2%). Failed attempts and incomplete closures were mainly ascribed to the challenging effort of treating highly fibrotic chronic fistulae. Conclusion: Endoscopic closure of gastrointestinal fistulae by means of the OTSC System is a safe and effective method.

Key words::

• Flexible endoscopy
• gastrointestinal fistula
• Over-The-Scope-Clip
• OTSC
• Nitinol

Declaration of interest: Timo Weiland and Marion Fehlker are employees of novineon CRO, a contract research organization. novineon CRO received funding from Ovesco Endoscopy to support this systematic literature study. Thomas Gottwald and Marc Schurr hold management position in Ovesco Endoscopy AG.