Clinical efficacy of the over-the-scope clip device: A systematic review

BACKGROUND The over-the-scope clip (OTSC) system has been increasingly utilized as a non-surgical option to endoscopically manage refractory gastrointestinal (GI) hemorrhage, perforations/luminal defects and fistulas. Limited data exist evaluating the efficacy and safety of OTSC. AIM To determine the clinical success and adverse event (AE) rates of OTSC across all GI indications. METHODS A PubMed search was conducted for eligible articles describing the application of the OTSC system for any indication in the GI tract. Any article or case series reporting data for less than 5 total patients was excluded. The primary outcome was the rate of clinical success. Secondary outcomes included: Technical success rate, OTSC-related AE rate and requirement for surgical intervention despite-OTSC placement. Pooled rates (per-indication and overall) were calculated as the number of patients with the event of interest divided by the total number of patients. RESULTS A total of 85 articles met our inclusion criteria (n= 3025 patients). OTSC was successfully deployed in 94.4% of patients (n= 2856/3025). The overall rate of clinical success (all indications) was 78.4% (n= 2371/3025). Per-indication clinical success rates were as follows: (1) 86.0% (1120/1303) for GI hemorrhage; (2) 85.3% (399/468) for perforation; (3) 55.8% (347/622) for fistulae; (4) 72.6% (284/391) for anastomotic leaks; (5) 92.8% (205/221) for defect closure following endoscopic resection (e.g., following endoscopic mucosal resection or endoscopic submucosal dissection); and (6) 80.0% (16/20) for stent fixation. AE's related to the deployment of OTSC were only reported in 64 of 85 studies (n= 1942 patients), with an overall AE rate of 2.1% (n= 40/1942). Salvage surgical intervention was required in 4.7% of patients (n= 143/3025). CONCLUSION This systematic review demonstrates that the OTSC system is a safe and effective endoscopic therapy to manage GI hemorrhage, perforations, anastomotic leaks, defects created by endoscopic resections and for stent fixation. Clinical success in fistula management appears limited. Further studies, including randomized controlled trials comparing OTSC with conventional and/or surgical therapies, are needed to determine which indication(s) are the most effective for its use.