OTSC System, OTSC Clips

OTSC®: Systematic review of 3025 patients demonstrates efficacy in GI hemorrhage, perforation, anastomotic leak and stent fixation at an overall technical success rate of 94.4 %

A systematic review of studies with at least five patients examinating OTSC application for any indication in the GI tract found 85 eligible articles with overall 3025 patients. Average clinical success rates were: 86.0 % for hemorrhage, 85.3 % for perforation, 55.8 % for chronic fistula, 72.6 % for anastomotic leaks, 92.8 % for defect closure following endoscopic resection, and 80.0 % for stent fixation. Procedural adverse events were reported in 2.1 %.

N. Bartell et al., University of Rochester Medical Center, Rochester NY, USA performed a systematic review aiming to determine the clinical success and adverse event rates of OTSC application comprising all indications. A thorough search of the literature was conducted in the Pubmed database for eligible articles. Case reports and case series with less than 5 patients were excluded. Articles were included from January 1, 2007 to January 15, 2020. The following terms were used to perform the literature search: “over-the-scope-clip”, “OTSC”, “endoscopic fistula closure”, “over-the-scope clip bleeding”, “stent fixation”, and “endoscopic perforation closure”.

Technical success was defined as successful deployment of the OTSC clip to the targeted lesion or defect. Clinical success was defined as complete and durable resolution of the respective defect, hemorrhage and/or stent fixation.

A total of 85 articles with overall 3025 patients met the inclusion criteria. Overall technical success rate was 94.4 %, overall clinical success rate was 78.4 %. Per-indication clinical success rates were: 1120/1303 (86.0 %) for GI hemorrhage; 399/468 (85.3 %) for perforation; 347/622 (55.8 %) for fistulae; 284/391 (72.6 %) for anastomotic leaks; 205/221 (92.8 %) for defect closure following endoscopic resection (e.g. following EMR or ESD); and 16/20 (80.0 %) for stent fixation.

Adverse events related to OTSC deployment were only reported in 64 of 85 studies (n = 1942 patients), with an overall adverse event rate of 2.1 % (40/1942). Surgical intervention despite OTSC placement was required in 4.7 % of patients (n = 143/3025).

The authors concluded that this systematic review confirms the safety and efficacy of the OTSC System in the management of GI hemorrhage, perforations, anastomotic leaks, defects created by endoscopic resections and for stent fixation.

Clinical efficacy of the over-the-scope clip device: A systematic review
Bartell N, Bittner K, Kaul V, Kothari TH, Kothari S
World J Gastroenterol 2020 June 28; 26(24): 3318-3516.