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Pooled durable clinical success proportions of OTSC use were 87.5 % in hemorrhage, 81.4 % in acute leaks/perforations and 63.0 % in chronic leaks/fistulae
Since its market launch in 2007, the OTSC System has been the object of intensive clinical research. Weiland T et al.,Tuebingen, performed a systematic collection of all data for post-market clinical follow-up (PMCF) aiming to systematically assess efficacy and safety of the OTSC.
The PMCF database was systematically searched for clinical data on OTSC therapy of GI hemorrhage (H), acute leaks/perforations (AL) and chronic leaks/fistulae (CL). Major outcomes were successful clip application and durable hemostasis/closure of defects.
457 publications were reviewed. 58 articles comprising 1868 patients fulfilled criteria to be included in the analysis. These consisted of retrospective analyses, prospective observational trials, one randomized-controlled trial (STING) and one quasi-controlled study (FLETRock). The pooled proportion analysis revealed high overall proportions of technical success: H – mean 93.0 % [95 % CI 90.2 – 95.4], AL-mean 89.7 % [95 % CI 85.9 – 92.9] and CL – mean 83.8 % [95 % CI 76.9 – 89.7]. Pooled durable clinical success proportions were: H – mean 87.5 % [95 % CI 80.5 – 93.2], AL – mean 81.4 % [95 % CI 77.0 – 85.3] and CL – mean 63.0 % [95 % CI 53.0 – 72.3].
By pooling all clinical data gained, the authors concluded that OTSC application in GI hemorrhage and closure of GI lesions is safe and effective in real clinical use.
Efficacy of the OTSC System in the treatment of GI bleeding and wall defects: a PMCF meta-analysis.
Weiland T, Rohrer S, Schmidt A, Wedi E, Bauerfeind P, Caca K, Khashab MA, Hochberger J, Baur F, Gottwald T, Schurr MO.
Minimally Invasive Therapy & Allied Technologies, DOI: 10.1080/13645706.2019.1590418.