A multicenter, single-blind randomized controlled trial of endoscopic clipping closure for preventing post-ESD coagulation syndrome
Gastrointestinal Endoscopy Dec 06, 2019
Nomura S, Shimura T, Katano T, et al. - Via performing a multicenter, single-blind randomized controlled trial (RCT), researchers investigated the utility of endoscopic clipping closure to prevent post-ESD coagulation syndrome (PECS) and delayed perforation (PECS/DP). They randomly allocated prospectively enrolled patients undergoing colorectal ESD to endoscopic clipping closure and nonclosure after ESD, stratifying by institution and tumor size. CT scan was performed on all participants after ESD. They defined PECS as a visual analog scale (VAS) ≥ 30 mm, a raise of VAS ≥ 20 mm from baseline, body temperature ≥ 37.5ºC or white blood cells ≥ 10,000/μL after colorectal ESD. PECS accompanied by extraluminal air defined DP. As conditional power with superiority was lower than the preplanned futility limit this trial was terminated by recommendation of the independent data and safety monitoring committee at the planned interim analysis. Finally, analysis of 155 patients was done. The nonclosure group had PECS/DP’s rate of 16 (95 % confidence interval [CI], 8%-23%) and the closure group had PECS/DP’s rate of 24. Findings do not support performing endoscopic clipping closure for reducing the high incidence of PECS/DP after colorectal ESD.
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