A multicenter, single-blind randomized controlled trial of endoscopic clipping closure for preventing post-ESD coagulation syndrome
Abstract
BACKGROUND AND AIMS
Post-ESD coagulation syndrome (PECS) occasionally occurs after colorectal endoscopic submucosal dissection (ESD), presenting with localized abdominal pain and inflammation. We conducted a randomized controlled trial (RCT) to assess the usefulness of endoscopic clipping closure to prevent PECS and delayed perforation (PECS/DP).
METHODS
This is a multicenter, single-blind RCT. Prospectively enrolled patients undergoing colorectal ESD were randomly allocated to endoscopic clipping closure and nonclosure after ESD, stratifying by institution and tumor size. All participants received computed tomography scan after ESD. PECS was defined as visual analogue 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. DP was defined as PECS accompanied by extraluminal air. The pre-planned sample size was 320 patients, and the primary endpoint was the rate of PECS/DP.
RESULTS
At the planned interim analysis, this trial was terminated by recommendation of the independent data and safety monitoring committee because conditional power with superiority was lower than the preplanned futility limit. Finally, 155 patients were analyzed. PECS/DP's rate was 16 (95 % confidence interval [CI], 8%-23%) in the nonclosure and 24 (95% CI, 14%-34%) in the closure groups, respectively (P = 0.184). All DP cases were within minor criteria, and all PECS/DP patients were conservatively managed without surgical…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 320 participants or records.
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