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DOI: 10.1055/a-2591-7104
Feasibility of traction-band-assisted endoscopic closure for mucosal defects after colorectal endoscopic submucosal dissection: a multicenter, prospective, single-arm, pilot study
Clinical Trial: Registration number (trial ID): UMIN000047953, Trial registry: UMIN Japan (http://www.umin.ac.jp/english/), Type of Study: Prospective, Single-arm, Multi-Center Study
Background and Aims: The complete closure of mucosal defects following colorectal endoscopic submucosal dissection (ESD) is often challenging. We invented a traction-band-assisted endoscopic closure (TBEC) technique using clips with an integrated traction band. We aimed to evaluate the feasibility of TBEC for closing mucosal defects following colorectal ESD. Methods: This multicenter, prospective, single-arm, pilot study was conducted at three institutions from June 2022 to March 2023. Thirty-four patients with colorectal neoplasms measuring 20-50 mm scheduled for ESD were enrolled. TBEC was performed at each mucosal defect after ESD. The primary outcome was the complete closure rate by TBEC. Secondary outcomes included the number of clips used, procedure time, and adverse events (AEs). Results: TBEC yielded a 100.0% [95% confidence interval: 89.8%-100.0%] complete closure rate, with a median closure time of 14.5 min (interquartile range: 12.9). The median number of clips used was 10.0 (3.3). One case of delayed bleeding and one of post-ESD coagulation syndrome (both 2.9% [0.5%-14.9%]) occurred following TBEC. Conclusions: This study demonstrated the feasibility of TBEC for closing mucosal defects following colorectal ESD. TBEC is a simple and easily applicable technique for endoscopic closure. Further studies are required to evaluate its efficacy in reducing delayed AEs.
Publication History
Received: 01 December 2024
Accepted after revision: 18 April 2025
Accepted Manuscript online:
22 April 2025
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