Abstract
Objectives
Colorectal endoscopic submucosal dissection (ESD) remains challenging because of technical difficulties, long procedure time, and high risk of adverse events. To facilitate colorectal ESD, we developed traction-assisted colorectal ESD using a clip-and-thread (TAC-ESD) and conducted a randomized controlled trial to evaluate its efficacy.
Methods
Patients with superficial colorectal neoplasms (SCNs) ≥20 mm were enrolled and randomly assigned to the conventional-ESD or TAC-ESD group. SCNs ≤50 mm were treated by two intermediates, and SCNs >50 mm were treated by two experts. The primary endpoint was the procedure time. Secondary endpoints were the TAC-ESD success rate (sustained application of the clip-and-thread until the end of the procedure), self-completion rate by the intermediates, and adverse events.
Results
Altogether, 42 SCNs were analyzed in each ESD group (conventional and TAC). The procedure time (median [range]) for the TAC-ESD group was significantly shorter than that for the conventional-ESD group (40 [11–86] min vs. 70 [30–180] min, respectively; P<0.0001). The success rate of TAC-ESD was 95% (40/42). The intermediates' self-completion rate was significantly higher for the TAC-ESD group than for the conventional-ESD group (100% [39/39] vs. 90% [36/40], respectively; P=0.04). Adverse events included one intraoperative perforation in the conventional-ESD group and one delayed perforation in the TAC-ESD group.
Conclusions
TAC-ESD reduced the procedure time and increased the self-completion rate by the intermediates. (UMIN000018612)
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