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Comparative Study
Journal Article
Randomized Controlled Trial
Efficacy of traction-assisted colorectal endoscopic submucosal dissection using a clip-and-thread technique: A prospective randomized study.
BACKGROUND AND AIM: 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 (SCN) ≥20 mm were enrolled and randomly assigned to the conventional-ESD group or to the TAC-ESD group. SCN ≤50 mm were treated by two intermediates, and SCN >50 mm were treated by two experts. Primary endpoint was procedure time. Secondary endpoints were 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 SCN were analyzed in each ESD group (conventional and TAC). 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). 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.
CONCLUSION: Traction-assisted colorectal endoscopic submucosal dissection reduced the procedure time and increased the self-completion rate by the intermediates (UMIN000018612).
METHODS: Patients with superficial colorectal neoplasms (SCN) ≥20 mm were enrolled and randomly assigned to the conventional-ESD group or to the TAC-ESD group. SCN ≤50 mm were treated by two intermediates, and SCN >50 mm were treated by two experts. Primary endpoint was procedure time. Secondary endpoints were 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 SCN were analyzed in each ESD group (conventional and TAC). 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). 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.
CONCLUSION: Traction-assisted colorectal endoscopic submucosal dissection reduced the procedure time and increased the self-completion rate by the intermediates (UMIN000018612).
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