Efficacy of a novel one-step knife compared to conventional knife for colorectal endoscopic submucosal dissection: a prospective multicenter randomized controlled trial.

Abstract

Purpose: For the treatment of advanced colorectal neoplasms, colon endoscopic submucosal dissection (ESD) is a crucial technique, although it is time-consuming. The purpose of this study was to evaluate the efficacy of a recently developed one-step knife (OSK) in colon ESD and compare its performance with that of a conventional knife (CK).

Methods: Between July 2020 and November 2021, patients scheduled to undergo colorectal ESD were randomly assigned to either the OSK group or the CK group. The primary outcome was the total submucosal injection time. Additionally, total procedure time, treatment outcomes, adverse events, and operator convenience were analyzed.

Results: Data from 53 patients (28 in the OSK group and 25 in the CK group) were analyzed. The mean total injection time was lower in the OSK group than in the CK group (186 s [IQR, 116.8-249.5] vs. 265 s [IQR, 130.5-553.0]), but the difference was not statistically significant (P = 0.082). The total procedure time tended to be shorter in the OSK group than in the CK group (15.5 min [IQR, 11.3-22.8] vs. 20 min [IQR, 13.5-42.5], P = 0.110). Resection rates and adverse events did not differ between the two groups. A greater proportion of endoscopists expressed high satisfaction with the OSK, particularly regarding submucosal injection.

Conclusion: Compared to the CK, OSK use led to shorter injection and procedure times, though not statistically significant. The use of this newly developed endoscopic knife can potentially enhance the effectiveness and efficiency of colorectal ESD (Clinical Research Information Service: KCT0005123).