Multicenter Prospective Randomized Controlled Clinical Trial Comparing the Pocket-Creation Method with and without Single Clip Traction of Colonic Endoscopic Submucosal Dissection.

Background The pocket-creation method (PCM) has been developed to overcome technical difficulties associated with endoscopic submucosal dissection (ESD), nevertheless, opening of the pocket could still be technically challenging. We developed a novel technique named the PCM with single clip traction (PCM-CT), which utilizes a general-purpose reopenable clip as a traction device to maintain stability during the procedure. To date, no prospective study has compared the efficacy between PCM-CT and the PCM. The aim of this study is to investigate the effectiveness of PCM-CT compared to the PCM in a randomized controlled trial. Methods This randomized controlled clinical trial was conducted at four Japanese institutions. Patients with superficial colorectal neoplastic lesions were included following Japanese guidelines for colorectal cancer. Seven moderately experienced endoscopists performed the ESD procedures using either PCM-CT or PCM. Results A total of 100 patients were enrolled in this study. PCM-CT procedure achieved significant faster dissection speed and reduced the procedure time and pocket-opening time compared to the PCM (27.0±14.5 vs 21.4±10.8 mm2/min, 95% confidence interval (CI) [0.5, 10.7], p=0.031, 64.8±47.6 vs 81.8±57.9 min, 95% CI [-38.2, 4.3], p=0.116, 30.0±28.9 vs 37.8±33.0 min, 95% CI [-20.2, 4.6], p=0.217). En-bloc resection and R0 resection rates were not significantly different between the two groups (100% vs 100%, p=1.000, 100% vs 96%, p=0.495). No significant differences were observed in adverse events between the two groups. Conclusion ESD facilitated by the novel PCM-CT appears to be significantly faster. Additionally, both PCM-CT and PCM achieved high R0 resection rate.