Yoshida M, et al. - This multicenter, randomized controlled trial was performed to elucidate whether dental floss clip traction improved the technical outcomes of endoscopic submucosal dissection (ESD). The physicians suggested that in the overall patient population, dental floss clip traction ESD (DFC-ESD) did not result in shorter procedure time, but it could reduce the risk of perforation. DFC-ESD provided a remarkable reduction in procedure time when selectively applied to lesions located in the greater curvature of the upper or middle stomach.

Methods

• The physicians conducted a superiority, randomized control trial at 14 institutions across Japan.
• They enrolled patients with single gastric neoplasm meeting the indications of the Japanese guidelines for gastric treatment.
• Participants were assigned to receive conventional ESD or dental floss clip traction ESD (DFC-ESD).
• They performed randomization according to a computer-generated random sequence with stratification by institution, tumor location, tumor size, and operator experience.
• ESD procedure time was the primary endpoint, which was defined as the time from the start of the submucosal injection to the end of the tumor removal procedure.

Results

• A total of 640 patients underwent randomization between July 2015 and September 2016.
• Among the randomized patients, the physicians included 316 patients who underwent conventional ESD and 319 patients who underwent DFC-ESD in this analysis.
• For conventional ESD and DFC-ESD, the mean ESD procedure time was 60.7 and 58.1 minutes, respectively (P=0.45).
• In the DFC-ESD group, perforation was less frequent (2.2% vs 0.3%, P=0.04).
• The mean procedure time was significantly shorter in the DFC-ESD group (104.1 vs 57.2 minutes, P=0.01) for lesions located in the greater curvature of the upper or middle stomach.