Usefulness of the clip-and-snare method using the pre-looping technique for endoscopic submucosal dissection of gastric neoplasia: a randomized controlled trial

BACKGROUND: The clip-and-snare method using the pre-looping technique (CSM-PLT) was developed as a traction method for endoscopic submucosal dissection (ESD) of gastric neoplasia. However, its usefulness has not been clearly established; thus, we aimed to assess the efficacy of CSM-PLT in gastric ESD. METHODS: In this multicenter, randomized controlled trial, patients with gastric adenoma or carcinoma with absolute or expanded indications for ESD were randomized into conventional ESD and CSM-PLT groups, using the minimization method based on operator experience, tumor location, tumor size, and excision device. The primary endpoint was ESD procedure time. Secondary endpoints were en bloc and R0 resection rates, and complications. RESULTS: We enrolled 402 patients between July 2017 and February 2020. After excluding patients with deviations from the protocol, we finally analyzed the data of 192 and 186 patients in the conventional and CSM-PLT groups, respectively. The procedure time was significantly shorter in the CSM-PLT group than in the conventional group (58.0 vs. 69.7 min; P=0.009). All lesions were resected en bloc. The R0 resection rate tended to be higher in the CSM-PLT group (P=0.09). No significant differences in complications were observed between the 2 groups. CONCLUSIONS: CSM-PLT is beneficial for gastric ESD when compared with the conventional technique. CSM-PLT significantly reduced procedure times and improved R0 resection rates.