Hasatani Kenkei, Yoshida Naohiro, Aoyagi Hiroyuki, Utsunomiya Manami, Naito Yoshihide, Matano Yutaka, Tominaga Kei, Waseda Yohei, Doyama Hisashi
Department of Gastroenterology, Fukui Prefectural Hospital, Fukui-shi, Fukui (Kenkei Hasatani, Hiroyuki Aoyagi, Manami Utsunomiya, Yoshihide Naito).
Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa-shi, Ishikawa (Naohiro Yoshida, Manami Utsunomiya, Hisashi Doyama).
Ann Gastroenterol. 2022 Jan-Feb;35(1):48-55. doi: 10.20524/aog.2021.0679. Epub 2021 Dec 6.
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.
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 and R0 resection rates, and complications
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 . 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.
CSM-PLT is beneficial for gastric ESD when compared with the conventional technique. CSM-PLT significantly reduced procedure times and improved R0 resection rates.
采用预圈套技术的套扎-圈套法(CSM-PLT)作为一种牵引方法,用于胃肿瘤的内镜黏膜下剥离术(ESD)。然而,其有效性尚未明确确立;因此,我们旨在评估CSM-PLT在胃ESD中的疗效。
在这项多中心随机对照试验中,根据操作者经验、肿瘤位置、肿瘤大小和切除设备,采用最小化法,将具有ESD绝对或扩大适应证的胃腺瘤或癌患者随机分为传统ESD组和CSM-PLT组。主要终点是ESD手术时间。次要终点是R0切除率和并发症。
2017年7月至2020年2月期间,我们纳入了402例患者。在排除不符合方案的患者后,我们最终分别分析了传统组和CSM-PLT组192例和186例患者的数据。CSM-PLT组的手术时间明显短于传统组(58.0对69.7分钟;P=0.009)。所有病变均被切除。CSM-PLT组的R0切除率有更高的趋势(P=0.09)。两组之间在并发症方面未观察到显著差异。
与传统技术相比,CSM-PLT对胃ESD有益。CSM-PLT显著缩短了手术时间并提高了R0切除率。