Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan; Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan.
Department of Coloproctology, Fukushima Medical University, Aizu Medical Center, Aizuwakamatsu, Japan.
Gastrointest Endosc. 2020 Aug;92(2):368-379. doi: 10.1016/j.gie.2020.02.034. Epub 2020 Feb 29.
Colorectal endoscopic submucosal dissection (ESD) is recognized as a challenging procedure. Previously, we reported that a new ESD strategy using the pocket-creation method (PCM) is useful for colorectal ESD, but no prospective randomized study has evaluated the efficacy of the PCM. The aim of this study was to evaluate the efficacy and safety of PCM for colorectal ESD compared with the conventional method (CM).
This was a prospective randomized controlled trial at 3 institutions in Japan. Patients with superficial colorectal neoplastic lesions >20 mm predicted to be intramucosal were randomly assigned to undergo ESD using the PCM or CM. Primary outcome was the ESD completion rate defined as completion of colorectal ESD with an en bloc resection using the assigned ESD method without changing to other methods or assisted by other devices.
We analyzed 59 patients with 59 colorectal tumors in the PCM group and 55 in the CM group. The ESD completion rate was significantly higher in the PCM group compared with the CM group (93% [55/59] vs 73% [40/55]; P = .01). En bloc resection rates, R0 resection rates, procedure time, and dissection speed were not significantly different between the 2 groups. The incidence of adverse events was similar in the 2 groups.
Use of the PCM allows the endoscopist to complete the procedure with the intended method more often than the CM with similar clinical outcomes. (Clinical trial registration number: UMIN 000024394.).
结直肠内镜黏膜下剥离术（ESD）被认为是一项具有挑战性的操作。我们先前报道了一种使用口袋创建法（PCM）的新 ESD 策略，该策略对结直肠 ESD 有用，但尚无前瞻性随机研究评估 PCM 的疗效。本研究旨在评估 PCM 与传统方法（CM）相比在结直肠 ESD 中的疗效和安全性。
这是在日本的 3 家机构进行的一项前瞻性随机对照试验。将预计为黏膜内的>20mm 的浅层结直肠肿瘤患者随机分配接受 PCM 或 CM 进行 ESD。主要结局是 ESD 完成率，定义为使用分配的 ESD 方法整块切除结直肠 ESD，而无需更改为其他方法或辅助其他设备。
我们分析了 PCM 组的 59 例 59 个结直肠肿瘤患者和 CM 组的 55 例患者。PCM 组的 ESD 完成率明显高于 CM 组（93%[55/59]比 73%[40/55]；P=0.01）。整块切除率、R0 切除率、手术时间和剥离速度在两组之间无显著差异。两组不良事件的发生率相似。
与 CM 相比，PCM 的使用使内镜医生更频繁地使用预期方法完成手术，而临床结局相似。（临床试验注册号：UMIN 000024394.）。
