Background and Aims

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).

Methods

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.

Results

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.

Conclusions

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.)

中文翻译：

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一项前瞻性随机试验比较了袋内创口法和常规结直肠内镜黏膜下剥离术的方法。

背景和目标

大肠内镜黏膜下剥离术（ESD）被认为是一项具有挑战性的手术。以前，我们报道了一种采用袋式创建方法（PCM）的新ESD策略可用于结直肠ESD，但尚无前瞻性随机研究评估PCM的疗效。这项研究的目的是评估与传统方法（CM）相比，PCM对结直肠ESD的功效和安全性。

方法

这是在日本3家机构进行的前瞻性随机对照试验。预计浅表性结直肠肿瘤性病变> 20 mm预计为粘膜内的患者被随机分配接受PCM或CM的ESD治疗。主要结果是ESD完成率，定义为使用指定的ESD方法使用整块切除术完成结直肠ESD的完成，而无需更改为其他方法或由其他设备辅助。

结果

我们分析了PCM组59例患者和59例大肠肿瘤，而CM组55例。PCM组的ESD完成率明显高于CM组（93％[55/59]对73％[40/55]；P = .01）。两组的整体切除率，R0切除率，手术时间和解剖速度无显着差异。两组的不良事件发生率相似。

结论

与具有相似临床结果的CM相比，使用PCM可使内镜医师更频繁地使用预期方法完成手术。（临床试验注册号：UMIN000024394。）