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21 - 30毫米结直肠息肉的水下内镜黏膜切除术和内镜黏膜下剥离术的结果:一项可行性研究

Outcomes for Underwater Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection of 21-30-mm Colorectal Polyps: A Feasible Study.

作者信息

Okimoto Kenichiro, Matsumura Tomoaki, Matsusaka Keisuke, Inaba Yosuke, Ishikawa Tsubasa, Akizue Naoki, Kaneko Tatsuya, Ota Masayuki, Ohta Yuki, Taida Takashi, Saito Keiko, Ogasawara Sadahisa, Maruoka Daisuke, Kato Jun, Ikeda Jun-Ichiro, Kato Naoya

机构信息

Department of Gastroenterology, Graduate School of Medicine, Chiba University, Inohana 1-8-1, Chiba, 260-8670, Japan.

Department of Pathology, Chiba University Hospital, Chiba, Japan.

出版信息

Dig Dis Sci. 2023 Oct;68(10):3963-3973. doi: 10.1007/s10620-023-08093-y. Epub 2023 Sep 1.

Abstract

BACKGROUND AND AIMS

This randomized controlled trial (RCT) was designed to evaluate the short-term outcomes of underwater endoscopic mucosal resection (UEMR) and endoscopic submucosal dissection (ESD) of 21-30 mm colonic polyps.

METHOD

We conducted a single-center RCT. Patients diagnosed with suspected colorectal intramucosal carcinoma (21-30 mm and adaptable for both UEMR and ESD) were randomly assigned to the UEMR and ESD groups at a 1:1 ratio. The primary endpoint was the R0 resection rate. We independently performed one-sample tests against the set threshold for each treatment. The significance level was set at p = 0.224.

RESULT

Eleven polyps each in the UEMR and ESD groups, respectively, were analyzed. The R0 resection rate (%) was 36 (95% confidence interval 11-69) and 100 (72-100) for UEMR and ESD, respectively, with a significant difference between the two groups (p = 0.002). The p-value against the set threshold for UEMR was 0.743, whereas that for ESD was < 0.001 (one-sample binomial test). The en bloc resection rates (%) were 82 (48-97) and 100 (72-100) for UEMR and ESD, respectively; however, no significant difference was observed (p = 0.167). The mean treatment time (min) was significantly shorter in the UEMR group (8 ± 6) than in the ESD group (48 ± 29) (p = 0.001).

CONCLUSION

ESD could achieve a high R0 resection rate, while the en bloc resection rate was comparable between the two treatment techniques with less burden on patients undergoing UEMR for 21-30-mm colorectal polyps.

CLINICAL TRIAL REGISTRATION

The study was registered at the Japan Registry of Clinical Trial as jRCT1030210015 and jRCT1030210177.

摘要

背景与目的

本随机对照试验(RCT)旨在评估21 - 30毫米结肠息肉的水下内镜黏膜切除术(UEMR)和内镜黏膜下剥离术(ESD)的短期疗效。

方法

我们开展了一项单中心RCT。将诊断为疑似结直肠黏膜内癌(21 - 30毫米且适用于UEMR和ESD)的患者按1:1比例随机分配至UEMR组和ESD组。主要终点是R0切除率。我们针对每种治疗方法独立进行了与设定阈值的单样本检验。显著性水平设定为p = 0.224。

结果

分别对UEMR组和ESD组的11枚息肉进行了分析。UEMR组和ESD组的R0切除率(%)分别为36(95%置信区间11 - 69)和100(72 - 100),两组间差异有统计学意义(p = 0.002)。UEMR组与设定阈值相比的p值为0.743,而ESD组的p值<0.001(单样本二项式检验)。UEMR组和ESD组的整块切除率(%)分别为82(48 - 97)和100(72 - 100);然而,未观察到显著差异(p = 0.167)。UEMR组的平均治疗时间(分钟)(8 ± 6)显著短于ESD组(48 ± 29)(p = 0.001)。

结论

对于21 - 30毫米的结直肠息肉,ESD可实现较高的R0切除率,而两种治疗技术的整块切除率相当,UEMR对患者的负担较小。

临床试验注册

该研究在日本临床试验注册中心注册为jRCT1030210015和jRCT1030210177。

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