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
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.
Dig Dis Sci. 2023 Oct;68(10):3963-3973. doi: 10.1007/s10620-023-08093-y. Epub 2023 Sep 1.
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.
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.
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).
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.
The study was registered at the Japan Registry of Clinical Trial as jRCT1030210015 and jRCT1030210177.
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。
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。
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)。
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。
该研究在日本临床试验注册中心注册为jRCT1030210015和jRCT1030210177。