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早期胃癌中传统内镜黏膜下剥离术与水刀辅助内镜黏膜下剥离术的比较:一项随机对照试验

Conventional vs. waterjet-assisted endoscopic submucosal dissection in early gastric cancer: a randomized controlled trial.

作者信息

Zhou Ping-Hong, Schumacher Brigitte, Yao Li-Qing, Xu Mei-Dong, Nordmann Thomas, Cai Ming-Yan, Charton Jean-Pierre, Vieth Michael, Neuhaus Horst

机构信息

Endoscopy Center, Zhongshan Hospital, Fudan University, Shanghai, China.

Department of Internal Medicine, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany.

出版信息

Endoscopy. 2014 Oct;46(10):836-43. doi: 10.1055/s-0034-1377580. Epub 2014 Sep 17.

Abstract

BACKGROUND AND STUDY AIMS

A hybrid knife was recently developed to allow waterjet-assisted endoscopic submucosal dissection, which aims to speed up and simplify the procedure. This technique has been shown to be effective and safe for the treatment of early gastric cancer (EGC) but it has not yet been compared with conventional ESD.

PATIENTS AND METHODS

In this two-center study, patients with an endoscopic and histopathological diagnosis of gastric adenoma or early gastric adenocarcinoma (meeting the extended Japanese criteria for local resection) were randomized to either conventional or waterjet-assisted ESD. The choice of knife was left to the endoscopist in the conventional group whereas the hybrid knife was used in the waterjet group. The primary end point was procedure time, and secondary outcomes included rates of en bloc resection, R0 resection, and complications.

RESULTS

A total of 117 patients (mean age 63.0 ± 10.6 years, 76 men) were randomized to either conventional ESD (n  = 59; control group) or waterjet-assisted ESD (n = 58). There were no significant differences in patient demographics or lesion features between the groups. The mean procedure time was significantly shorter in the waterjet group compared with the conventional group (27.5  ±  30.6 vs. 35.0  ± 22.5 minutes; P = 0.0008), and a change of accessories was less frequently required (mean number of changes 1.4  ±  2.0 vs. 23.0  ±  15.4; P < 0.0001). There was no significant difference between the groups in the size of resected specimen, R0 resection rates, number of perforations, major delayed bleedings, or rates of complete remission of neoplasia after 3 months.

CONCLUSIONS

Waterjet-assisted ESD and conventional ESD are comparably effective and safe techniques for the local treatment of EGC. The waterjet-assisted technique is a faster and simpler procedure and requires fewer accessory changes compared with conventional ESD.

摘要

背景与研究目的

最近研发了一种混合刀,用于水刀辅助内镜黏膜下剥离术,旨在加快并简化该手术过程。该技术已被证明在治疗早期胃癌(EGC)方面有效且安全,但尚未与传统内镜黏膜下剥离术(ESD)进行比较。

患者与方法

在这项双中心研究中,经内镜及组织病理学诊断为胃腺瘤或早期胃腺癌(符合日本扩大的局部切除标准)的患者被随机分为传统ESD组或水刀辅助ESD组。传统组由内镜医师自行选择刀具,而水刀组使用混合刀。主要终点为手术时间,次要结局包括整块切除率、R0切除率及并发症发生率。

结果

共有117例患者(平均年龄63.0±10.6岁,男性76例)被随机分为传统ESD组(n = 59;对照组)或水刀辅助ESD组(n = 58)。两组患者的人口统计学特征或病变特征无显著差异。与传统组相比,水刀组的平均手术时间显著缩短(27.5±30.6 vs. 35.0±22.5分钟;P = 0.0008),且更换附件的频率更低(平均更换次数1.4±2.0 vs. 23.0±15.4;P < 0.0001)。两组在切除标本大小、R0切除率、穿孔数量、严重迟发性出血或3个月后肿瘤完全缓解率方面无显著差异。

结论

水刀辅助ESD和传统ESD在EGC局部治疗中同样有效且安全。与传统ESD相比,水刀辅助技术手术速度更快、更简单,且更换附件的次数更少。

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