Conventional versus traction-assisted endoscopic submucosal dissection for gastric neoplasms: a multicenter, randomized controlled trial (with video),Gastrointestinal Endoscopy

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Conventional versus traction-assisted endoscopic submucosal dissection for gastric neoplasms: a multicenter, randomized controlled trial (with video)
Gastrointestinal Endoscopy ( IF 7.7 ) Pub Date : 2017-12-09 , DOI: 10.1016/j.gie.2017.11.031
Masao Yoshida , Kohei Takizawa , Sho Suzuki , Yoshiki Koike , Satoru Nonaka , Yasushi Yamasaki , Takeyoshi Minagawa , Chiko Sato , Chihiro Takeuchi , Ko Watanabe , Hiromitsu Kanzaki , Hiroyuki Morimoto , Takafumi Yano , Kosuke Sudo , Keita Mori , Takuji Gotoda , Hiroyuki Ono , Masao Yoshida , Kohei Takizawa , Keita Mori , Hiroyuki Ono , Yoshiki Koike , Dai Hirasawa , Satoru Nonaka , Ichiro Oda , Yasushi Yamasaki , Noriya Uedo , Takeyoshi Minagawa , Ryoji Fujii , Tetsuya Sumiyoshi , Chiko Sato , Kingo Hirasawa , Chihiro Takeuchi , Yosuke Tsuji , Ko Watanabe , Takuto Hikichi , Takuji Gotoda , Hiromitsu Kanzaki , Kou Miura , Hiroyuki Okada , Hiroyuki Morimoto , Hiroshi Nakamura , Tomonori Yano , Sho Suzuki , Chika Kusano , Takafumi Yano , Satoshi Tanabe , Kosuke Sudo , Yumi Mashimo , Keiko Minashi , Takako Nakajima , Yukinori Kurokawa

Background and Aims

The aim of this study was to clarify whether dental floss clip (DFC) traction improves the technical outcomes of endoscopic submucosal dissection (ESD).

Methods

A superiority, randomized control trial was conducted at 14 institutions across Japan. Patients with single gastric neoplasm meeting the indications of the Japanese guidelines for gastric treatment were enrolled and assigned to receive conventional ESD or DFC traction-assisted ESD (DFC-ESD). Randomization was performed according to a computer-generated random sequence with stratification by institution, tumor location, tumor size, and operator experience. The primary endpoint was ESD procedure time, defined as the time from the start of the submucosal injection to the end of the tumor removal procedure.

Results

Between July 2015 and September 2016, 640 patients underwent randomization. Of these, 316 patients who underwent conventional ESD and 319 patients who underwent DFC-ESD were included in our analysis. The mean ESD procedure time was 60.7 and 58.1 minutes for conventional ESD and DFC-ESD, respectively (P = .45). Perforation was less frequent in the DFC-ESD group (2.2% vs .3%, P = .04). For lesions located in the greater curvature of the upper or middle stomach, the mean procedure time was significantly shorter in the DFC-ESD group (104.1 vs 57.2 minutes, P = .01).

Conclusions

Our findings suggest that DFC-ESD does not result in shorter procedure time in the overall patient population, but it can reduce the risk of perforation. When selectively applied to lesions located in the greater curvature of the upper or middle stomach, DFC-ESD provides a remarkable reduction in procedure time.

中文翻译：

常规与牵引辅助内镜下胃黏膜下剥离术治疗胃肿瘤的多中心随机对照试验（附视频）

背景和目标

这项研究的目的是阐明牙线夹（DFC）牵引是否可以改善内窥镜黏膜下剥离术（ESD）的技术效果。

方法

在日本的14家机构中进行了一项优越性随机对照试验。符合日本胃部治疗指征的单胃肿瘤患者入组并接受常规ESD或DFC牵引辅助ESD（DFC-ESD）。根据计算机生成的随机序列进行随机分组，并按机构，肿瘤位置，肿瘤大小和操作者经验进行分层。主要终点为ESD手术时间，定义为从粘膜下注射开始到肿瘤切除手术结束的时间。

结果

在2015年7月至2016年9月之间，共有640名患者接受了随机分组。在我们的分析中，包括316例接受常规ESD的患者和319例接受DFC-ESD的患者。传统ESD和DFC-ESD的平均ESD程序时间分别为60.7分钟和58.1分钟（P = .45）。DFC-ESD组的穿孔频率较低（2.2％vs.3％，P = .04）。对于位于上腹部或中腹部较大弯曲处的病变，DFC-ESD组的平均手术时间明显缩短（104.1 vs 57.2分钟，P = 0.01）。