Conventional versus traction-assisted endoscopic submucosal dissection for large esophageal cancers: a multicenter, randomized controlled trial (with video)

• Published in: Gastrointestinal endoscopy 2020-01, Vol.91 (1), p.55-65.e2
• Main Authors: Yoshida, Masao, Takizawa, Kohei, Nonaka, Satoru, Shichijo, Satoki, Suzuki, Sho, Sato, Chiko, Komori, Hiroyuki, Minagawa, Takeyoshi, Oda, Ichiro, Uedo, Noriya, Hirasawa, Kingo, Matsumoto, Kenshi, Sumiyoshi, Tetsuya, Mori, Keita, Gotoda, Takuji, Ono, Hiroyuki, Kusano, Chika, Takeda, Tsutomu, Fujii, Ryoji, Yamasaki, Yasushi, Minashi, Keiko, Nakajima, Takako, Kurokawa, Yukinori
• Format: Article
• Language: English
• ISSN: 0016-5107; 1097-6779
• DOI: 10.1016/j.gie.2019.08.014

Endoscopic submucosal dissection (ESD) is widely used as a minimally invasive treatment for large esophageal cancers, but prolonged procedure duration and life-threatening adverse events remain matters of concern. We aimed to determine whether traction-assisted ESD (TA-ESD) is superior to conventional ESD in terms of technical outcomes. A superiority, randomized, phase III trial was conducted at 7 institutions across Japan. Patients with large esophageal cancer (defined as tumor diameter >20 mm) were eligible for this study. Enrolled patients were randomly assigned to undergo conventional ESD or TA-ESD. The primary endpoint was ESD procedure duration. Two hundred forty-one patients were recruited and randomized. On applying exclusion criteria, 117 and 116 patients who underwent conventional ESD and TA-ESD, respectively, were included in the baseline analysis. In 1 patient, conventional ESD was discontinued because of severe perforation. Thus, the final analysis included 116 patients per group (primary analysis). The ESD procedure duration was significantly shorter for TA-ESD than for conventional ESD (44.5 minutes vs 60.5 minutes, respectively; P < .001). Moreover, no adverse events were noted in the TA-ESD group. The rate of horizontal margin involvement did not differ between the groups (10.3% vs 6.9% for conventional ESD and TA-ESD, respectively; P = .484). TA-ESD was superior to conventional ESD in terms of procedure duration and was not associated with any adverse events. TA-ESD should be considered the procedure of choice for large esophageal cancers. (Clinical trial registration number: UMIN000024080.)