Masao Yoshida1, Kohei Takizawa1, Satoru Nonaka2, Satoki Shichijo3, Sho Suzuki4, Chiko Sato5, Hiroyuki Komori6, Takeyoshi Minagawa7, Ichiro Oda2, Noriya Uedo3, Kingo Hirasawa5, Kenshi Matsumoto6, Tetsuya Sumiyoshi7, Keita Mori8, Takuji Gotoda4, Hiroyuki Ono1. 1. Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan. 2. Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan. 3. Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan. 4. Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan. 5. Division of Endoscopy, Yokohama City University Medical Center, Kanagawa, Japan. 6. Department of Gastroenterology, Juntendo University, Tokyo, Japan. 7. Department of Gastroenterology, Tonan Hospital, Hokkaido, Japan. 8. Clinical Trial Coordination Office, Shizuoka Cancer Center, Shizuoka, Japan.
Abstract
BACKGROUND AND AIMS: 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. METHODS: 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. RESULTS: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). CONCLUSIONS: 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.).
RCT Entities:
BACKGROUND AND AIMS: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.).