Author:
Makuuchi Rie,Terashima Masanori,Terada Mitsumi,Mizusawa Junki,Kita Ryosuke,Tokunaga Masanori,Omori Takeshi,Ojima Toshiyasu,Ehara Kazuhisa,Watanabe Masaya,Yanagimoto Yoshitomo,Nunobe Souya,Kinoshita Takahiro,Ito Seiji,Nishida Yasunori,Hihara Jun,Boku Narikazu,Kurokawa Yukinori,Yoshikawa Takaki,
Abstract
Abstract
Background
Laparoscopic gastrectomy (LG) is considered a standard treatment for clinical stage I gastric cancer. Nevertheless, LG has some drawbacks, such as motion restriction and difficulties in spatial perception. Robot-assisted gastrectomy (RG) overcomes these drawbacks by using articulated forceps, tremor-filtering capability, and high-resolution three-dimensional imaging, and it is expected to enable more precise and safer procedures than LG for gastric cancer. However, robust evidence based on a large-scale randomized study is lacking.
Methods
We are performing a randomized controlled phase III study to investigate the superiority of RG over LG for clinical T1-2N0-2 gastric cancer in terms of safety. In total, 1,040 patients are planned to be enrolled from 46 Japanese institutions over 5 years. The primary endpoint is the incidence of postoperative intra-abdominal infectious complications, including anastomotic leakage, pancreatic fistula, and intra-abdominal abscess of Clavien–Dindo (CD) grade ≥ II. The secondary endpoints are the incidence of all CD grade ≥ II and ≥ IIIA postoperative complications, the incidence of CD grade ≥ IIIA postoperative intra-abdominal infectious complications, relapse-free survival, overall survival, the proportion of RG completion, the proportion of LG completion, the proportion of conversion to open surgery, the proportion of operation-related death, and short-term surgical outcomes. The Japan Clinical Oncology Group Protocol Review Committee approved this study protocol in January 2020. Approval from the institutional review board was obtained before starting patient enrollment in each institution. Patient enrollment began in March 2020. We revised the protocol to expand the eligibility criteria to T1-4aN0-3 in July 2022 based on the results of randomized trials of LG demonstrating non-inferiority of LG to open surgery for survival outcomes in advanced gastric cancer.
Discussion
This is the first multicenter randomized controlled trial to confirm the superiority of RG over LG in terms of safety. This study will demonstrate whether RG is superior for gastric cancer.
Trial registration
The protocol of JCOG1907 was registered in the UMIN Clinical Trials Registry as UMIN000039825 (http://www.umin.ac.jp/ctr/index.htm). Date of Registration: March 16, 2020. Date of First Participant Enrollment: April 1, 2020.
Funder
National Cancer Center Research and Development Fund
Japan Agency for Medical Research and Development
Intuitive Surgical Sàrl
Publisher
Springer Science and Business Media LLC
Subject
Cancer Research,Genetics,Oncology
Cited by
8 articles.
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