Randomized controlled phase III trial to investigate superiority of robot-assisted gastrectomy over laparoscopic gastrectomy for clinical stage T1-4aN0-3 gastric cancer patients (JCOG1907, MONA LISA study): a study protocol

BMC Cancer

Study Protocol

Takahiro Kinoshita¹  Takaki Yoshikawa²  Seiji Ito³  Rie Makuuchi⁴  Souya Nunobe⁴  Takeshi Omori⁵  Yukinori Kurokawa⁶  Kazuhisa Ehara⁷  Masaya Watanabe⁸  Masanori Tokunaga⁹  Mitsumi Terada^1,10  Narikazu Boku^1,11  Jun Hihara^1,12  Yasunori Nishida^1,13  Yoshitomo Yanagimoto^1,14  Masanori Terashima^1,15  Ryosuke Kita^1,16  Junki Mizusawa^1,16  Toshiyasu Ojima^1,17 

[1] Department of Gastric Surgery, National Cancer Center Hospital East, Kashiwa, Japan;Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan;Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan;Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, 135-8550, Tokyo, Japan;Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan;Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan;Department of Gastroenterological Surgery, Saitama Cancer Center, Saitama, Japan;Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan;Department of Gastrointestinal Surgery, Tokyo Medical and Dental University, Tokyo, Japan;Department of International Clinical Development, National Cancer Center Hospital, Tokyo, Japan;Department of Oncology and General Medicine, IMSUT Hospital, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan;Department of Surgery, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima, Japan;Department of Surgery, Keiyukai Sapporo Hospital, Hokkaido, Japan;Department of Surgery, Toyonaka Municipal Hospital, Osaka, Japan;Division of Gastric Surgery, Shizuoka Cancer Center, 1007, Shimonagakubo, Nagaizumi-Cho, Sunto-Gun, Shizuoka, Japan;Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan;Second Department of Surgery, Wakayama Medical University Scholl of Medicine, Wakayama, Japan;

关键词: Stomach neoplasms;    Robotic surgery;    Minimally invasive surgery;    Postoperative complication;    Multicenter study;    Randomized controlled trial;   

DOI  :  10.1186/s12885-023-11481-2

 received in 2023-08-25, accepted in 2023-10-05,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundLaparoscopic 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.MethodsWe 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.DiscussionThis 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 registrationThe 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.

【 授权许可】

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