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.

Journal: BMC cancer
PMID:

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.

Authors

  • Rie Makuuchi
    Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
  • Masanori Terashima
    Division of Gastric Surgery, Shizuoka Cancer Center, Nagaizumi, Shizuoka 411-8777, Japan. Electronic address: m.terashima@scchr.jp.
  • Mitsumi Terada
    Department of International Clinical Development, National Cancer Center Hospital, Tokyo, Japan.
  • Junki Mizusawa
    Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
  • Ryosuke Kita
    Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
  • Masanori Tokunaga
    Department of Gastrointestinal surgery, Tokyo Medical and Dental University, Tokyo, Japan.
  • Takeshi Omori
    Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
  • Toshiyasu Ojima
    Second Department of Surgery, Wakayama Medical University Scholl of Medicine, Wakayama, Japan.
  • Kazuhisa Ehara
    Department of Gastroenterological Surgery, Saitama Cancer Center, Saitama, Japan.
  • Masaya Watanabe
    Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan.
  • Yoshitomo Yanagimoto
    Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Japan.
  • Souya Nunobe
    Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan.
  • Takahiro Kinoshita
    Department of Gastric Surgery, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
  • Seiji Ito
    Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
  • Yasunori Nishida
    Department of Surgery, Keiyukai Sapporo Hospital, Hokkaido, Japan.
  • Jun Hihara
    Department of Surgery, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima, Japan.
  • Narikazu Boku
    Department of Oncology and General Medicine, IMSUT Hospital, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.
  • Yukinori Kurokawa
    Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
  • Takaki Yoshikawa