title: Non-Randomized Confirmatory Trial of Laparoscopy-Assisted Total Gastrectomy and Proximal Gastrectomy with Nodal Dissection for Clinical Stage I Gastric Cancer: Japan Clinical Oncology Group Study JCOG1401.
abstract: Several prospective studies on laparoscopy-assisted distal gastrectomy for early gastric cancer have been initiated, but no prospective study evaluating laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy has been completed to date. A non-randomized confirmatory trial was commenced in April 2015 to evaluate the safety of laparoscopy-assisted total gastrectomy and laparoscopy-assisted proximal gastrectomy for clinical stage I gastric cancer. A total of 245 patients will be accrued from 42 Japanese institutions over 3 years. The primary endpoint is the proportion of patients with anastomotic leakage. The secondary endpoints are overall survival, relapse-free survival, proportion of patients with completed laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy, proportion of patients with conversion to open surgery, adverse events, and short-term clinical outcomes. The UMIN Clinical Trials Registry number is UMIN000017155.
authors.affiliation: JCOG Data Center/Operations Office, National Cancer Center, Japan.
authors.forename: Kozo
authors.initials: K
authors.lastname: Kataoka
authors.affiliation: Gastric Surgery Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Katai
authors.affiliation: JCOG Data Center/Operations Office, National Cancer Center, Japan.
authors.forename: Junki
authors.initials: J
authors.lastname: Mizusawa
authors.affiliation: JCOG Data Center/Operations Office, National Cancer Center, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Katayama
authors.affiliation: JCOG Data Center/Operations Office, National Cancer Center, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Nakamura
authors.affiliation: Gastric Surgery Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Morita
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
authors.forename: Takaki
authors.initials: T
authors.lastname: Yoshikawa
authors.affiliation: Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Ito
authors.affiliation: Gastric Surgery Division, National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Kinoshita
authors.affiliation: Gastric Surgery Division, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Takeo
authors.initials: T
authors.lastname: Fukagawa
authors.affiliation: Department of Surgery, Hyogo College of Medicine, Hyogo, Japan.
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Sasako
keywords: Gastrectomy; Laparoscopy; Nonrandomized clinical trial