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
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(Kozo Kataoka) - National Cancer Center JCOG Data Center/Operations Office
(Hitoshi Kata) - National Cancer Center Hospital Division Gastric Surgery
(Junki Mizusawa) - National Cancer Center JCOG Data Center/Operations Office
(Hiroshi Katayama) - National Cancer Center JCOG Data Center/Operations Office
(Kenichi Nakamura) - National Cancer Center JCOG Data Center/Operations Office
(Shinji Morita) - National Cancer Center Hospital Division Gastric Surgery
(Takaki Yoshikawa) - Kanagawa Cancer Center Department of Gastrointestinal Surgery
(Seiji Ito) - Aichi Cancer Center Hospital Department of Gastroenterological Surgery
(Takahiro Kinoshita) - National Cancer Center Hospital Division Gastric Surgery
(Takeo Fukagawa) - National Cancer Center Hospital Division Gastric Surgery
(Mitsuru Sasako) - Hyogo College of Medicine Department of Surgery
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-assist-ed 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.
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Laparoscopy, Gastrectomy, Nonrandomized clinical trial
KMID :
0914820160160020093
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The results of the study protocol will be overall survival, relapse-free survival, proportion of patients with completed laparoscopy-assisted total gastrectomy or laparoscopy-assist-ed proximal gastrectomy, proportion of patients with conversion to open surgery, adverse events, and short-term clinical outcomes.