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http://dx.doi.org/10.5230/jgc.2016.16.2.93

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  

Kataoka, Kozo (JCOG Data Center/Operations Office, National Cancer Center)
Katai, Hitoshi (Gastric Surgery Division, National Cancer Center Hospital)
Mizusawa, Junki (JCOG Data Center/Operations Office, National Cancer Center)
Katayama, Hiroshi (JCOG Data Center/Operations Office, National Cancer Center)
Nakamura, Kenichi (JCOG Data Center/Operations Office, National Cancer Center)
Morita, Shinji (Gastric Surgery Division, National Cancer Center Hospital)
Yoshikawa, Takaki (Department of Gastrointestinal Surgery, Kanagawa Cancer Center)
Ito, Seiji (Department of Gastroenterological Surgery, Aichi Cancer Center Hospital)
Kinoshita, Takahiro (Gastric Surgery Division, National Cancer Center Hospital East)
Fukagawa, Takeo (Gastric Surgery Division, National Cancer Center Hospital)
Sasako, Mitsuru (Department of Surgery, Hyogo College of Medicine)
Publication Information
Journal of Gastric Cancer / v.16, no.2, 2016 , pp. 93-97 More about this Journal
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.
Keywords
Laparoscopy; Gastrectomy; Nonrandomized clinical trial;
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