Journal of Gastric Cancer

The Korean Gastric Cancer Association (대한위암학회)
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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)
  • Received : 2016.03.29
  • Accepted : 2016.05.07
  • Published : 2016.06.30
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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

References

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