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Kozo Kataoka,Hitoshi Katai,Junki Mizusawa,Hiroshi Katayama,Kenichi Nakamura,Shinji Morita,Takaki Yoshikawa,Seiji Ito,Takahiro Kinoshita,Takeo Fukagawa,Mitsuru Sasako,Stomach Cancer Study Group/Japan C 대한위암학회 2016 Journal of gastric cancer Vol.16 No.2
Several prospective studies on laparoscopy-assisted distal gastrectomy for early gastric cancer have been initiated, but no prospectivestudy evaluating laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy has been completed to date. Anon-randomized confirmatory trial was commenced in April 2015 to evaluate the safety of laparoscopy-assisted total gastrectomy andlaparoscopy-assisted proximal gastrectomy for clinical stage I gastric cancer. A total of 245 patients will be accrued from 42 Japaneseinstitutions over 3 years. The primary endpoint is the proportion of patients with anastomotic leakage. The secondary endpoints areoverall survival, relapse-free survival, proportion of patients with completed laparoscopy-assisted total gastrectomy or laparoscopy-assistedproximal gastrectomy, proportion of patients with conversion to open surgery, adverse events, and short-term clinical outcomes. TheUMIN Clinical Trials Registry number is UMIN000017155.
Kataoka, Kozo,Katai, Hitoshi,Mizusawa, Junki,Katayama, Hiroshi,Nakamura, Kenichi,Morita, Shinji,Yoshikawa, Takaki,Ito, Seiji,Kinoshita, Takahiro,Fukagawa, Takeo,Sasako, Mitsuru The Korean Gastric Cancer Association 2016 Journal of gastric cancer Vol.16 No.2
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.