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.
- Author:
Kozo KATAOKA
1
;
Hitoshi KATAI
;
Junki MIZUSAWA
;
Hiroshi KATAYAMA
;
Kenichi NAKAMURA
;
Shinji MORITA
;
Takaki YOSHIKAWA
;
Seiji ITO
;
Takahiro KINOSHITA
;
Takeo FUKAGAWA
;
Mitsuru SASAKO
Author Information
- Publication Type:Original Article
- Keywords: Laparoscopy; Gastrectomy; Nonrandomized clinical trial
- MeSH: Anastomotic Leak; Asian Continental Ancestry Group; Conversion to Open Surgery; Gastrectomy*; Humans; Japan*; Laparoscopy; Medical Oncology*; Non-Randomized Controlled Trials as Topic; Prospective Studies; Stomach Neoplasms*
- From:Journal of Gastric Cancer 2016;16(2):93-97
- CountryRepublic of Korea
- Language:English
- 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.
