Phase II study of laparoscopy-assisted distal gastrectomy with nodal dissection for clinical stage I gastric cancer: Japan Clinical Oncology Group Study JCOG0703.
A phase II trial was started in Japan to evaluate the safety of laparoscopy-assisted distal gastrectomy (LADG) for clinical stage I gastric cancer. A total of 170 patients will be enrolled in this study by expert surgeons for laparoscopy from 16 institutions over 1 year. The primary endpoint is incidence of anastomotic leak and pancreatic fistula. The secondary endpoints are overall survival, relapse-free survival, proportion of completion of LADG, proportion of conversion from LADG to open gastrectomy, surgical morbidity and short-term clinical outcomes.
Kurokawa
Yukinori
Y
Gastric Surgery Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
Katai
Hitoshi
H
Fukuda
Haruhiko
H
Sasako
Mitsuru
M
D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D005743:Gastrectomy / Q000379:methods*; D006801:Humans; D007564:Japan; D010535:Laparoscopy; D008197:Lymph Node Excision / Q000379:methods*; D008875:Middle Aged; D009367:Neoplasm Staging; D018579:Patient Selection; D012107:Research Design; D012449:Safety; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*