Phase II study of laparoscopy-assisted distal gastrectomy with nodal dissection for clinical stage I gastric cancer: Japan Clinical Oncology Group Study JCOG0703.

摘要

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.