Abstract
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.
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