Current status of a randomized controlled trial examining laparoscopic gastrectomy for gastric cancer in Japan.

More than 20 years after the introduction of laparoscopic gastrectomy, two ongoing, large-scale randomized controlled trials are currently being conducted in Japan: JCOG0912 for patients with stage I disease and JLSSG0901 for patients with advanced cancer. Both trials are designed to evaluate the non-inferiority of laparoscopic-assisted distal gastrectomy to its open counterpart. The primary end-point of JCOG0912 is overall survival, whereas that of JLSSG0901 is relapse-free survival. Quality control for the surgeries is being strictly performed in each study; eligibility criteria apply to participating surgeons and a central review of the surgical procedure has been conducted. The accrual of patients for JCOG0912 and for JLSSG0901 (phase II) is complete, and the disclosure of level I evidence is being awaited.