Early phase II study of robot-assisted distal gastrectomy with nodal dissection for clinical stage IA gastric cancer

Abstract

Robot-assisted distal gastrectomy (RADG) is increasingly performed in Japan and Korea and is thought to have many advantages over laparoscopic gastrectomy. However, a prospective study investigating the safety of RADG has never been reported. The present study evaluated the safety of RADG with nodal dissection for clinical stage IA gastric cancer. This single-center, prospective phase II study included patients with clinical stage IA gastric cancer located within the lower two-thirds of the stomach. The primary endpoint was the incidence of postoperative intraabdominal infectious complications including anastomotic leakage, pancreas-related infection, and intraabdominal abscess. The secondary endpoints included all in-hospital adverse events, RADG completion rate, and survival outcome. From May 2012 to November 2012, 18 eligible patients were enrolled for this study. The incidence of intraabdominal infectious complication was 0% (90% CI, 0-12.0%). The overall incidence of in-hospital adverse events was 22.2% (90% CI, 8.0-43.9%). No patient required conversion to laparoscopic or open gastrectomy; thus, the RADG completion rate was 100%. This early phase II study suggested that RADG might be a safe and feasible procedure for stage IA gastric cancer, providing experienced surgeons perform the surgery. This conclusion should be clarified in subsequent late phase II studies with a larger sample size.