Late phase II study of robot-assisted gastrectomy with nodal dissection for clinical stage I gastric cancer

Abstract

Background: The feasibility of robot-assisted gastrectomy (RG) in terms of safety is unclear due to a lack of prospective studies. We showed feasible surgical outcomes in our previous study. In this phase II study, we assessed feasibility of the procedure by recruiting a larger number of patients.

Method: This single-center, prospective phase II study included patients with clinical stage I gastric cancer undergoing RG. The primary end point was the incidence of postoperative intra-abdominal infectious complications, including anastomotic leakage, pancreas-related infection, and intra-abdominal abscess. The secondary end points were overall survival, relapse-free survival, RG completion rate, and incidence of all surgical morbidities.

Results: A total of 120 patients were recruited between December 2012 and April 2015. The incidence of intra-abdominal infectious complications was 3.3 % (95 % CI 0.9-8.3 %), and all complications were successfully treated conservatively without re-operation. The incidence of overall adverse events was 14.2 % (95 % CI 8.5-21.7 %). Three patients required conversion to open gastrectomy according to the protocol due to advancement of disease.

Conclusion: Our data show that RG is safe in terms of the incidence and severity of postoperative complications.

Keywords: Clinical trial; Gastrectomy; Gastric cancer; Robot; da Vinci.