Feasibility of Laparoscopic Radical Gastrectomy for Gastric Cancer of Clinical Stage II or Higher: Early Outcomes in a Phase II Study (KUGC04).

Abstract

A phase II study was performed to evaluate the safety and efficacy of laparoscopic gastrectomy (LG) for gastric cancer of clinical stage II or higher. The eligibility criteria were gastric cancer of clinical stage II or higher that was amenable to potentially curative resection. Patients with prior chemotherapy, tumors requiring total gastrectomy (TG), tumors that invaded adjacent organs, and patients with bulky lymph node metastasis were included. The primary endpoint was incidence of postoperative complications of grade II or higher in the Clavien-Dindo classification. The sample size was determined to be 73, based on an expected rate of complications of 19 % and a threshold of 30 %. Gastrectomy was performed by expert surgeons who were certified by the Japan Society for Endoscopic Surgery. A total of 73 patients were enrolled; 54 patients (74 %) had clinical T stage T4a/T4b, and 47 patients (64 %) were administered preoperative chemotherapy. The type of surgery was distal gastrectomy in 41 patients and TG in 31 patients. Dissection of D2 or more was performed in 62 patients (85 %). Of the 25 patients who underwent D2/D2+ TG, 15 underwent splenectomy or pancreaticosplenectomy. R0 resection was performed in 64 patients (88 %). The median number of resected lymph nodes was 56, and postoperative complications occurred in 15 patients (20.5 %), which was significantly lower than the threshold value (p = 0.039). One in-hospital death occurred (1.4 %). LG for gastric cancer of clinical stage II or higher can be safely performed by experienced surgeons.