Standard D2 versus extended D2 (D2+) lymphadenectomy for gastric cancer: an interim safety analysis of a multicenter, randomized, clinical trial

Background A multicenter, randomized, clinical trial was initiated to evaluate the possible benefits of extended D2 (D2+) lymphadenectomy after potentially curative resection of gastric cancer. Methods Standard D2 lymphadenectomy was defined according to the Japanese Gastric Cancer Association classification. D2+ lymph node dissection additionally included the removal of para-aortic nodes. Results Of 781 patients screened, 275 were randomized to standard D2 (n = 141) or extended D2+ (n = 134) lymphadenectomy. The overall morbidity rates were comparable in D2 (27.7%; 95% confidence interval [CI], 20.3–35.1) and D2+ (21.6%; 95% CI, 13.7–29.5) groups (P = .248). Pre-existing cardiac disease, splenectomy, and excessive blood loss were identified as risk factors for overall and nonsurgical complications. Postoperative mortality rates were 4.9% (95% CI, 1.4–8.5) and 2.2% (95% CI, 0–4.7), respectively (P = .376). Conclusions The interim safety analysis failed to show any significant difference with regard to the extent of lymph node dissection. The surgical outcome was not different between the 2 surgeries.