A phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer (JCOG0912): Analysis of the safety and short-term clinical outcomes.

4017 Background: Although the number of patients undergoing laparoscopy-assisted distal gastrectomy (LADG) has been increasing, there is no confirmatory randomized controlled trial (RCT) to evaluate the efficacy of LADG compared with open distal gastrectomy (ODG). Safety and short term outcome are presented. Methods: We conducted a RCT to confirm the non-inferiority of overall survival (OS) of LADG to ODG in patients with clinical IA (T1N0) or IB (T1N1 or T2 [MP] N0) gastric cancer. D1 or more dissection is applied for clinical stage IA and D2 dissection for clinical stage IB. Only the credentialed surgeons can be responsible for both procedures. The primary endpoint is (OS). The planned sample size was 920. Results: Between March 2010 and November 2013, 921 patients (LADG 462, ODG 459) were enrolled from 33 institutions. Operating time was longer in LADG than ODG (median 278 vs 194 min, p < 0.001). Blood loss was smaller in LADG than ODG (median 38 vs 115 ml, p < 0.001). There were no grade 3 or 4 intrao...