4 Background: Laparoscopy assisted distal gastrectomy (LADG) is widely performed for gastric cancer in Eastern countries, although large scale prospective data are still lacking. We conducted a phase III, multicenter randomized controlled trial (KLASS-01) to compare the short and long term outcomes of LADG versus open distal gastrectomy (ODG) in patients with clinical stage I gastric cancer in Korea. Methods: The primary end point was 5-year overall survival. The morbidity within 30 postoperative days and the surgical mortality were compared to evaluate the safety of LADG as a secondary end point. A total of 1,416 patients were randomly assigned to the LADG group (n = 705) or the ODG group (n = 711) between Feb 1, 2006 and Aug 31, 2010. Results: 1,256 were eligible for per protocol (PP) analysis (644 and 612, respectively). The overall complication rate was significantly lower in the LADG group (LADG vs. ODG; 13.0% vs. 19.9%, P =.001). In detail, the wound complication rate of the LADG group was significantly lower than that of the ODG group (3.1% vs. 7.7%, P <.001). The major intra-abdominal complication (7.6% vs. 10.3%, P =.095) and mortality rates (0.6% vs. 0.3%, P =.450) were similar between groups. Modified intention-to-treat analysis showed similar results with PP analysis. Conclusions: LADG for patients with clinical stage I gastric cancer is safe and has a benefit of lower occurrence of wound complication compared with conventional ODG. Clinical trial information: NCT00452751.
ERRATUM: Correction for the number of the recruited patients and the participating institutions. Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01)
