Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short term Outcomes From a Multicenter Randomized Controlled Trial (KLASS 01)
OBJECTIVE To determine the safety of laparoscopy assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG) in patients with clinical stage I gastric cancer in Korea. BACKGROUND There is still a lack of large scale, multicenter randomized trials regarding the safety of LADG. METHODS A large scale, phase 3, multicenter, prospective randomized controlled trial was conducted. The primary end point was 5 year overall survival. Morbidity within 30 postoperative days and surgical mortality were compared to evaluate the safety of LADG as a secondary end point RESULTS A total of 1416 patients were randomly assigned to the LADG group (n 705) or the ODG group (n 711) between February 1, 2006, and August 31, 2010, and 1384 patients were analyzed for modified intention to treat analysis (ITT) and 1256 were eligible for per protocol (PP) analysis (644 and 612, respectively) In the PP analysis, 6 patients (0.9% needed open conversion in the LADG group. The overall complication rate was significantly lower in the LADG group (LADG vs ODG; 13.0% vs 19.9% P 0.001) 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 0.001) The major intra abdominal complication (7.6% vs 10.3% P 0.095) and mortality rates (0.6% vs 0.3% P 0.687) were similar between the 2 groups. Modified ITT 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.
Annals of surgery