Laparoscopic Pylorus-preserving Gastrectomy Versus Distal Gastrectomy for Early Gastric Cancer: A Multicenter Randomized Controlled Trial (KLASS-04)

Objective:To evaluate the long-term outcomes of laparoscopic pylorus-preserving gastrectomy (LPPG) with laparoscopic distal gastrectomy (LDG) for early gastric cancer. Background:Pylorus-preserving gastrectomy is considered a function-preserving surgery for early gastric cancer. However, there has been no multicenter randomized controlled trial comparing pylorus-preserving gastrectomy with distal gastrectomy until now. Methods:A multicenter randomized controlled trial (KLASS-04) with 256 patients with cT1N0M0 gastric cancer located in the mid portion of the stomach was conducted. The primary endpoint was the incidence of dumping syndrome at postoperative 1 year. Secondary endpoints included survival and recurrence, gallstone formation, nutritional parameters, gastroscopic findings, and quality of life for 3 years. Results:In the intention-to-treat analyses, there was no difference in the incidence of dumping syndrome at 1 year postoperatively (13.2% in LPPG vs 15.8% in LDG, P = 0.622). Gallstone formation after surgery was significantly lower in LPPG than in LDG (2.33% vs 8.66%, P = 0.026). Hemoglobin (+0.01 vs -0.76 gm/dL, P < 0.001) and serum protein (-0.15 vs -0.35 gm/dL, P = 0.002) were significantly preserved after LPPG. However, reflux esophagitis (17.8% vs 6.3%, P = 0.005) and grade IV delayed gastric emptying (16.3% vs 3.9%, P = 0.001) were more common in LPPG. Changes in body weight and postoperative quality of life were not significantly different between groups. Three-year overall survival and disease-free survival were not different (1 case of recurrence in each group, P = 0.98). Conclusions:LPPG can be used as an alternative surgical option for cT1N0M0 gastric cancer in the mid portion of the stomach.