OBJECTIVE To evaluate the long-term outcomes of laparoscopic pylorus preserving gastrectomy (LPPG) with laparoscopic distal gastrectomy (LDG) for early gastric cancer (EGC). SUMMARY BACKGROUND DATA PPG is considered as a function preserving surgery for EGC. However, there has been no multicenter randomized controlled trial comparing PPG with DG 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 (QOL) for 3 years. RESULTS In the intention-to-treat analyses, there was no difference in the incidence of dumping syndrome at one 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 QOL were not significantly different between groups. Three-year overall survival and disease-free survival were not different (1 case of recurrence of 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.

中文翻译：

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腹腔镜保留幽门胃切除术与远端胃切除术治疗早期胃癌；多中心随机对照试验（KLASS-04）。


目的 评估腹腔镜保留幽门胃切除术（LPPG）与腹腔镜远端胃切除术（LDG）治疗早期胃癌（EGC）的长期疗效。概要背景数据 PPG 被认为是 EGC 的功能保留手术。然而，迄今为止还没有比较PPG与DG的多中心随机对照试验。方法对256例位于胃中部的cT1N0M0胃癌患者进行多中心随机对照试验（KLASS-04）。主要终点是术后 1 年倾倒综合征的发生率。次要终点包括生存和复发、胆结石形成、营养参数、胃镜检查结果和 3 年生活质量 (QOL)。结果 在意向治疗分析中，术后一年倾倒综合征的发生率没有差异（LPPG 为 13.2%，LDG 为 15.8%，P=0.622）。 LPPG术后胆结石形成率显着低于LDG（2.33% vs. 8.66%，P=0.026）。 LPPG 后血红蛋白（+0.01 vs. -0.76 gm/dL，P<0.001）和血清蛋白（-0.15 vs. -0.35 gm/dL，P=0.002）显着保留。然而，反流性食管炎（17.8% vs. 6.3%，P=0.005）和IV级胃排空延迟（16.3% vs. 3.9%，P=0.001）在LPPG中更为常见。各组之间体重变化和术后生活质量没有显着差异。三年总生存率和无病生存率无差异（各组复发1例，P=0.98）。结论 LPPG 可作为胃中部 cT1N0M0 胃癌的替代手术选择。