腹腔镜贲门括约肌保留胃切除术与远端胃切除术在早期胃癌中的比较：多中心随机对照试验（KLASS-04）

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

ANNALS OF SURGERY

影响因子:6.4

分区:医学1区 Top / 外科1区

发表日期:2025 Apr 01

作者: Hyuk-Joon Lee, Young-Woo Kim, Do Joong Park, Sang Uk Han, Keun Won Ryu, Hyung-Ho Kim, Woo Jin Hyung, Ji-Ho Park, Yun-Suhk Suh, Oh-Kyung Kwon, Wook Kim, Young-Kyu Park, Hong Man Yoon, Sang-Hoon Ahn, Seong-Ho Kong, Han-Kwang Yang

DOI: 10.1097/SLA.0000000000006503

摘要

本研究旨在评估腹腔镜贲门括约肌保留胃切除术（LPPG）与腹腔镜远端胃切除术（LDG）在早期胃癌中的长期疗效。贲门括约肌保留切除术被视为一种功能保存手术，用于早期胃癌。然而，迄今尚无多中心随机对照试验比较两者的效果。我们进行了一项多中心随机对照试验（KLASS-04），共纳入256例中部胃部cT1N0M0胃癌患者。主要终点为术后1年的贪食综合征发生率。次要终点包括生存率、复发情况、胆结石形成、营养指标、胃镜表现和3年的生活质量。在意向治疗分析中，术后1年的贪食综合征发生率无显著差异（LPPG组13.2%对比LDG组15.8%，P=0.622）。手术后胆结石形成在LPPG组明显低于LDG组（2.33%对8.66%，P=0.026）。血红蛋白（+0.01对-0.76 g/dL，P<0.001）和血清蛋白（-0.15对-0.35 g/dL，P=0.002）在LPPG组得到了显著保持。然而，反流性食管炎（17.8%对6.3%，P=0.005）和IV级延迟性胃排空（16.3%对3.9%，P=0.001）在LPPG组更为常见。体重变化和术后生活质量在两组间无显著差异。三年总体生存率和无病生存率无差异（每组各1例复发，P=0.98）。LPPG可作为中段cT1N0M0胃癌的替代手术方案。

Abstract

To evaluate the long-term outcomes of laparoscopic pylorus-preserving gastrectomy (LPPG) with laparoscopic distal gastrectomy (LDG) for early gastric cancer.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.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.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).LPPG can be used as an alternative surgical option for cT1N0M0 gastric cancer in the mid portion of the stomach.