早期胃癌的腹腔镜幽门螺杆菌胃切除术与胃胃切除术：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)
影响因子:6.40000
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
摘要
为了评估早期胃癌的腹腔镜远端胃切除术（LDG）的腹腔镜幽门螺杆菌胃切除术（LPPG）的长期结局。杀菌性胃切除术被认为是早期胃癌的功能保护手术。然而，到目前为止，还没有进行多中心随机对照试验，该试验与256例CT1N0M0胃癌患者进行了多中心随机对照试验（Klass-04）的比较。主要终点是术后1年倾倒综合症的发生率。次要终点包括生存和复发，胆结石形成，营养参数，胃镜检查和3年的生活质量。在意图进行治疗的分析中，术后1年倾倒综合征的发生率没有差异（LPPG中13.2％的LPPG vs 15.8％在LDG中为15.8％，在LDG中，P = 0.622）。 LPPG手术后的胆结石形成明显低于LDG（2.33％，而8.66％，P = 0.026）。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）在LPPG之后得到了显着保留。但是，回流食管炎（17.8％vs 6.3％，P = 0.005）和IV级延迟胃排空（16.3％vs 3.9％，P = 0.001）在LPPG中更为常见。两组之间体重的变化和术后生活质量的变化并没有显着差异。三年的总生存期和无疾病的生存率并没有差异（每组中的1例复发，p = 0.98）.LPPG可以用作胃中中部CT1N0M0胃癌的替代手术选择。
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.