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)。
Laparoscopic Pylorus Preserving Gastrectomy vs Distal Gastrectomy for Early Gastric Cancer; A Multicenter Randomized Controlled Trial (KLASS-04).
发表日期:2024 Sep 02
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
来源:
ANNALS OF SURGERY
摘要:
旨在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)的长期结果。PPG被认为是EGC的功能保留手术。然而,目前还没有比较PPG与DG的多中心随机对照试验。一项对256名位于胃中部的cT1N0M0胃癌患者进行的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。次要终点包括生存率和复发、胆结石形成、营养参数、胃镜检查结果和 3 年生活质量 (QOL)。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)。LPPG可作为胃中部cT1N0M0胃癌的替代手术选择。版权所有© 2024 Wolters Kluwer Health, Inc. 保留所有权利。
To evaluate the long-term outcomes of laparoscopic pylorus preserving gastrectomy (LPPG) with laparoscopic distal gastrectomy (LDG) for early gastric cancer (EGC).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.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.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).LPPG can be used as an alternative surgical option for cT1N0M0 gastric cancer in the mid portion of the stomach.Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.