Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer

作者：Chang‐Ming Huang, Hao Liu, Yanfeng Hu, Yihong Sun, Xiangqian Su, Hui Cao, Jian-Kun Hu, Kuan Wang, Jian Suo, Kaixiong Tao, Xianli He, Hongbo Wei, Mingang Ying, Weiguo Hu, Xiaohui Du, Jiang Yu, Chao‐Hui Zheng, Fenglin Liu, Ziyu Li, Gang Zhao, Jiachen Zhang, Pingyan Chen, Guoxin Li, Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group, Yu Jiang, Changming Huang, Yihong Sun, Xiangqian Su, Hui Cao, Jian-Kun Hu, Kuan Wang, Jian Suo, Kaixiong Tao, Xianli He, Hongbo Wei, Mingang Ying, Weiguo Hu, Xiaohui Du, Yanfeng Hu, Hao Liu, Chao‐Hui Zheng, Ping Li, Jian‐Wei Xie, Fenglin Liu, Ziyu Li, Gang Zhao, Kun Yang, Chunxiao Liu, Haojie Li, Pingyan Chen, Jiafu Ji, Guoxin Li · 发表于：JAMA Surgery · 年份：2021 · DOI：10.1001/jamasurg.2021.5104 · 被引用次数：271 · 研究领域：Gastric Cancer Management and Outcomes、Gastrointestinal Tumor Research and Treatment、Minimally Invasive Surgical Techniques

Importance: It is not clear whether laparoscopic and open distal gastrectomy produce similar outcomes among patients with locally advanced gastric cancer. Data from a multicenter, randomized clinical trial (Chinese Laparoscopic Gastrointestinal Surgical Study [CLASS]-01) showed that laparoscopic distal gastrectomy did not result in inferior disease-free survival at 3 years compared with open distal gastrectomy. Objective: To report 5-year overall survival data from the CLASS-01 trial of laparoscopic vs open distal gastrectomy among patients with locally advanced gastric cancer. Design, Setting, and Patients: This was a noninferiority, open-label, randomized clinical trial conducted at 14 centers in China. A total of 1056 eligible patients with clinical stage T2, T3, or T4a gastric cancer without bulky nodes or distant metastases were enrolled from September 12, 2012, to December 3, 2014. Final follow-up was on December 31, 2019. Interventions: Participants were randomized in a 1:1 ratio after stratification by site, age, cancer stage, and histologic features to undergo either laparoscopic distal gastrectomy (n = 528) or open distal gastrectomy (n = 528) with D2 lymphadenectomy. Main Outcomes and Measures: The 5-year overall survival rates were updated to compare laparoscopic distal gastrectomy with open distal gastrectomy. All analyses were performed on an intention-to-treat basis. In addition, per-protocol and as-treated analyses were performed for overall survival. Results:...