医学
哨兵节点
胃切除术
临床终点
随机对照试验
胃
外科
胃癌
癌症
临床试验
内科学
乳腺癌
作者
Hoon Hur,Young Joon Lee,Young‐Woo Kim,Jin Sik Min,Hong Man Yoon,Ji Yeong An,Bang Wool Eom,Gyu Seok Cho,Youngkyu Park,Mi Ran Jung,Ji-Ho Park,Woo Jin Hyung,Sang-Ho Jeong,Myeong‐Cherl Kook,Mira Han,Byung-Ho Nam,Keun Won Ryu
出处
期刊:Annals of Surgery
[Ovid Technologies (Wolters Kluwer)]
日期:2024-01-25
被引量:4
标识
DOI:10.1097/sla.0000000000006219
摘要
Objective: This study aimed to compare laparoscopic standard gastrectomy (LSG) and laparoscopic sentinel node navigation surgery (LSNNS) for EGC in terms of 5-year long-term oncologic outcomes. Summary Background Data: The oncological safety of LSNNS for early gastric cancer (EGC) has not been confirmed. Three-year disease-free survival (DFS), which is the primary endpoint of the phase III multicenter randomized controlled clinical trial (SEntinel Node ORIented Tailored Approach [SENORITA] trial), did not show the non-inferiority of LSNNS relative to LSG. Methods: The SENORITA trial, a multicenter randomized clinical trial, was designed to show that LSNNS is non-inferior to LSG in terms of 3-year DFS. In the present study, we collected 5-year follow-up data from 527 patients recruited in the SENORITA trial as the full analysis set (FAS). Disease-free survival (DFS), overall survival (OS), disease-specific survival (DSS), and recurrence patterns were evaluated using the FAS of both LSG (n=269) and LSNNS (n=258). Results: The 5-year DFS was not significantly different between the LSG and LSNNS groups ( P =0.0561). During the 5-year follow-up, gastric cancer-related events, such as metachronous cancer, were more frequent in the LSNNS group than in the LSG group. However, ten recurrent cancers in the remnant stomach of both groups were curatively resected by additional gastrectomy and one by additional endoscopic resection. Two of the 198 patients who underwent local resection for stomach preservation based on the LSNNS results developed distant metastasis. However, there was no statistically significant difference in the 5-year OS and DSS ( P =0.7403 and P =0.9586, respectively) between the two groups. Conclusion: The 5-year DFS, DSS and OS did not differ significantly between the two groups. Considering the benefits of LSNNS on postoperative quality of life, LSNNS could be recommended as an alternative treatment option for EGC.
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