与开腹手术相比，腹腔镜胰十二指肠切除术的疗效缺乏有力的证据。本研究旨在比较腹腔镜和开腹胰十二指肠切除术的功能恢复 (FR) 时间。这项务实、多中心、随机对照 3 期试验在七个三级中心进行。壶腹周围肿瘤患者采用区组设计以 1:1 的比例进行随机分组，并按胰瘘风险进行分层。参与者被随机分配接受由胰腺外科医生专家进行的开腹或腹腔镜胰十二指肠切除术。主要结果是达到 FR 的时间，定义为在所有五个领域实现 FR 之前的天数。次要终点包括围手术期和短期肿瘤学结果。2019年3月至2022年6月期间，252名患者被随机分配到腹腔镜组（n=125）或开腹组（n=127）。报告了 235 名患者的主要结果。与开腹组相比，腹腔镜组的平均 FR 时间更短（7.7 天 vs. 9.0 天，P=0.03）。与开腹组相比，腹腔镜组表现出更高的 FR 累积率（风险比，1.34；95% 置信区间，1.03-1.74；P=0.02）。两组之间的严重并发症、R0 切除、回收的淋巴结数量和短期生存率相当。对于由经验丰富的外科医生选择的患者，腹腔镜胰十二指肠切除术在 FR 时间上比开腹手术表现出一定的优势。版权所有 © 2024 ）。由 Wolters Kluwer Health, Inc. 出版

There is a lack of robust evidence on the efficacy of laparoscopic pancreatoduodenectomy compared to open surgery. This study was aimed to compare time to functional recovery (FR) between laparoscopic and open pancreatoduodenectomy.This pragmatic, multicenter, randomized controlled phase 3 trial was conducted in seven tertiary centers. Patients with periampullary tumors were randomized using a block design in a 1:1 ratio and stratified by pancreatic fistula risk. Participants were randomized to undergo open or laparoscopic pancreatoduodenectomy by expert pancreatic surgeons. The primary outcome was the time to FR, defined as the number of days until FR was achieved in all five domains. The secondary endpoints included perioperative and short-term oncological outcomes.Between March 2019 and June 2022, 252 patients were randomly assigned to the laparoscopic (n=125) or open groups (n=127). Primary outcomes were reported in 235 patients. The mean time to FR was shorter in laparoscopic group compared to the open group (7.7 d vs. 9.0 d, P=0.03). Laparoscopic group exhibited a higher cumulative rate of FR compared to the open group (Hazard ratio,1.34; 95% confidence interval, 1.03-1.74; P=0.02). Severe complications, R0 resection, the number of retrieved lymph nodes and short-term survival rates were comparable between the two groups.Laparoscopic pancreatoduodenectomy demonstrated modest advantages in FR time over open surgery for selected patients with experienced surgeons.Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.