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Randomized Controlled Trial
Effect of Laparoscopic and Open Pancreatoduodenectomy for Pancreatic or Periampullary Tumors: Three-year Follow-up of a Randomized Clinical Trial.
- Tingting Qin, Hang Zhang, Shutao Pan, Jun Liu, Dewei Li, Rufu Chen, Xiaobing Huang, Yahui Liu, Jianhua Liu, Wei Cheng, Xuemin Chen, Wenxing Zhao, Jingdong Li, Zhijian Tan, Heguang Huang, Deyu Li, Feng Zhu, Guangsheng Yu, Baoyong Zhou, Shangyou Zheng, Yichen Tang, Jianji Ke, Xueqing Liu, Botao Chen, Weibo Chen, Hongqin Ma, Jian Xu, Yifeng Liu, Ronggui Lin, Yadong Dong, Yahong Yu, Min Wang, Renyi Qin, and Minimally Invasive Treatment Group in the Pancreatic Disease Branch of China’s International Exchange and Promotion Association for Medicine and Healthcare (MITG-P-CPAM).
- Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China.
- Ann. Surg. 2024 Apr 1; 279 (4): 605612605-612.
ObjectiveThis study aimed to estimate whether the potential short-term advantages of laparoscopic pancreaticoduodenectomy (LPD) could allow patients to recover in a more timely manner and achieve better long-term survival than with open pancreaticoduodenectomy (OPD) in patients with pancreatic or periampullary tumors.BackgroundLPD has been demonstrated to be feasible and may have several potential advantages over OPD in terms of shorter hospital stay and accelerated recovery than OPD.MethodsThis noninferiority, open-label, randomized clinical trial was conducted in 14 centers in China. The initial trial included 656 eligible patients with pancreatic or periampullary tumors enrolled from May 18, 2018, to December 19, 2019. The participants were randomized preoperatively in a 1:1 ratio to undergo either LPD (n=328) or OPD (n=328). The 3-year overall survival (OS), quality of life, which was assessed using the 3-level version of the European Quality of Life-5 Dimensions, depression, and other outcomes were evaluated.ResultsData from 656 patients [328 men (69.9%); mean (SD) age: 56.2 (10.7) years] who underwent pancreaticoduodenectomy were analyzed. For malignancies, the 3-year OS rates were 59.1% and 54.3% in the LPD and OPD groups, respectively ( P =0.33, hazard ratio: 1.16, 95% CI: 0.86-1.56). The 3-year OS rates for others were 81.3% and 85.6% in the LPD and OPD groups, respectively ( P =0.40, hazard ratio: 0.70, 95% CI: 0.30-1.63). No significant differences were observed in quality of life, depression and other outcomes between the 2 groups.ConclusionIn patients with pancreatic or periampullary tumors, LPD performed by experienced surgeons resulted in a similar 3-year OS compared with OPD.Trial RegistrationClinicalTrials.gov Identifier: NCT03138213.Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.
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