Effect of Laparoscopic and Open Pancreaticoduodenectomy for Pancreatic or Periampullary Tumors: Three-year Follow-up of a Randomized Clinical Trial

作者全名：Qin, Tingting; Zhang, Hang; Pan, Shutao; Liu, Jun; Li, Dewei; Chen, Rufu; Huang, Xiaobing; Liu, Yahui; Liu, Jianhua; Cheng, Wei; Chen, Xuemin; Zhao, Wenxing; Li, Jingdong; Tan, Zhijian; Huang, Heguang; Li, Deyu; Zhu, Feng; Yu, Guangsheng; Zhou, Baoyong; Zheng, Shangyou; Tang, Yichen; Ke, Jianji; Liu, Xueqing; Chen, Botao; Chen, Weibo; Ma, Hongqin; Xu, Jian; Liu, Yifeng; Lin, Ronggui; Dong, Yadong; Yu, Yahong; Wang, Min; Qin, Renyi

作者地址：[Qin, Tingting; Zhang, Hang; Pan, Shutao; Zhu, Feng; Yu, Yahong; Wang, Min; Qin, Renyi] Huazhong Univ Sci & Technol, Affiliated Tongji Hosp, Dept Biliary Pancreat Surg, Tongji Med Coll, Wuhan, Hubei Province, Peoples R China; [Liu, Jun; Yu, Guangsheng] Shandong Prov Hosp, Dept Hepatopancreatobiliary Surg, Shandong, Peoples R China; [Li, Dewei; Zhou, Baoyong] Chongqing Med Univ, Dept Hepatobiliary Surg, Affiliated Hosp 1, Chongqing, Peoples R China; [Chen, Rufu; Zheng, Shangyou] Southern Med Univ, Guangdong Prov Peoples Hosp, Dept Pancreas Ctr, Dept Gen Surg,Guangdong Acad Med Sci, Guangzhou, Guangdong Provi, Peoples R China; [Huang, Xiaobing; Tang, Yichen] Army Med Univ, Dept Pancreat Hepatobiliary Surg, Affiliated Hosp 2, PLA, Chongqing, Peoples R China; [Liu, Yahui; Ke, Jianji] Jilin Univ, Dept Hepatobiliary & Pancreat Surg, Hosp 1, Jilin, Jilin, Peoples R China; [Liu, Jianhua; Liu, Xueqing] Hebei Med Univ, Hepatobiliary & Pancreat Surg Dept, Hosp 2, Shijiazhuang, Hebei Province, Peoples R China; [Cheng, Wei] Xiangyue Hosp, Natl Clin Ctr Schistosomiasis Treatment, Hunan Inst Parasit Dis, Yueyang, Hunan Province, Peoples R China; [Cheng, Wei; Chen, Botao] Hunan Normal Univ, Hunan Prov Peoples Hosp, Dept Hepatobiliary Surg, Affiliated Hosp 1, Changsha, Hunan Province, Peoples R China; [Chen, Xuemin; Chen, Weibo] Soochow Univ, Dept Hepatopancreatobiliary Surg, Affiliated Hosp 3, Changzhou, Jiangsu Provinc, Peoples R China; [Zhao, Wenxing; Ma, Hongqin] Xuzhou Med Univ, Dept Hepatopancreatobiliary Surg, Affiliated Hosp, Xuzhou, Jiangsu Provinc, Peoples R China; [Li, Jingdong; Xu, Jian] North Sichuan Med Coll, Affiliated Hosp, Dept Hepatobiliary Surg, Nanchong, Sichuan, Peoples R China; [Tan, Zhijian; Liu, Yifeng] Guangdong Hosp Tradit Chinese Med, Dept Hepatobiliary & Pancreat Surg, Guangzhou, Guangdong Provi, Peoples R China; [Huang, Heguang; Lin, Ronggui] Fujian Med Univ, Dept Gen Surg, Union Hosp, Fuzhou, Fujian Province, Peoples R China; [Li, Deyu; Dong, Yadong] Zhengzhou Univ, Henan Prov Peoples Hosp, Dept Hepatobiliary Pancreat Surg, Peoples Hosp, Zhengzhou, Henan Province, Peoples R China

通信作者：Wang, M; Qin, RY (通讯作者)，Huazhong Univ Sci & Technol, Affiliated Tongji Hosp, Dept Biliary Pancreat Surg, Tongji Med Coll, Wuhan, Hubei Province, Peoples R China.

来源：ANNALS OF SURGERY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001234160800014

JCR分区：Q1

影响因子：7.5

年份：2024

卷号：279

期号：4

开始页：605

结束页：612

文献类型：Article

关键词：laparoscopic; open; pancreaticoduodenectomy; randomized clinical trial; survival

摘要：Objective:This 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. Background:LPD 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. Methods:This 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. Results:Data 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. Conclusion:In patients with pancreatic or periampullary tumors, LPD performed by experienced surgeons resulted in a similar 3-year OS compared with OPD. Trial Registration:ClinicalTrials.gov Identifier: NCT03138213.

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