Short-Term Outcomes Following Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Pancreatic Ductal Adenocarcinoma A Randomized Clinical Trial

作者全名："Wang, Min; Pan, Shutao; Qin, Tingting; Xu, Xiaowu; Huang, Xiaobing; Liu, Jun; Chen, Xuemin; Zhao, Wenxing; Li, Jingdong; Liu, Chen; Li, Dewei; Liu, Jianhua; Liu, Yahui; Zhou, Baoyong; Zhu, Feng; Ji, Shunrong; Cheng, He; Li, Zheng; Li, Jing; Tang, Yichen; Peng, Xuehui; Yu, Guangsheng; Chen, Weibo; Ma, Hongqin; Xiong, Yongfu; Meng, Lingyu; Lu, Pei; Zhang, Zhenxiong; Yu, Xianjun; Zhang, Hang; Qin, Renyi"

作者地址："[Wang, Min; Pan, Shutao; Qin, Tingting; Zhu, Feng; Zhang, Zhenxiong; Zhang, Hang; Qin, Renyi] Huazhong Univ Sci & Technol, Affiliated Tongji Hosp, Tongji Med Coll, Dept Biliary Pancreat Surg, 1095 Jiefang Ave, Wuhan 430030, Hubei, Peoples R China; [Xu, Xiaowu; Liu, Chen; Ji, Shunrong; Cheng, He; Li, Zheng; Yu, Xianjun] Fudan Univ, Shanghai Canc Ctr, Dept Pancreat Surg, Shanghai, Peoples R China; [Huang, Xiaobing; Li, Jing; Tang, Yichen; Peng, Xuehui] Army Med Univ, Affiliated Hosp 2, Dept Hepatobiliary Surg, Chongqing, Peoples R China; [Liu, Jun; Yu, Guangsheng] Shandong First Med Univ, Shandong Prov Hosp, Dept Liver Transplantat & Hepatobiliary Surg, Jinan, Shandong, Peoples R China; [Liu, Jun] Shandong Univ, Shandong Prov Hosp, Dept Liver Transplantat & Hepatobiliary Surg, Jinan, Shandong, Peoples R China; [Chen, Xuemin; Chen, Weibo] Soochow Univ, Affiliated Hosp 3, Dept Hepatopancreatobiliary Surg, Suzhou, Jiangsu, Peoples R China; [Zhao, Wenxing; Ma, Hongqin] Xuzhou Med Univ, Affiliated Hosp, Dept Hepatopancreatobiliary Surg, Xuzhou, Peoples R China; [Li, Jingdong; Xiong, Yongfu] North Sichuan Med Coll, Affiliated Hosp, Dept Pancreat Hepatobiliary Surg, Nanchong, Sichuan, Peoples R China; [Li, Dewei; Zhou, Baoyong] Chongqing Med Univ, Affiliated Hosp 1, Dept Hepatobiliary Surg, Chongqing, Peoples R China; [Li, Dewei] Chongqing Univ Canc Hosp, Dept Hepatobiliary Pancreat Tumor Ctr, Chongqing, Peoples R China; [Liu, Jianhua] Hebei Med Univ, Hosp 2, Dept Hepatobiliary Surg, Shijiazhuang, Hebei, Peoples R China; [Liu, Yahui; Meng, Lingyu] First Hosp Jilin Univ, Gen Surg Ctr, Dept Hepatobiliary & Pancreat Surg, Changchun, Jilin, Peoples R China; [Lu, Pei] Huazhong Univ Sci & Technol, Affiliated Tongji Hosp, Tongji Med Coll, Dept Anesthesiol, Wuhan, Hubei, Peoples R China"

通信作者："Qin, RY (通讯作者)，Huazhong Univ Sci & Technol, Affiliated Tongji Hosp, Tongji Med Coll, Dept Biliary Pancreat Surg, 1095 Jiefang Ave, Wuhan 430030, Hubei, Peoples R China."

来源：JAMA SURGERY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001094021800005

JCR分区：Q1

影响因子：15.7

年份：2023

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：　

摘要："<bold>Importance</bold> The safety and efficacy of laparoscopic pancreaticoduodenectomy for pancreatic ductal adenocarcinoma remain controversial.<bold>Objective</bold> To compare laparoscopic and open pancreaticoduodenectomy performed by experienced surgeons in patients with pancreatic ductal adenocarcinoma.<bold>Design, Setting, and Participants</bold> This was a noninferiority, open-label randomized clinical trial between September 20, 2019 and March 20, 2022, at 10 hospitals in China. A total of 412 adult patients were assessed for eligibility; 200 patients with histologically confirmed or clinically diagnosed pancreatic ductal adenocarcinoma who were eligible to undergo pancreaticoduodenectomy were enrolled. Study recruitment is complete, and follow-up is ongoing. This article reports prespecified early safety results from the trial.<bold>Interventions</bold> Participants were randomized in a 1:1 ratio to undergo either laparoscopic or open pancreaticoduodenectomy, to be performed by experienced surgeons who had already performed at least 104 laparoscopic pancreaticoduodenectomy operations.<bold>Main Outcomes and Measures</bold> The primary end point is 5-year overall survival, but the data for this end point are not yet mature; thus, secondary short-term outcomes, including operative findings, complications, mortality, and oncological results are reported here. The outcomes were analyzed according to a modified intention-to-treat and per-protocol principle.<bold>Results</bold> Among 412 patients for eligibility, 200 patients were enrolled and randomly assigned 1:1 to have laparoscopic pancreaticoduodenectomy or open pancreaticoduodenectomy. The mean (SD) age was 61.3 (9.3) years, and 78 participants (39%) were female. Laparoscopic procedures had longer operative times (median [IQR], 330.0 [287.5-405.0] minutes vs 297.0 [245.0-340.0] minutes; P < .001). Patients in the laparoscopic group lost less blood than those in the open group (median [IQR], 145.0 [100.0-200.0] mL vs 200.0 [100.0-425.0] mL; P = .02). Ninety-day mortality occurred in 2 of 100 patients in the laparoscopic group and 0 of 100 patients in the open group. There was no difference in the rates of complications of the Clavien-Dindo grades III-IV (n = 17 [17.0%] vs n = 23 [23.0%]; P = .29), comprehensive complication index (median [IQR], 0.0 [0.0-22.6] vs 8.7 [0.0-26.2]; P = .79) or median (IQR) postoperative length of stay (14.0 [11.0-17.0] days vs 14.0 [12.0-18.5] days; P = .37) between the 2 groups.<bold>Conclusions and Relevance</bold> Laparoscopic pancreaticoduodenectomy performed by experienced surgeons in high-volume specialized institutions resulted in similar short-term outcomes compared with open pancreaticoduodenectomy among patients with pancreatic ductal adenocarcinoma."

基金机构："National Key Research and Development Program of China [2022YFA1105300-03]; National Natural Science Foundation of China [82273442, 82273438, 82073249, 81773160, 81874205]; Key Research and Development Program of Hubei Province [2021BCA117]; Tongji Hospital Clinical Research Flagship Program [2019CR203]"

基金资助正文："This study was supported by grants from the National Key Research and Development Program of China(2022YFA1105300-03), National Natural Science Foundation of China (82273442, 82273438, 82073249, 81773160, and 81874205), the Key Research and Development Program of Hubei Province (2021BCA117), and the Tongji Hospital Clinical Research Flagship Program (2019CR203)"