Laparoscopic versus open pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: study protocol for a multicentre randomised controlled trial

作者全名："Pan, Shutao; Qin, Tingting; Yin, Taoyuan; Yu, Xianjun; Li, Jing; Liu, Jun; Zhao, Wenxing; Chen, Xuemin; Li, Dewei; Liu, Jianhua; Li, Jingdong; Liu, Yahui; Zhu, Feng; Wang, Min; Zhang, Hang; Qin, Renyi"

作者地址："[Pan, Shutao; Qin, Tingting; Yin, Taoyuan; Zhu, Feng; Wang, Min; Zhang, Hang; Qin, Renyi] Huazhong Univ Sci & Technol, Affiliated Tongji Hosp, Tongji Med Coll, Dept Biliary Pancreat Surg, Wuhan, Hubei, Peoples R China; [Yu, Xianjun] Fudan Univ, Dept Pancreat Surg, Shanghai Canc Ctr, Shanghai, Peoples R China; [Li, Jing] Army Med Univ, Dept Pancreat Hepatobiliary Surg, Affiliated Hosp 2, PLA, Chongqing, Peoples R China; [Liu, Jun] Shandong Prov Hosp, Dept Hepatopancreatobiliary Surg, Jinan, Shandong, Peoples R China; [Zhao, Wenxing] Xuzhou Med Coll, Dept Gen Surg, Affiliated Hosp, Xuzhou, Jiangsu, Peoples R China; [Chen, Xuemin] Soochow Univ, Dept Hepatopancreatobiliary Surg, Affiliated Hosp 3, Changzhou, Jiangsu, Peoples R China; [Li, Dewei] Chongqing Univ Canc Hosp, Dept Hepatobiliary & Pancreat Oncol, Chongqing, Peoples R China; [Li, Dewei] Chongqing Med Univ, Dept Hepatobiliary Surg, Affiliated Hosp 1, Chongqing, Peoples R China; [Liu, Jianhua] Hebei Med Univ, Hosp 2, Dept Hepatopancreatobiliary Surg, Shijiazhuang, Hebei, Peoples R China; [Li, Jingdong] North Sichuan Med Coll, Affiliated Hosp, Dept Pancreat Hepatobiliary Surg, Nanchong, Sichuan, Peoples R China; [Liu, Yahui] Jilin Univ First Hosp, Dept Hepatobiliary & Pancreat Surg, Changchun, Jilin, 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, Wuhan, Hubei, Peoples R China."

来源：BMJ OPEN

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000778983400006

JCR分区：Q1

影响因子：2.9

年份：2022

卷号：12

期号：4

开始页：　

结束页：　

文献类型：Article

关键词：　

摘要："Introduction Pancreatic cancer is one of the deadliest cancers and pancreaticoduodenectomy (PD) is recommended as the optimal operation for resectable pancreatic head cancer. Minimally invasive surgery, which initially emerged as hybrid-laparoscopy and recently developed into total laparoscopy surgery, has been widely used for various abdominal surgeries. However, controversy persists regarding whether laparoscopic PD (LPD) is inferior to open PD (OPD) for resectable pancreatic ductal adenocarcinoma (PDAC) treatment. Further studies, especially randomised clinical trials, are warranted to compare these two surgical techniques. Methods and analysis The TJDBPS07 study is designed as a prospective, randomised controlled, parallel-group, open-label, multicentre noninferiority study. All participating pancreatic surgical centres comprise specialists who have performed no less than 104 LPDs and OPD5, respectively. A total of 200 strictly selected PD candidates diagnosed with PDAC will be randomised to receive LPD or OPD. The primary outcome is the 5-year overall survival rate, whereas the secondary outcomes include overall survival, disease-free survival, 90-day mortality, complication rate, comprehensive complication index, length of stay and intraoperative indicators. We hypothesise that LPD is not inferior to OPD for the treatment of resectable PDAC. The enrolment schedule is estimated to be 2 years and follow-up for each patient will be 5 years. Ethics and dissemination This study received approval from the Tongji Hospital Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology, and monitor from an independent third-party organisation. Results of this trial will be presented in international meetings and published in a peer-reviewed journal."

基金机构："National Natural Science Foundation of China [82073249, 81874205, 81773160]; Tongji Hospital Clinical Research Flagship Program [2019CR203]"

基金资助正文："The study was supported by grants from The National Natural Science Foundation of China (82073249, 81874205, 81773160), Tongji Hospital Clinical Research Flagship Program (2019CR203)."