Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial
机构：[1]Department of Biliary-Pancreatic Surgery, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China华中科技大学同济医学院附属同济医院[2]Department of General Surgery, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China中山大学附属第二医院[3]Department of Hepatobiliary Pancreatic Surgery, Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China广东省人民医院[4]Department of Pancreaticobiliary Surgery, Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China[5]Department of Hepatobiliary Surgery, Hunan Provincial People's Hospital, Changsha, Hunan, China[6]Department of Hepatobiliary Surgery, Chongqing Medical University First Affiliated Hospital, Chongqing, Sichuan, China重庆医科大学附属第一医院[7]Department of Pancreatico-Hepatobiliary Surgery, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China[8]Department of Pancreatico-Hepatobiliary Surgery, The Second Affiliated Hospital, Army Medical University, Chongqing, Chongqing, China[9]Department of Hepato–Pancreato–Biliary Surgery, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China[10]Department of Hepato–Pancreato–Biliary Surgery, Shandong Provincial Hospital, Jinan, Shandong, China[11]Department of Hepatobiliary and Pancreatic Surgery, Jilin University First Hospital, Changchun, Jilin, China[12]Department of Hepatobiliary and Pancreatic Surgery, Guangdong Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, China大德路总院外科大德路总院外一科广东省中医院[13]Department of Hepato–Pancreato–Biliary Surgery, Xuzhou Medical College Affiliated Hospital, Xuzhou, Jiangsu, China[14]Department of Hepato–Pancreato–Biliary Surgery, Fujian Medical University Union Hospital, Xiamen, Fujian, China[15]Department of Hepatobiliary Pancreatic Surgery, Henan Provincial People's Hospital, Zhengzhou, Henan, China
Introduction Pancreatoduodenectomy (PD) is one of the most complex abdominal operations to perform, and it is usually conducted for tumours of the periampullary region and chronic pancreatitis. Minimally invasive surgery has been progressively being developed for pancreatic surgery, first with the advent of hybrid-laparoscopy and recently with total laparoscopic surgery. Issues including the safety and efficacy of total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD) are currently being debated. Studies comparing these two surgical techniques are emerging, and large randomised controlled trials (RCTs) are lacking but are clearly required. Methods and analysis TJDBPS01 is a multicentre, prospective, randomised controlled, parallel-group, superiority trial in 14 centres with pancreatic surgery experts who have performed >= 104 TLPDs and OPDs. A total of 656 patients who will undergo PD are randomly allocated to the TLPD group or OPD group in a 1:1 ratio. The trial hypothesis is that TLPD has superior or equivalent safety and advantages in postoperative recovery compared with OPD. The primary outcome is the postoperative length of stay. Ethics and dissemination The Instituitional Review Board Approval of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology has approved this trial and will be routinely monitoring the trial at frequent intervals, as will an independent third-party organisation. Any results from this trial (publications, conference presentations) will be published in peer-reviewed journals and conference proceedings.
基金：
Hubei Natural Science FoundationNatural Science Foundation of Hubei Province [WJ2017Z010]; Tongji Hospital Clinical Research Flagship Program [2019CR203]
第一作者机构：[1]Department of Biliary-Pancreatic Surgery, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
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推荐引用方式(GB/T 7714)：
Zhang Hang,Feng Yechen,Zhao Junfang,et al.Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial[J].BMJ OPEN.2020,10(2):doi:10.1136/bmjopen-2019-033490.
APA：
Zhang, Hang,Feng, Yechen,Zhao, Junfang,Chen, Rufu,Chen, Xuemin...&Qin, Renyi.(2020).Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial.BMJ OPEN,10,(2)
MLA：
Zhang, Hang,et al."Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial".BMJ OPEN 10..2(2020)
