Total laparoscopic pancreaticoduodenectomy versus open pancreaticoduodenectomy (TJDBPS01): study protocol for a multicentre, randomised controlled clinical trial

作者：Hang Zhang, Yechen Feng, Junfang Zhao, Rufu Chen, Xuemin Chen, Xinmin Yin, Wei Cheng, Dewei Li, Jingdong Li, Xiaobing Huang, Jing Li, Jianhua Liu, Jun Liu, Yahui Liu, Zhijian Tan, Wenxing Zhao, Heguang Huang, Deyu Li, Yahong Yu, Min Wang, Renyi Qin · 发表于：BMJ Open · 年份：2020 · DOI：10.1136/bmjopen-2019-033490 · 被引用次数：26 · 研究领域：Pancreatic and Hepatic Oncology Research、Minimally Invasive Surgical Techniques、Cholangiocarcinoma and Gallbladder Cancer Studies

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 ...