Surgery Clinical Trial
Official title:
Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy(TJDBPS01) a Multicenter Randomized Controlled Trial
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 randomized
controlled trials (RCTs) are lacking but are clearly required.
Methods and analysis TJDBPS01 is a multicentre, prospective, randomized controlled,
parallel-group, superiority trial in fourteen 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 (LOS).
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 organization. Any results from this trial (publications, conference
presentations) will be published in peer-reviewed journals and conference proceedings.
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