External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent After Pancreaticoduode… (NCT01634971) | Clinical Trial Compass
UnknownPhase 2
External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent After Pancreaticoduodenectomy (EDIDPD)
China120 participantsStarted 2012-05
Plain-language summary
Postoperative pancreatic fistula (POPF) and other surgical complications are common after pancreatoduodenectomy (PD) and POPF is a major complication. The drainage of pancreatic duct is important and a stent is usually placed in the operation, but it is still controversial whether the stent drainage is internal or external.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age more than 18 years.
* Received pancreatoduodenectomy.
* Informed consent has been signed.
Exclusion Criteria:
* Age less than 18 years
* Emergency surgery
* Past history of pancreatic surgery.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing two different ways of draining the pancreatic duct during a Whipple procedure — one draining fluid outside the body and one using an internal stent — so which approach would my surgeon use in my specific case, and what are the known risks of each method?
2Since this is a Phase 2 trial, the safety and effectiveness data are still relatively early — what does my surgeon know so far about how each drainage method affects the risk of developing a pancreatic fistula after surgery?
3The trial is measuring pancreatic fistula rates within the first two weeks after the operation, but what happens to my follow-up and care if I develop a fistula or another complication during that window?
4Given that the recruitment status of this trial is listed as unknown, is this study still actively enrolling patients, and would my surgeon even be able to offer it to me at this time?
5Compared to enrolling in this trial, what is my surgeon's current standard approach to pancreatic duct drainage during a Whipple procedure, and would that standard approach be a safer or more predictable option for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the rate of Postoperative pancreatic fistula within 2 weeks after operation
Timeframe: within 2 weeks after operation
Trial details
NCT IDNCT01634971
SponsorTianjin Medical University Cancer Institute and Hospital