Pancreaticoduodenectomy With or Without Braun Enteroenterostomy: Comparison of Postoperative Panc… (NCT01481753) | Clinical Trial Compass
TerminatedNot Applicable
Pancreaticoduodenectomy With or Without Braun Enteroenterostomy: Comparison of Postoperative Pancreatic Fistula and Delayed Gastric Emptying
Stopped: last patient recruited Feb 2015,completion of data review; study data do not meet statistical significance to answer proposed study question
United States341 participantsStarted 2009-12
Plain-language summary
The investigators plan to perform a prospective randomized, head-to-head trial to test the hypothesis that the addition of Braun enteroenterostomy to standard pancreaticoduodenectomy (PD) reconstruction can decrease the rates of Postoperative Pancreatic Fistula (POPF) and/or Delayed Gastric Emptying (DGE).
Who can participate
Age range
18 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:
* Patients undergoing pancreaticoduodenectomy surgery at Johns Hopkins Hospital
Exclusion Criteria:
* Pregnant women
* Patients under the age of 18
* adults lacking ability to consent,
* patients scheduled for laparoscopic whipple surgery
* non-english-speakers, and
* prisoners
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 was terminated before it finished — does that mean there wasn't enough evidence gathered to know whether adding a Braun enteroenterostomy actually reduces pancreatic fistula risk, and how does that uncertainty affect my surgical planning?
2Since this study was specifically looking at pancreaticoduodenectomy (Whipple surgery), can you walk me through whether a Braun enteroenterostomy is something you would or wouldn't include in my procedure, and what your own experience or current evidence suggests about its impact on complications like delayed gastric emptying?
3Pancreatic fistula and delayed gastric emptying are both serious complications after this type of surgery — what steps in my specific case are being taken to reduce those risks, regardless of what this trial found?
4Because this trial was terminated, are there other completed studies or current surgical standards that better answer whether the Braun enteroenterostomy modification is beneficial, and should I be seeking care at a high-volume pancreatic surgery center where these outcomes are routinely tracked?
5Given that this trial never reached a conclusion, is standard pancreaticoduodenectomy without the Braun modification still considered the safer or more predictable option for someone in my situation, or is there a reason my surgeon might still consider adding it?
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
Decreased rates of pancreatic fistula in surgeries adding Braun enteroenterostomy
Timeframe: patients will be followed during hospital stay and interviewed at 90 days +/- 2 weeks post surgery