A Prospective Randomized Controlled Multicenter Trial of Delayed Gastric Emptying (DGE) After Pan… (NCT01460550) | Clinical Trial Compass
UnknownPhase 3
A Prospective Randomized Controlled Multicenter Trial of Delayed Gastric Emptying (DGE) After Pancreaticoduodenectomy Evaluating by Gastrointestinal Reconstruction
Japan240 participantsStarted 2011-11
Plain-language summary
The purpose of this study is to evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction.
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:
* patients with pancreatic-biliary disease who undergo pancreaticoduodenectomy
Exclusion Criteria:
* patients who have the history of gastrectomy
* patients who have severe cardiorespiratory dysfunction
* patients who have liver cirrhosis or are receiving dialysis
* patients who were diagnosed inadequacy for this study by a physician
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 different ways of reconstructing the digestive tract after a Whipple procedure to see which approach reduces the risk of delayed gastric emptying — can you explain what delayed gastric emptying actually feels like after surgery, and how common it is with the technique you typically use?
2Since this is a Phase 3 trial, there should already be some safety data from earlier studies — what do we know so far about whether one reconstruction method is safer or more effective than the others being tested?
3The recruitment status for this trial is listed as unknown, so can you find out whether this study is still actively enrolling patients, and if not, whether its findings have already influenced how you approach the Whipple procedure?
4If I were to consider a trial like this one, how would being randomized to a specific reconstruction method affect my care — would I have any say in which approach I receive, or would that be determined entirely by chance?
5Given that delayed gastric emptying can significantly extend hospital stays and recovery time, are there other options or surgical techniques outside of this trial that you'd recommend discussing before deciding on the best reconstruction approach 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
Incident rate of delayed gastric emptying
Timeframe: during hospital stay after surgery, an expected average of 3 weeks