TerminatedPhase 2

Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy

Stopped: Investigator and study team chose to end study early.

United States56 participantsStarted 2022-04-21

Plain-language summary

The purpose of this study is to prospectively determine the effects of administering proton pump inhibitors (PPIs) following pancreaticoduodenectomy on postoperative outcomes. The findings of this study will help in avoiding the widespread use of PPIs during the immediate postoperative period following pancreatic surgery.

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: * All consecutive patients who will undergo pancreaticoduodenectomy with gastric/biliary reconstruction performed as definitive management for a benign or malignant disease at Washington University/Barnes-Jewish Hospital. * At least 18 years of age. * Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: * \<18 years of age

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 — do you know why it was stopped, and does that affect what we can safely conclude about using proton pump inhibitors after a Whipple procedure?
2Since this was a Phase 2 study looking at delayed gastric emptying after pancreaticoduodenectomy, what does the current evidence actually say about whether proton pump inhibitors help with that complication, given this trial didn't complete?
3Delayed gastric emptying is one of the more common complications after a Whipple surgery — how do you currently manage that risk in your patients, and has your approach been shaped by any findings from studies like this one?
4If I end up needing a pancreaticoduodenectomy, would you use proton pump inhibitors as part of my postoperative care, and what's the basis for that decision given this trial was terminated?
5Are there other completed or ongoing studies on postoperative care after a Whipple procedure that you think are more informative than this terminated trial, and should those influence our planning?

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

Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria

Timeframe: Through 90 days after surgery

Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS)

Timeframe: Through 90 days after surgery

Trial details

NCT IDNCT05251233

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-29

Results submitted2025-03-31

View on ClinicalTrials.gov More Pancreatic Cancer trials

Plain-language summary

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.

What they're measuring

Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria

Timeframe: Through 90 days after surgery

Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS)

Timeframe: Through 90 days after surgery