Pancreatic CancerPhase 2NCT05251233
Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
A Phase 2 study testing Pantoprazole in people with Pancreatic Cancer and Pancreas Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreas Cancer, Ampullary Cancer
- What is being tested?
- Pantoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to 29 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- <18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Evaluation of the Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
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.
- Conditions
- Pancreatic Cancer, Pancreas Cancer, Ampullary Cancer, Pancreas Neuroendocrine Tumor, Pancreatitis, Distal Extrahepatic Cholangiocarcinoma
- Being tested
- Placebo, Pantoprazole
- Medical subject headings
- Pancreatic Neoplasms, Pancreatitis, Duodenal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo capsules contain pharmaceutical-grade lactose monohydrate NF, a naturally occurring disaccharide of galactose bound to glucose.
PantoprazoleDrug
The study will use commercial supply.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | -Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). Receives: Drug: Placebo |
| Proton pump inhibitor | Active comparator | -Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). Receives: Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria
-Will be coded as yes and no
Measured: Through 90 days after surgery
Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS)
-Will be coded as yes and no
Measured: Through 90 days after surgery
Secondary outcomes (2)
Number of Participants With Surgical Complication(s) Defined by the Modified Accordion Grading System (MAGS)
Surgical complication is defined by the Modified Accordion Grading System, coded as yes and no.
Measured: Through 90 days after surgery
Kaplan-Meier Estimated 90-days Marginal Ulcer-free Survival (MUFS) Probability
-MUFS is defined as the days from the date of randomization to diagnosis of a marginal ulcer. The patients without marginal ulcer are censored at the date of last follow-up.
Measured: Through 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start21 Apr 2022
- Primary completion29 Jun 2024
- Study completion29 Jun 2024
Why it stopped: Investigator and study team chose to end study early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natasha Leigh-Matijakovich, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251233
- Sponsor's protocol ID
- 202201171
- Status last verified
- Apr 2025
- First submitted
- 11 Feb 2022
- Last updated
- 6 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT05251233
- Acronym / sponsor ID
- 202201171
- Conditions
- Pancreatic Cancer, Pancreas Cancer, Ampullary Cancer, Pancreas Neuroendocrine Tumor, Pancreatitis, Distal Extrahepatic Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator and study team chose to end study early.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 29 Jun 2024 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo-Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). |
| Proton pump inhibitor | Active comparator | Drug: Pantoprazole-Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- <18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo capsules contain pharmaceutical-grade lactose monohydrate NF, a naturally occurring disaccharide of galactose bound to glucose. | Drug | Placebo |
| PantoprazoleThe study will use commercial supply. | Drug | Proton pump inhibitor |
Primary outcome
Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria
Time frame: Through 90 days after surgery
-Will be coded as yes and no
Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS)
Time frame: Through 90 days after surgery
-Will be coded as yes and no
2 secondary outcomes
Number of Participants With Surgical Complication(s) Defined by the Modified Accordion Grading System (MAGS)
Time frame: Through 90 days after surgery
Kaplan-Meier Estimated 90-days Marginal Ulcer-free Survival (MUFS) Probability
Time frame: Through 90 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natasha Leigh-Matijakovich, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pantoprazole in people with Pancreatic Cancer and Pancreas Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria (time frame: Through 90 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.