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Proton Pump Inhibitor

Pantoprazole for Pancreatic Surgery Recovery

Phase 2

Recruiting

Led By Natash Leigh, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 90 days after surgery

Awards & highlights

Study Summary

This trial will help determine if proton pump inhibitors (PPIs), commonly used after pancreatic surgery, are actually effective in improving postoperative outcomes.

Who is the study for?

This trial is for adults who are undergoing pancreaticoduodenectomy with gastric/biliary reconstruction at Washington University/Barnes-Jewish Hospital. It's aimed at patients treated for various pancreatic and duodenal diseases, including cancers and pancreatitis. Participants must understand and sign a consent form.Check my eligibility

What is being tested?

The study is testing the effects of proton pump inhibitors (PPIs), specifically Pantoprazole, on recovery after pancreatic surgery compared to a placebo. The goal is to see if PPIs influence postoperative outcomes and whether their use should be limited following surgery.See study design

What are the potential side effects?

While not specified here, common side effects of PPIs like Pantoprazole may include headaches, diarrhea, nausea, abdominal pain, constipation or dizziness. Serious side effects can occur but are less common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a surgery at Washington University/Barnes-Jewish Hospital to treat a pancreatic or duodenal condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 90 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 90 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 90 days after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of delayed gastric emptying as measured by Modified Accordion Grading System (MAGS)

Incidence of delayed gastric emptying as measured by the International Study Group of Pancreatic Surgery (ISGPS) criteria

Secondary outcome measures

Incidence of surgical complication defined by the Modified Accordion Grading System (MAGS)

Marginal ulcer-free survival (MUFS)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Proton pump inhibitorActive Control1 Intervention

-Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).

Group II: PlaceboPlacebo Group1 Intervention

-Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,563 Total Patients Enrolled

Natash Leigh, M.D.Principal InvestigatorWashington University School of Medicine

Chet Hammill, M.D., MCR, FACSPrincipal InvestigatorWashington University School of Medicine

1 Previous Clinical Trials

169 Total Patients Enrolled

Media Library

Pantoprazole (Proton Pump Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05251233 — Phase 2

Pancreatic Cancer Research Study Groups: Proton pump inhibitor, Placebo

Pancreatic Cancer Clinical Trial 2023: Pantoprazole Highlights & Side Effects. Trial Name: NCT05251233 — Phase 2

Pantoprazole (Proton Pump Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05251233 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any harmful side effects of Proton pump inhibitor use?

"Proton pump inhibitor received a 2 because, while there is data suggesting it is safe, there is no evidence yet that it is an effective treatment."

Answered by AI

Are there any open positions for patients in this clinical trial?

"That is correct, the trial information on clinicaltrials.gov does say that the study is looking for more participants. The first posting was on 4/21/2022 and there have been no updates since then. They are hoping to enroll a total of 240 patients from 1 site."

Answered by AI

How many people are participating in this testing phase of the treatment?

"That is correct, the online information regarding this clinical trial indicates that it is currently looking for patients. The trial was first posted on 4/21/2022 and was last edited on the same date. Up to 240 people are needed for the study which will take place at 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy

2022. "Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05251233.

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