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Proton Pump Inhibitor
Pantoprazole for Pancreatic Surgery Recovery
Phase 2
Waitlist Available
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 belowSelect...
I am 18 years old or older.
Select...
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
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).
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,945 Previous Clinical Trials
2,303,764 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I am 18 years old or older.I am scheduled for a surgery at Washington University/Barnes-Jewish Hospital to treat a pancreatic or duodenal condition.
Research Study Groups:
This trial has the following groups:- Group 1: Proton pump inhibitor
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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