Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy

Phase 2

Terminated

• Conditions: Ampullary Cancer; Pancreas Neuroendocrine Tumor; Pancreatitis; Pancreatic Cancer; Distal Extrahepatic Cholangiocarcinoma; Pancreas Cancer; Duodenal Cancer
• Interventions: Drug: Placebo; Drug: Pantoprazole

• Registration Number: NCT05251233
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-11
• Study First Posted: 2022-02-22
• Study Start: 2022-04-21
• Primary Completion: 2024-06-29
• Study Completion: 2024-06-29
• Results First Submitted: 2025-03-31
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-18
• Last Update Submitted: 2025-04-18
• Results First Posted: 2025-05-06
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS)	Through 90 days after surgery	-Will be coded as yes and no
Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria	Through 90 days after surgery	-Will be coded as yes and no

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Surgical Complication(s) Defined by the Modified Accordion Grading System (MAGS)	Through 90 days after surgery	Surgical complication is defined by the Modified Accordion Grading System, coded as yes and no.
Kaplan-Meier Estimated 90-days Marginal Ulcer-free Survival (MUFS) Probability	Through 90 days after surgery	-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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States