Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy

NCT05251233 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 202201171
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Pancreas Cancer; Ampullary Cancer; Pancreas Neuroendocrine Tumor; Pancreatitis; Distal Extrahepatic Cholangiocarcinoma; Duodenal Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Through 90 days after surgery

Secondary Outcomes (2)

• Number of Participants With Surgical Complication(s) Defined by the Modified Accordion Grading System (MAGS)

  Through 90 days after surgery

• Kaplan-Meier Estimated 90-days Marginal Ulcer-free Survival (MUFS) Probability

  Through 90 days after surgery

Study Arms (2)

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).

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).

Drug: Pantoprazole

Interventions

Placebo DRUG

Placebo capsules contain pharmaceutical-grade lactose monohydrate NF, a naturally occurring disaccharide of galactose bound to glucose.

Placebo

Pantoprazole DRUG

The study will use commercial supply.

Proton pump inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<18 years of age

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatitis; Duodenal Neoplasms

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Natasha Leigh-Matijakovich, M.D.
• Organization: Washington University School of Medicine

leigh@wustl.edu

314-362-7147

Study Officials

• Natasha Leigh-Matijakovich, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 22, 2022
• Study Start: April 21, 2022
• Primary Completion: June 29, 2024
• Study Completion: June 29, 2024
• Last Updated: May 6, 2025
• Results First Posted: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)