Role Of Proton Pump Inhibitors On The Postoperative Course Following Pancreaticoduodenectomy

Study Overview

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.

N/A

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

DRUG: Placebo
DRUG: Pantoprazole

202201171

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-02-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-07-02
First Submitted that Met QC Criteria 2022-02-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-07-03
First Posted (ACTUAL) 2022-02-22	Results First Posted N/A	Last Verified 2024-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Triple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
PLACEBO_COMPARATOR: Placebo -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 Placebo capsules contain pharmaceutical-grade lactose monohydrate NF, a naturally occurring disaccharide of galactose bound to glucose.
ACTIVE_COMPARATOR: Proton pump inhibitor -Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).	DRUG: Pantoprazole The study will use commercial supply.

Participant Group/Arm

Intervention/Treatment

PLACEBO_COMPARATOR: Placebo

-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

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

ACTIVE_COMPARATOR: Proton pump inhibitor

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

DRUG: Pantoprazole

The study will use commercial supply.

Primary Outcome Measures	Measure Description	Time Frame
Incidence of 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
Incidence of delayed gastric emptying as measured by Modified Accordion Grading System (MAGS)	-Will be coded as yes and no	Through 90 days after surgery

Secondary Outcome Measures	Measure Description	Time Frame
Incidence of surgical complication defined by the Modified Accordion Grading System (MAGS)	Surgical complication is defined by the modified accordion grading system, coded as yes and no.	Through 90 days after surgery
Marginal ulcer-free survival (MUFS)	-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.	Through 90 days after surgery

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

<18 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Natash Leigh, M.D., Washington University School of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record