Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy

Sponsor

Washington University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT05251233

Collaborator

(none)

240

Enrollment

Location

Arms

39.3

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Pancreas Cancer Ampullary Cancer Pancreas Neuroendocrine Tumor Pancreatitis Distal Extrahepatic Cholangiocarcinoma Duodenal Cancer	Drug: Placebo Drug: Pantoprazole	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

Evaluation of the Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy

Actual Study Start Date :

Apr 21, 2022

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of 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
Incidence of delayed gastric emptying as measured by Modified Accordion Grading System (MAGS) [Through 90 days after surgery]
-Will be coded as yes and no

Secondary Outcome Measures

Incidence of surgical complication 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.
Marginal ulcer-free survival (MUFS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.