Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-21

Study Completion Date

2024-06-29

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Proton pump inhibitor

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

Group Type ACTIVE_COMPARATOR

Pantoprazole

Intervention Type DRUG

The study will use commercial supply.

Interventions

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Placebo

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

Intervention Type DRUG

Pantoprazole

The study will use commercial supply.

Intervention Type DRUG

Eligibility Criteria

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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.