Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy

Study Overview
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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.

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

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

Intervention / Treatment
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* Drug: Placebo
* Drug: Pantoprazole


Participation Criteria
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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. Exclusion Criteria: <18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 |