Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy

The Washington University

Status and phase: Terminated; Phase 2

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

Treatments: Drug: Placebo; Drug: Pantoprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT05251233

202201171

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Exclusion criteria

• <18 years of age

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Proton pump inhibitor

Active Comparator group

Description:

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

Treatment:

Drug: Pantoprazole