Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy

Evaluation of the 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Cancer; Pancreatitis; Pancreas Cancer; Duodenal Cancer; Ampullary Cancer; Pancreas Neuroendocrine Tumor; Distal Extrahepatic Cholangiocarcinoma
• Intervention / Treatment: Drug: Placebo; Drug: Pantoprazole

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Natasha Leigh, M.D.; Phone Number: 314-362-7147; Email: leigh@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Natash Leigh, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Intestinal Diseases; Intestinal Neoplasms; Duodenal Diseases; Pancreatic Diseases; Pancreatic Neoplasms; Cholangiocarcinoma; Pancreatitis; Neuroendocrine Tumors; Duodenal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: 202201171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No