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NCT05251233 Clinical Trial

Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05251233
Other study ID # 202201171
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date April 21, 2022
Est. completion date June 30, 2024

Study information
Verified date April 2024
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 56
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo capsules contain pharmaceutical-grade lactose monohydrate NF, a naturally occurring disaccharide of galactose bound to glucose.
• Pantoprazole
The study will use commercial supply.

Locations
Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
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