Pancreatic Cancer Clinical Trial
Official title:
Evaluation of the Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
Verified date | April 2024 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
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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