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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
56
Placebo capsules contain pharmaceutical-grade lactose monohydrate NF, a naturally occurring disaccharide of galactose bound to glucose.
The study will use commercial supply.
Washington University School of Medicine
St Louis, Missouri, United States
Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria
-Will be coded as yes and no
Time frame: Through 90 days after surgery
Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS)
-Will be coded as yes and no
Time frame: Through 90 days after surgery
Number of Participants With Surgical Complication(s) Defined by the Modified Accordion Grading System (MAGS)
Surgical complication is defined by the Modified Accordion Grading System, coded as yes and no.
Time frame: Through 90 days after surgery
Kaplan-Meier Estimated 90-days Marginal Ulcer-free Survival (MUFS) Probability
-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.
Time frame: Through 90 days after surgery
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