This phase II trial tests the impact of proton pump inhibitors on postoperative complications following pancreaticoduodenectomy. Patients who have undergone pancreaticoduodenectomy, Whipple procedure, are often prescribed a kind of drug called a proton pump inhibitor (PPI) to help prevent stress ulcers and bleeding in the upper digestive tract. Proton pump inhibitors (in this study pantoprazole) help prevent stress ulcers and bleeding in the upper digestive tract. This study may help researchers understand more about the use of PPIs after pancreatic surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05251233.
PRIMARY OBJECTIVE:
I. Determine the effect of proton pump inhibitors (PPIs) on the incidence of delayed gastric emptying within 90 days in patients after pancreaticoduodenectomy.
SECONDARY OBJECTIVES:
I. Determine the effect of PPIs on the incidence of overall postoperative complications in the patients after pancreaticoduodenectomy.
II. Determine the marginal ulcer-free survival (MUFS) within 90 days in the patients undergoing pancreaticoduodenectomy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive pantoprazole sodium orally (PO) once daily (QD) for up to 10 days (postoperative days 1-10), or until day of discharge, whichever is earlier.
ARM II: Patients receive placebo PO QD starting on postoperative for up to 10 days (postoperative days 1-10), or until day of discharge, whichever is earlier.
After completion of study treatment, patients are followed up for 90 days post-operative.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorNatasha Leigh
