Clinical trialPhase 2Terminated
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
- Outcome
- Stopped earlyInvestigator and study team chose to end study early. (Other)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 21 April 2022
- Expected end
- 29 June 2024
- Enrollment
- 56 participants
- Sites
- 1
- Primary outcomes
- Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria; Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS)
- Sponsor
- Other
- Results posted
- 2025-05-06
- Last update
- 6 May 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria [Through 90 days after surgery]. Count Of Participants, Participants. Placebo (n=18): 3; Proton Pump Inhibitor (n=20): 6.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS) [Through 90 days after surgery]. Count Of Participants, Participants. Placebo (n=18): 3; Proton Pump Inhibitor (n=20): 6.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Surgical Complication(s) Defined by the Modified Accordion Grading System (MAGS) [Through 90 days after surgery]. Count Of Participants, Participants. Placebo (n=18): 8; Proton Pump Inhibitor (n=20): 11.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Kaplan-Meier Estimated 90-days Marginal Ulcer-free Survival (MUFS) Probability [Through 90 days after surgery]. Number, proportion probability (95% Confidence Interval). Placebo (n=13): 0.9230769 (0.5663595 to 0.9887941); Proton Pump Inhibitor (n=16): 0.875 (0.5859814 to 0.9671888).