Clinical trialPhase 1Not yet recruiting
GI-06: The Impact of Perioperative Hydrocortisone on Patients Undergoing Partial Pancreatectomy
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Not yet recruiting
- Study type
- Interventional
- Start
- September 2026
- Expected end
- September 2030
- Enrollment
- 20 participants
- Sites
- 1
- Primary outcomes
- Incidence of postoperative pancreatic fistula (POPF)
- Sponsor
- Other
- Results posted
- No
- Last update
- 1 September 2026
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Brief summary public domain (ClinicalTrials.gov)
This is a single-site, randomized, controlled treatment trial evaluating perioperative steroid hydrocortisone use in patients undergoing pancreatic resection (partial pancreatectomy). Eligible participants will be randomized to one of two arms: (1) perioperative hydrocortisone or (2) standard perioperative care. Participants randomized to the intervention arm will receive hydrocortisone 100 mg intravenously at the time of resection, followed by two additional 100 mg intravenous doses administered every 8 hours, for a total of 3 doses over approximately 16 hours. Participants randomized to the standard of care arm will receive no perioperative steroid therapy beyond routine clinical management. Participants will be followed for postoperative outcomes, including postoperative complications and other adverse events (AEs), as well as for downstream oncologic outcomes, including time to chemotherapy initiation and overall survival. The planned study duration is 2 years with an anticipated sample size of 20 participants.