NCT07796997
GI-06: The Impact of Perioperative Hydrocortisone on Patients Undergoing Partial Pancreatectomy
StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History
All 1 version: 1 with changes below.
- Study First Submitted
Endpoints
Primary
Incidence of postoperative pancreatic fistula (POPF)
Timeframe: Until 30 days after surgery
Secondary (3)
Postoperative morbidity and perioperative complications
Time to initiation of adjuvant chemotherapy following pancreatectomy
Overall survival To evaluate overall survival (OS) following pancreatectomy between the hydrocortisone and standard-of-care (SOC) arms
Arms and interventions
Perioperative hydrocortisone and pancreatic resectionExperimental
Participants will receive hydrocortisone 100 mg intravenously (IV) at the time of pancreatic resection, followed by two additional 100 mg IV doses administered every 8 hours (three doses total).
Standard perioperative care and pancreatic resectionActive comparator
Participants will receive no perioperative steroids beyond routine clinical management in addition to pancreatic resection.
Drugs: Hydrocortisone
Procedures: Pancreatic resection
Sites
1 site in 1 country
- University of Illinois Cancer CenterChicago, Illinois, United States