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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Hydrocortisone will be given intravenously.
Participants will receive a standard pancreatic resection.
University of Illinois Cancer Center
Chicago, Illinois, United States
Incidence of postoperative pancreatic fistula (POPF)
Researchers will evaluate whether perioperative intravenous (IV) hydrocortisone reduces the incidence of postoperative pancreatic fistula (POPF) in patients undergoing partial pancreatectomy/pancreatic resection. This will be measured by clinical evaluation and drain amylase measurements per the International Study Group for Pancreatic Surgery (ISGPS) criteria.
Time frame: Until 30 days after surgery
Postoperative morbidity and perioperative complications
Researchers will evaluate the effect of perioperative IV hydrocortisone on postoperative morbidity, including overall perioperative complications measured by the Comprehensive Complication Index (CCI)
Time frame: Until 30 days after surgery
Time to initiation of adjuvant chemotherapy following pancreatectomy
Researchers will evaluate the effect of perioperative IV hydrocortisone on time to initiation of adjuvant chemotherapy following pancreatectomy as measured by the number of days between surgery and the start of adjuvant chemotherapy.
Time frame: Until two years after surgery
Overall survival To evaluate overall survival (OS) following pancreatectomy between the hydrocortisone and standard-of-care (SOC) arms
Researchers will evaluate overall survival (OS) following pancreatectomy between the hydrocortisone and standard-of-case (SOC) arms measured by the amount of people alive by the end of the follow-up period.
Time frame: Until two years after surgery
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