GI-06: The Impact of Perioperative Hydrocortisone on Patients Undergoing Partial Pancreatectomy

Part of paid clinical trials in Chicago, Illinois.

Sponsor: University of Illinois at Chicago
Study ID: NCT07796997
Phase: PHASE1
Status: Not Yet Recruiting

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Conditions

Distal Cholangiocarcinoma
Duodenal Cancer
Pancreatic Adenocarcinoma
Pancreatic Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Hydrocortisone — DRUG
Hydrocortisone will be given intravenously.
Pancreatic resection — PROCEDURE
Participants will receive a standard pancreatic resection.

Study Details

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.

Key Dates

First listed: Sep 1, 2026
Start date: Sep 30, 2026
Status verified: Aug 2026
Primary completion: Oct 31, 2028
Completion: Sep 30, 2030

Study Design

Enrollment: 20 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Perioperative hydrocortisone and pancreatic resection
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).
Active Comparator: Standard perioperative care and pancreatic resection
Participants will receive no perioperative steroids beyond routine clinical management in addition to pancreatic resection.