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

NCT07796997 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-09-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Hydrocortisone

Hydrocortisone will be given intravenously.

PROCEDURE

Pancreatic resection

Participants will receive a standard pancreatic resection.

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Aslam Ejaz, MD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-10-31
Completion
2030-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07796997 on ClinicalTrials.gov