Hydrocortisone for Pancreatic Cancer

AE
HD
Overseen ByHilda Diaz, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Illinois at Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AE

Aslam Ejaz, MD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for adults scheduled to have part of their pancreas removed due to pancreatic, duodenal, or bile duct cancer. Participants must be able to safely receive surgery and follow study procedures.

Inclusion Criteria

I am 18 years old or older.
My surgeon has confirmed I am fit for surgery after reviewing my tests.
I am able to give written consent or have a legal representative do so for me.
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Exclusion Criteria

I do not have any condition that stops me from understanding or joining the trial.
I have adrenal insufficiency and need ongoing steroid treatment.
Pregnant or nursing
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What Are the Treatments Tested in This Trial?

Interventions

  • Hydrocortisone

Trial Overview

The study compares giving hydrocortisone (a steroid) around the time of surgery versus standard care without extra steroids in patients having partial pancreatectomy. Patients are randomly assigned to one group or the other.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Perioperative hydrocortisone and pancreatic resectionExperimental Treatment2 Interventions
Group II: Standard perioperative care and pancreatic resectionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+