Can a steroid given during pancreatic surgery prevent a dangerous leak?

NCT ID NCT07796997

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether giving hydrocortisone during and right after pancreatic surgery can lower the risk of a postoperative pancreatic fistula, a serious leak of digestive fluids. About 20 adults with pancreatic, duodenal, or bile duct cancer will be randomly assigned to receive either hydrocortisone or standard care. Researchers will track complications, how quickly patients can start chemotherapy, and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hydrocortisone given intravenously during surgery
What this could lead to
If it works, this could reduce serious complications after pancreatic surgery and help patients start chemotherapy sooner, potentially improving long-term outcomes.
What could go wrong
This is a small early-phase trial with only 20 participants, so results may not apply broadly. Hydrocortisone can have side effects, and the benefit is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years of age at time of consent * Eastern Cooperative Oncology Group (ECOG) 0-2 * Histologically confirmed pancreatic adenocarcinoma, ampullary adenocarcinoma, duodenal cancer, or distal cholangiocarcinoma, documented by biopsy. Patients with suspected distal cholangiocarcinoma who are unable to achieve histologic confirmation prior to surgery will also be included. * Planned to undergo pancreatic head resection (pancreaticoduodenectomy), as determined by the treating surgical team. * Planned to undergo pancreatic resection with curative or therapeutic intent, as determined by the treating surgical team. * Deemed appropriate for surgery based on the treating surgeon's comprehensive preoperative clinical assessment, including review of SOC laboratory studies. * Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC-IRB ICF HIPAA authorization. If a subject is unable to consent, a legally authorized representative (LAR) may provide consent on their behalf. * Women of child-bearing potential (WOCBP) must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines. * As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study. Exclusion Criteria: * Prior pancreatic surgery. * Chronic systemic corticosteroids are used within 30 days prior to surgery (excluding topical, inhaled, or physiologic replacement doses). * Known hypersensitivity or contraindication to corticosteroids. * Active uncontrolled infection at the time of enrollment (registration). * Uncontrolled diabetes mellitus or a history of steroid-induced hyperglycemia requires hospitalization. * Known adrenal insufficiency requiring chronic steroid replacement. * Pregnant or nursing * Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist. * Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial. * Other major comorbidity, as determined by the study Principal Investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612, United States

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