Can a steroid given during pancreatic surgery prevent a dangerous leak?
NCT ID NCT07796997
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Illinois Cancer Center
Chicago, Illinois, 60612, United States
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