A Phase 1 interventional study of Hydrocortisone and Pancreatic resection in Pancreatic Cancer, Pancreatic Adenocarcinoma and Duodenal Cancer, sponsored by University of Illinois at Chicago. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by University of Illinois at Chicago · Phase 1, Interventional, and Treatment
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.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's planned enrollment of 20 is below the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →University of Illinois at Chicago is the lead sponsor of 506 studies on the registry; 120 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Hydrocortisone · Procedure: Pancreatic resection
Participants will receive no perioperative steroids beyond routine clinical management in addition to pancreatic resection.
Procedure: Pancreatic resection
Hydrocortisone will be given intravenously.
Participants will receive a standard pancreatic resection.
Incidence of postoperative pancreatic fistula (POPF)
Researchers will evaluate whether perioperative intravenous (IV) hydrocortisone reduces the incidence of postoperative pancreatic fistula (POPF) in patients undergoing partial pancreatectomy/pancreatic resection. This will be measured by clinical evaluation and drain amylase measurements per the International Study Group for Pancreatic Surgery (ISGPS) criteria.
Time frame: Until 30 days after surgery
Postoperative morbidity and perioperative complications
Researchers will evaluate the effect of perioperative IV hydrocortisone on postoperative morbidity, including overall perioperative complications measured by the Comprehensive Complication Index (CCI)
Time frame: Until 30 days after surgery
Time to initiation of adjuvant chemotherapy following pancreatectomy
Researchers will evaluate the effect of perioperative IV hydrocortisone on time to initiation of adjuvant chemotherapy following pancreatectomy as measured by the number of days between surgery and the start of adjuvant chemotherapy.
Time frame: Until two years after surgery
Overall survival To evaluate overall survival (OS) following pancreatectomy between the hydrocortisone and standard-of-care (SOC) arms
Researchers will evaluate overall survival (OS) following pancreatectomy between the hydrocortisone and standard-of-case (SOC) arms measured by the amount of people alive by the end of the follow-up period.
Time frame: Until two years after surgery
Start is estimated for Sep 2026; primary completion for Oct 2028, 25 months later.
Of 208 non-industry phase 1 interventional studies under Pancreatic Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 74. This study's planned 25 months is below that.
Counting every sponsor, half of 379 studies reached it within 45 months; a quarter within 32 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydrocortisone
University of Illinois at Chicago →