Pancreatic CancerPhase 1NCT07796997
GI-06: The Impact of Perioperative Hydrocortisone on Patients Undergoing Partial Pancreatectomy
A Phase 1 study testing Hydrocortisone and Pancreatic resection in people with Pancreatic Cancer and Pancreatic Adenocarcinoma, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Adenocarcinoma, Duodenal Cancer
- What is being tested?
- Hydrocortisone and Pancreatic resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Illinois Cancer Center
Chicago, Illinois, 60612
About this study
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.
- Being tested
- Hydrocortisone, Pancreatic resection
- Medical subject headings
- Pancreatic Neoplasms, Duodenal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Hydrocortisone will be given intravenously.
Pancreatic resectionProcedure or surgery
Participants will receive a standard pancreatic resection.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative hydrocortisone and pancreatic resection | Experimental | 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). Receives: Drug: Hydrocortisone; Procedure: Pancreatic resection |
| Standard perioperative care and pancreatic resection | Active comparator | Participants will receive no perioperative steroids beyond routine clinical management in addition to pancreatic resection. Receives: Procedure: Pancreatic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until 30 days after surgery
Secondary outcomes (3)
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)
Measured: 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.
Measured: 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.
Measured: Until two years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslam Ejaz, University of Illinois Chicago
- Investigators
- Aslam Ejaz, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796997
- Sponsor's protocol ID
- 2026-0655
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GI-06: The Impact of Perioperative Hydrocortisone on Patients Undergoing Partial Pancreatectomy
- ClinicalTrials.gov ID
- NCT07796997
- Acronym / sponsor ID
- 2026-0655
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perioperative hydrocortisone and pancreatic resection | Experimental | Drug: Hydrocortisone, Procedure: Pancreatic resectionParticipants 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). |
| Standard perioperative care and pancreatic resection | Active comparator | Procedure: Pancreatic resectionParticipants will receive no perioperative steroids beyond routine clinical management in addition to pancreatic resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisoneHydrocortisone will be given intravenously. | Drug | Perioperative hydrocortisone and pancreatic resection |
| Pancreatic resectionParticipants will receive a standard pancreatic resection. | Procedure or surgery | Perioperative hydrocortisone and pancreatic resection, Standard perioperative care and pancreatic resection |
Primary outcome
Incidence of postoperative pancreatic fistula (POPF)
Time frame: Until 30 days after surgery
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.
3 secondary outcomes
Postoperative morbidity and perioperative complications
Time frame: Until 30 days after surgery
Time to initiation of adjuvant chemotherapy following pancreatectomy
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
Time frame: Until two years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aslam Ejaz, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydrocortisone and Pancreatic resection in people with Pancreatic Cancer and Pancreatic Adenocarcinoma, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aslam Ejaz, MD ((312) 996-6666, aejaz@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative pancreatic fistula (POPF) (time frame: Until 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.