GI-06: The Impact of Perioperative Hydrocortisone on Patients Undergoing Partial Pancreatectomy

NCT07796997 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2026-0655
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pancreatic Cancer; Pancreatic Adenocarcinoma; Duodenal Cancer; Distal Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Until 30 days after surgery

Secondary Outcomes (3)

• Postoperative morbidity and perioperative complications

  Until 30 days after surgery

• Time to initiation of adjuvant chemotherapy following pancreatectomy

  Until two years after surgery

• Overall survival To evaluate overall survival (OS) following pancreatectomy between the hydrocortisone and standard-of-care (SOC) arms

  Until two years after surgery

Study Arms (2)

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).

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.

Procedure: Pancreatic resection

Interventions

Hydrocortisone DRUG

Hydrocortisone will be given intravenously.

Perioperative hydrocortisone and pancreatic resection

Pancreatic resection PROCEDURE

Participants will receive a standard pancreatic resection.

Perioperative hydrocortisone and pancreatic resection; Standard perioperative care and pancreatic resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Duodenal Neoplasms

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Aslam Ejaz, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aslam Ejaz, MD

CONTACT

(312) 996-6666; aejaz@uic.edu

Hilda Diaz, MPH

CONTACT

(312) 996-6416; hdiaz@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 1, 2026

Record last verified: 2026-08

Locations

US (1)