GI-06: The Impact of Perioperative Hydrocortisone on Patients Undergoing Partial Pancreatectomy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Hydrocortisone
DrugHydrocortisone will be given intravenously.
Pancreatic resection
Procedure/SurgeryParticipants will receive a standard pancreatic resection.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Perioperative hydrocortisone and pancreatic resectionExperimental treatment 2 interventions
Group B: Standard perioperative care and pancreatic resectionActive comparator 1 intervention
Trial outcomes
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.
Time frame
Until 30 days after surgerySecondary outcomes
1
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 surgery2
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 surgery3
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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: