What this study is
The purpose of this study is to test whether receiving methylprednisolone before surgery will reduce the side effects of having surgery, such as infections and longer hospital stays.
What's being tested
- Methylprednisolone
Intervention · DRUG
single preoperative dose of methylprednisolone
Study details
- Official title
- A Randomized Controlled Trial of Methylprednisolone Versus Standard of Care in Patients Undergoing Major Hepatectomy
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Hepatectomy
- Enrolling
- 750 people
- Starts
- 2026-03-27
- Est. completion
- 2029-03-27
- Design
- Open-label, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age ≥18 years at the time of consent.
- Scheduled to undergo elective major hepatectomy (defined by CPT codes 47122 [trisegmentectomy], 47125 [total left hepatectomy], or 47130 [total right hepatectomy]).
- In addition to major hepatectomy, as defined above, patients may undergo additional partial hepatectomy or operative ablation.
You can't join if
- Known or documented adverse reactions to methylprednisolone.
- Unable to receive methylprednisolone because of coexisting medical conditions.
- Long-term (≥10-day course) systemic corticosteroid use, regardless of dose, if doses have been administered within 30 days of the planned date of surgery. This will not apply to steroids administered, in accordance with the standard of care, with preoperative chemotherapy. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive-airway diseases), eye drops, and local injections (e.g., intra-articular).
- Significant chance (based on surgeon judgement) of being unable to successfully complete surgery because of unresectability.
- Expected or highly likely to undergo concomitant major organ resection (stomach, pancreas, colon, rectum, uterus, ovaries, bladder, kidney, small bowel).
- Expected or highly likely to undergo biliary tree reconstruction via creation of a biliary-enteric anastomosis.
- Scheduled to undergo concurrent insertion of a hepatic artery infusion pump device.
- Estimated renal dysfunction defined by any of the following: creatinine clearance ≤40 mL/min as calculated by the Cockcroft-Gault Equation, currently on hemodialysis, currently on peritoneal dialysis.
- Dependence on mechanical ventilation before surgery.
- Pregnant or nursing (lactating), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- Known at the time of enrollment to have a bacterial infection that is expected to be present at the time of surgery or receipt of systemic antibiotic or antifungal therapy within 7 days before surgery.
- Unable to provide informed consent
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (19)
19 openRush University Medical Center (Data collection only)
Chicago, Illinois, United States
- Matt Dixon, MD · Contact312-738-3732
Not yet recruitingUniversity of Chicago (Data Collection Only)
Chicago, Illinois, United States
- Ryan Merkow, MD · Contact773-702-1470
Not yet recruitingIndiana University (Data Collection Only)
Indianapolis, Indiana, United States
- Ryan Ellis, MD · Contact317-944-0920
Not yet recruitingUNIVERSITY OF IOWA (Data Collection Only)
Iowa City, Iowa, United States
- Carlos Chan, MD · Contact319-356-1727
Not yet recruitingUniversity of Kentucky (Data Collection Only)
Lexington, Kentucky, United States
- Michael Cavnar, PhD · Contact859-257-9612
Not yet recruitingHenry Ford Hospital (Data collection only)
Detroit, Michigan, United States
- Jessica DeRosier, MD · Contact517-205-1594
Not yet recruitingMayo Clinic (Data Collection Only)
Rochester, Minnesota, United States
- Cornelius Thiels, MD · Contact507-284-2511
Not yet recruitingWashington University (Data Collection Only)
St Louis, Missouri, United States
- Dominic Sanford, MD · Contact314-362-2538
Not yet recruitingUniversity of Nebraska Medical Center (Data Collection Only)
Omaha, Nebraska, United States
- Bradley Reames, MD · Contact402-559-5600
Not yet recruitingRutgers University (Data Collection Only)
New Brunswick, New Jersey, United States
- Miral Grandhi, MD · Contact732-235-6780
Not yet recruitingMemorial Sloan Kettering Commack (Data Collection Only)
Commack, New York, United States
- Michael D'Angelica, MD · Contact212-639-3226
RecruitingMemoral Sloan Kettering Westchester (Data Collection Only)
Harrison, New York, United States
- Michael D'Angelica, MD · Contact212-639-3226
RecruitingNorthwell Health (Data collection only)
Manhasset, New York, United States
- Sepideh Gholami, MD · Contact516-734-8973
Not yet recruitingNew York University (Data Collection Only)
New York, New York, United States
- Brian Kaplan, MD · Contact646-501-4848
Not yet recruitingMemorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
- Michael D'Angelica, MD · Contact212-639-3226
Recruiting- Not yet recruiting
Duke University (Data Collection Only)
Durham, North Carolina, United States
- Michael Lidsky, MD · Contact919-613-1474
Not yet recruitingGundersen Lutheran Medical Foundation (Data Collection Only)
La Crosse, Wisconsin, United States
- Travis Smith, MD · Contact608-775-2331
Not yet recruitingUniversity of Wisconsin (Data Collection Only)
Madison, Wisconsin, United States
- Daniel Abbott, MD · Contact608-263-0786
Not yet recruiting
Study team
Sponsor
Memorial Sloan Kettering Cancer Center
Study ID 26-077
Principal investigator
Michael D'Angelica, MD
Memorial Sloan Kettering Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.