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A Study of Methylprednisolone in People Having Liver Surgery

RecruitingPhase 3

A Randomized Controlled Trial of Methylprednisolone Versus Standard of Care in Patients Undergoing Major Hepatectomy

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

About the study

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 is being tested

Sponsor: Memorial Sloan Kettering Cancer Center · Participants: 750 · Started: Mar 27, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07507643

Locations in the U.S.

IllinoisRush University Medical Center (Data collection only), Chicago (Not yet recruiting)
University of Chicago (Data Collection Only), Chicago (Not yet recruiting)
IndianaIndiana University (Data Collection Only), Indianapolis (Not yet recruiting)
IowaUNIVERSITY OF IOWA (Data Collection Only), Iowa City (Not yet recruiting)
KentuckyUniversity of Kentucky (Data Collection Only), Lexington (Not yet recruiting)
MichiganHenry Ford Hospital (Data collection only), Detroit (Not yet recruiting)
MinnesotaMayo Clinic (Data Collection Only), Rochester (Not yet recruiting)
MissouriWashington University (Data Collection Only), St Louis (Not yet recruiting)
NebraskaUniversity of Nebraska Medical Center (Data Collection Only), Omaha (Not yet recruiting)
New JerseyRutgers University (Data Collection Only), New Brunswick (Not yet recruiting)
New YorkMemorial Sloan Kettering Commack (Data Collection Only), Commack
Memoral Sloan Kettering Westchester (Data Collection Only), Harrison
Northwell Health (Data collection only), Manhasset (Not yet recruiting)
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York
New York University (Data Collection Only), New York (Not yet recruiting)
SUNY Upstate Medical University, Syracuse (Not yet recruiting)
North CarolinaDuke University (Data Collection Only), Durham (Not yet recruiting)
WisconsinGundersen Lutheran Medical Foundation (Data Collection Only), La Crosse (Not yet recruiting)
University of Wisconsin (Data Collection Only), Madison (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.