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NCT07507643PHASE3Recruiting

A Study of Methylprednisolone in People Having Liver Surgery

Memorial Sloan Kettering Cancer Center

Start Date

3/27/2026

Completion Date

3/27/2029

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Methylprednisolone

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Conditions

Hepatectomy

Locations

Rush University Medical Center (Data collection only)

Chicago, Illinois 606012

United States

University of Chicago (Data Collection Only)

Chicago, Illinois 60637

United States

Indiana University (Data Collection Only)

Indianapolis, Indiana 46202

United States

UNIVERSITY OF IOWA (Data Collection Only)

Iowa City, Iowa 52242

United States

University of Kentucky (Data Collection Only)

Lexington, Kentucky 40536-0093

United States

Henry Ford Hospital (Data collection only)

Detroit, Michigan 48202

United States

Mayo Clinic (Data Collection Only)

Rochester, Minnesota 55905

United States

Washington University (Data Collection Only)

St Louis, Missouri 63110

United States

University of Nebraska Medical Center (Data Collection Only)

Omaha, Nebraska 68198-7680

United States

Rutgers University (Data Collection Only)

New Brunswick, New Jersey 08903

United States

Memorial Sloan Kettering Commack (Data Collection Only)

Commack, New York 11725

United States

Memoral Sloan Kettering Westchester (Data Collection Only)

Harrison, New York 10604

United States

Northwell Health (Data collection only)

Manhasset, New York 11030

United States

New York University (Data Collection Only)

New York, New York 10010

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York 10065

United States

SUNY Upstate Medical University

Syracuse, New York 13210

United States

Duke University (Data Collection Only)

Durham, North Carolina 27710

United States

Gundersen Lutheran Medical Foundation (Data Collection Only)

La Crosse, Wisconsin 54601

United States

University of Wisconsin (Data Collection Only)

Madison, Wisconsin 53792

United States