A Study of Methylprednisolone in People Having Liver Surgery
A Randomized Controlled Trial of Methylprednisolone Versus Standard of Care in Patients Undergoing Major Hepatectomy
1 other identifier
interventional
750
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2026
Typical duration for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2026
CompletedStudy Start
First participant enrolled
March 27, 2026
CompletedFirst Posted
Study publicly available on registry
April 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 27, 2029
April 2, 2026
March 1, 2026
3 years
March 27, 2026
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in 30-day all-cause morbidity between Cohort 1 and Cohort 2
To determine whether the administration of preoperative methylprednisolone will result in lower 30-day all-cause morbidity, compared with the standard of care (no methylprednisolone), in participants undergoing elective major hepatectomy for all indications.
30 days
Study Arms (2)
Cohort 1: Methylprednisolone
EXPERIMENTALCohort 2: No Steroid
NO INTERVENTIONInterventions
Eligibility Criteria
You 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
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
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael D'Angelica, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2026
First Posted
April 2, 2026
Study Start
March 27, 2026
Primary Completion (Estimated)
March 27, 2029
Study Completion (Estimated)
March 27, 2029
Last Updated
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org