A Study of Methylprednisolone in People Having Liver Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatectomy
• Intervention / Treatment: Drug: Methylprednisolone

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Michael D'Angelica, MD; Phone Number: 212-639-3226; Email: dangelim@MSKCC.ORG
• Study Contact Backup: Name: Peter Kingham, MD; Phone Number: 212-639-5260; Email: kinghamP@mskcc.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Not yet recruiting
      • University of Chicago (Data Collection Only)
      • Contact: Ryan Merkow, MD; Phone Number: 773-702-1470
    • Chicago, Illinois, United States, 606012
      • Not yet recruiting
      • Rush University Medical Center (Data collection only)
      • Contact: Matt Dixon, MD; Phone Number: 312-738-3732
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Not yet recruiting
      • Indiana University (Data Collection Only)
      • Contact: Ryan Ellis, MD; Phone Number: 317-944-0920
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Not yet recruiting
      • UNIVERSITY OF IOWA (Data Collection Only)
      • Contact: Carlos Chan, MD; Phone Number: 319-356-1727
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0093
      • Not yet recruiting
      • University of Kentucky (Data Collection Only)
      • Contact: Michael Cavnar, PhD; Phone Number: 859-257-9612
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Not yet recruiting
      • Henry Ford Hospital (Data collection only)
      • Contact: Jessica DeRosier, MD; Phone Number: 517-205-1594
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Not yet recruiting
      • Mayo Clinic (Data Collection Only)
      • Contact: Cornelius Thiels, MD; Phone Number: 507-284-2511
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Not yet recruiting
      • Washington University (Data Collection Only)
      • Contact: Dominic Sanford, MD; Phone Number: 314-362-2538
  • Nebraska
    • Omaha, Nebraska, United States, 68198-7680
      • Not yet recruiting
      • University of Nebraska Medical Center (Data Collection Only)
      • Contact: Bradley Reames, MD; Phone Number: 402-559-5600
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Not yet recruiting
      • Rutgers University (Data Collection Only)
      • Contact: Miral Grandhi, MD; Phone Number: 732-235-6780
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Commack (Data Collection Only)
      • Contact: Michael D'Angelica, MD; Phone Number: 212-639-3226
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memoral Sloan Kettering Westchester (Data Collection Only)
      • Contact: Michael D'Angelica, MD; Phone Number: 212-639-3226
    • Manhasset, New York, United States, 11030
      • Not yet recruiting
      • Northwell Health (Data collection only)
      • Contact: Sepideh Gholami, MD; Phone Number: 516-734-8973
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Michael D'Angelica, MD; Phone Number: 212-639-3226
    • New York, New York, United States, 10010
      • Not yet recruiting
      • New York University (Data Collection Only)
      • Contact: Brian Kaplan, MD; Phone Number: 646-501-4848
    • Syracuse, New York, United States, 13210
      • Not yet recruiting
      • SUNY Upstate Medical University
      • Contact: Emily Allen; Phone Number: 315-464-5540
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Not yet recruiting
      • Duke University (Data Collection Only)
      • Contact: Michael Lidsky, MD; Phone Number: 919-613-1474
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Not yet recruiting
      • Gundersen Lutheran Medical Foundation (Data Collection Only)
      • Contact: Travis Smith, MD; Phone Number: 608-775-2331
    • Madison, Wisconsin, United States, 53792
      • Not yet recruiting
      • University of Wisconsin (Data Collection Only)
      • Contact: Daniel Abbott, MD; Phone Number: 608-263-0786

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Methylprednisolone	Drug: Methylprednisolone; single preoperative dose of methylprednisolone
No Intervention: Cohort 2: No Steroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Michael D'Angelica, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2026
• Primary Completion (Estimated): March 27, 2029
• Study Completion (Estimated): March 27, 2029

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; Methylprednisolone; Hepatectomy; 26-077
• Additional Relevant MeSH Terms: Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Prednisolone; Methylprednisolone
• Other Study ID Numbers: 26-077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: • 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No