A Study of Methylprednisolone in People Having Liver Surgery

March 27, 2026 updated by: Memorial Sloan Kettering Cancer Center

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in 30-day all-cause morbidity between Cohort 1 and Cohort 2
Time Frame: 30 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael D'Angelica, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 27, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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