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One-Dose steroid before liver surgery may cut infections and hospital time

NCT ID NCT07507643

Symptom relief Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether a single dose of methylprednisolone given before major liver surgery can lower the risk of complications like infections and shorten hospital stays. About 750 adults scheduled for major hepatectomy will be randomly assigned to receive either the steroid or standard care. The study aims to see if this simple addition improves recovery without causing harm.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methylprednisolone
What this could lead to
If it works, this could lead to fewer infections and shorter hospital stays for patients undergoing major liver surgery.
What could go wrong
This is a single preoperative dose, not a cure. The benefit may be small, and some patients may have adverse reactions to the drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 750 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatectomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University (Data Collection Only)

    NOT_YET_RECRUITING

    Durham, North Carolina, 27710, United States

  • Gundersen Lutheran Medical Foundation (Data Collection Only)

    NOT_YET_RECRUITING

    La Crosse, Wisconsin, 54601, United States

  • Henry Ford Hospital (Data collection only)

    NOT_YET_RECRUITING

    Detroit, Michigan, 48202, United States

  • Indiana University (Data Collection Only)

    NOT_YET_RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Mayo Clinic (Data Collection Only)

    NOT_YET_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memoral Sloan Kettering Westchester (Data Collection Only)

    RECRUITING

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack (Data Collection Only)

    RECRUITING

    Commack, New York, 11725, United States

  • New York University (Data Collection Only)

    NOT_YET_RECRUITING

    New York, New York, 10010, United States

  • Northwell Health (Data collection only)

    NOT_YET_RECRUITING

    Manhasset, New York, 11030, United States

  • Rush University Medical Center (Data collection only)

    NOT_YET_RECRUITING

    Chicago, Illinois, 606012, United States

  • Rutgers University (Data Collection Only)

    NOT_YET_RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • SUNY Upstate Medical University

    NOT_YET_RECRUITING

    Syracuse, New York, 13210, United States

  • UNIVERSITY OF IOWA (Data Collection Only)

    NOT_YET_RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Chicago (Data Collection Only)

    NOT_YET_RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Kentucky (Data Collection Only)

    NOT_YET_RECRUITING

    Lexington, Kentucky, 40536-0093, United States

  • University of Nebraska Medical Center (Data Collection Only)

    NOT_YET_RECRUITING

    Omaha, Nebraska, 68198-7680, United States

  • University of Wisconsin (Data Collection Only)

    NOT_YET_RECRUITING

    Madison, Wisconsin, 53792, United States

  • Washington University (Data Collection Only)

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

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