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Methylprednisolone Before Major Liver Surgery

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

Phase 3 Interventional Memorial Sloan Kettering Cancer Center · NCT07507643

This trial tests whether giving methylprednisolone before major liver surgery helps reduce postoperative complications like infections and long hospital stays for adults having hepatectomy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment750 (estimated)
Ages18 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionschemotherapy
Locations19 sites (Chicago, Illinois and 18 other locations)
Trial IDNCT07507643 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial gives methylprednisolone before elective major hepatectomy to see if it lowers postoperative complications and shortens recovery. Eligible adults are those scheduled for defined major liver resections (trisegmentectomy, total left, or total right hepatectomy) and may have additional partial resections or ablation. Key exclusions include known allergy or contraindication to methylprednisolone and recent long-term systemic corticosteroid use. The trial is led by Memorial Sloan Kettering Cancer Center with data collection at several academic centers in the Midwest.

Who should consider this trial

Good fit: Adults aged 18 or older who are scheduled for elective major hepatectomy (trisegmentectomy, total left, or total right hepatectomy), with or without additional partial hepatectomy or operative ablation, are ideal candidates.

Not a fit: Patients with known adverse reactions or contraindications to methylprednisolone, those on recent long-term systemic corticosteroids, or those not undergoing the specified major hepatectomy procedures are unlikely to benefit.

Why it matters

Potential benefit: If successful, preoperative methylprednisolone could reduce postoperative infections, shorten hospital stays, and speed recovery after major liver resection.

How similar studies have performed: Perioperative corticosteroids have been tested in other surgical settings with mixed results, and benefit specifically for major hepatectomy is not yet firmly established.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Chicago, Illinois and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HepatectomyMethylprednisoloneMemorial Sloan Kettering Cancer Center26-077
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.