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NCT Number: NCT07507643

A Study of Methylprednisolone in People Having Liver Surgery

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rush University Medical Center (Data collection only), Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

single preoperative dose of methylprednisolone

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael D'Angelica, MD

CONTACT

[email protected]

212-639-3226

Peter Kingham, MD

CONTACT

[email protected]

212-639-5260

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 2, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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