Methylprednisolone Before Major Liver Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Memorial Sloan Kettering Commack (Data Collection Only)
  Commack, New York, United States Recruiting
• Memoral Sloan Kettering Westchester (Data Collection Only)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting
• Rush University Medical Center (Data collection only)
  Chicago, Illinois, United States Not yet recruiting
• University of Chicago (Data Collection Only)
  Chicago, Illinois, United States Not yet recruiting
• Indiana University (Data Collection Only)
  Indianapolis, Indiana, United States Not yet recruiting

Study contacts

• Principal investigator: Michael D'Angelica, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Michael D'Angelica, MD
• Email: dangelim@MSKCC.ORG
• Phone: 212-639-3226

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.