A Study of Methylprednisolone in People Having Liver Surgery (NCT07507643)
A Randomized Controlled Trial of Methylprednisolone Versus Standard of Care in Patients Undergoing Major Hepatectomy
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (13 items).
Location: Rush University Medical Center (Data collection only) — Chicago, Illinois
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (19 Sites)
- Rush University Medical Center (Data collection only) — Chicago, Illinois
- University of Chicago (Data Collection Only) — Chicago, Illinois
- Indiana University (Data Collection Only) — Indianapolis, Indiana
- UNIVERSITY OF IOWA (Data Collection Only) — Iowa City, Iowa
- University of Kentucky (Data Collection Only) — Lexington, Kentucky
- Henry Ford Hospital (Data collection only) — Detroit, Michigan
- Mayo Clinic (Data Collection Only) — Rochester, Minnesota
- Washington University (Data Collection Only) — St Louis, Missouri
- University of Nebraska Medical Center (Data Collection Only) — Omaha, Nebraska
- Rutgers University (Data Collection Only) — New Brunswick, New Jersey
- Memorial Sloan Kettering Commack (Data Collection Only) — Commack, New York
- Memoral Sloan Kettering Westchester (Data Collection Only) — Harrison, New York
- Northwell Health (Data collection only) — Manhasset, New York
- New York University (Data Collection Only) — New York, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York
- SUNY Upstate Medical University — Syracuse, New York
- Duke University (Data Collection Only) — Durham, North Carolina
- Gundersen Lutheran Medical Foundation (Data Collection Only) — La Crosse, Wisconsin
- University of Wisconsin (Data Collection Only) — Madison, Wisconsin
📞 Contact the Study Coordinator
Phone: (212) 639-3226
Email: dangelim@MSKCC.ORG
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.