NCT07507643 A Study of Methylprednisolone in People Having Liver Surgery
| NCT ID | NCT07507643 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Hepatectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2026-03-27 |
| Primary Completion | 2029-03-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 750 participants in total. It began in 2026-03-27 with a primary completion date of 2029-03-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Michael D'Angelica, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT07507643 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07507643 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 750 participants.
Is NCT07507643 currently recruiting?
Yes, NCT07507643 is actively recruiting participants. Contact the research team at dangelim@MSKCC.ORG for enrollment information.
Where is the NCT07507643 trial being conducted?
This trial is being conducted at Chicago, United States, Chicago, United States, Indianapolis, United States, Iowa City, United States and 11 additional locations.
Who is sponsoring the NCT07507643 clinical trial?
NCT07507643 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Michael D'Angelica, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 750 participants.