Recruiting
Phase 3

Methylprednisolone

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07507643

Conditions

Hepatectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Methylprednisolone

Study Details

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.

Conditions

Hepatectomy

Study ID

NCT07507643

Start date

Mar 27, 2026

Status verified date

Jul, 2026

Completion date

Mar 27, 2029

Anticipated

Primary completion date

Mar 27, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Methylprednisolone

no intervention: Cohort 2: No Steroid

Interventions

Methylprednisolone

single preoperative dose of methylprednisolone

Primary outcome measure

  • Difference in 30-day all-cause morbidity between Cohort 1 and Cohort 2 [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Michael D'Angelica, MD

212-639-3226dangelim@MSKCC.ORG

Peter Kingham, MD

212-639-5260kinghamP@mskcc.org

Locations

Memorial Sloan Kettering Commack (Data Collection Only)

Recruiting

Commack, New York, United States, 11725

Contacts

Michael D'Angelica, MD

212-639-3226

Memoral Sloan Kettering Westchester (Data Collection Only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Michael D'Angelica, MD

212-639-3226

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Michael D'Angelica, MD

212-639-3226

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Hepatectomy
  • Methylprednisolone
  • Memorial Sloan Kettering Cancer Center
  • 26-077

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-07.