A Study of Methylprednisolone in People Having Liver Surgery (NCT07507643) | Clinical Trial Compass
RecruitingPhase 3
A Study of Methylprednisolone in People Having Liver Surgery
United States750 participantsStarted 2026-03-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 d…
What they're measuring
1
Difference in 30-day all-cause morbidity between Cohort 1 and Cohort 2