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Recruiting NCT07507643

A Study of Methylprednisolone in People Having Liver Surgery

Phase III Interventional Hepatectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methylprednisolone.
Who it may be relevant to
Registry conditions: Hepatectomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Controlled Trial of Methylprednisolone Versus Standard of Care in Patients Undergoing Major Hepatectomy

Overview

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.

Interventions

  • Drug Methylprednisolone
    single preoperative dose of methylprednisolone

Primary outcome measures

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 19 centers
  • Rush University Medical Center (Data collection only) — Chicago
  • University of Chicago (Data Collection Only) — Chicago
  • Indiana University (Data Collection Only) — Indianapolis
  • UNIVERSITY OF IOWA (Data Collection Only) — Iowa City
  • University of Kentucky (Data Collection Only) — Lexington
  • Henry Ford Hospital (Data collection only) — Detroit
  • Mayo Clinic (Data Collection Only) — Rochester
  • Washington University (Data Collection Only) — St Louis
  • … and 11 more centers

Identifiers

NCT: NCT07507643 · 26-077

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗