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New treatment option for Hepatectomy
Official title A Study of Methylprednisolone in People Having Liver Surgery
ClinicalTrials.gov ID: NCT07507643
What this study is testing
What is Methylprednisolone?
Methylprednisolone is an investigational medicine, being studied as a potential treatment for hepatectomy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- In addition to major hepatectomy, as defined above, patients may undergo additional partial hepatectomy or operative ablation.
You likely can't join if
- 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...
- 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...
- Expected or highly likely to undergo biliary tree reconstruction via creation of a biliary-enteric anastomosis.
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- New Brunswick, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- Manhasset, New York, United States
- New York, New York, United States
- Syracuse, New York, United States
- Durham, North Carolina, United States
- La Crosse, Wisconsin, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Indianapolis, Indiana, United States; Iowa City, Iowa, United States; Lexington, Kentucky, United States; Detroit, Michigan, United States; Rochester, Minnesota, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.