A Study of Methylprednisolone in People Having Liver Surgery
Purpose
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.
Condition
- Hepatectomy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1: Methylprednisolone |
|
|
|
No Intervention Cohort 2: No Steroid |
|
Recruiting Locations
Memorial Sloan Kettering Commack (Data Collection Only)
Commack, New York 11725
Commack, New York 11725
Contact:
Michael D'Angelica, MD
212-639-3226
Michael D'Angelica, MD
212-639-3226
Memoral Sloan Kettering Westchester (Data Collection Only)
Harrison, New York 10604
Harrison, New York 10604
Contact:
Michael D'Angelica, MD
212-639-3226
Michael D'Angelica, MD
212-639-3226
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
New York, New York 10065
Contact:
Michael D'Angelica, MD
212-639-3226
Michael D'Angelica, MD
212-639-3226
More Details
- Status
- Recruiting
- Sponsor
- Memorial Sloan Kettering Cancer Center