Hepatectomy
Conditions
Keywords
Hepatectomy, Methylprednisolone, Memorial Sloan Kettering Cancer Center, 26-077
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.
Interventions
DRUGMethylprednisolone
single preoperative dose of methylprednisolone
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in 30-day all-cause morbidity between Cohort 1 and Cohort 2 | 30 days | To determine whether the administration of preoperative methylprednisolone will result in lower 30-day all-cause morbidity, compared with the standard of care (no methylprednisolone), in participants undergoing elective major hepatectomy for all indications. |
Countries
United States
Contacts
CONTACTMichael D'Angelica, MD
CONTACTPeter Kingham, MD
PRINCIPAL_INVESTIGATORMichael D'Angelica, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed