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A Study of Methylprednisolone to Lower Side Effects in People Having Liver Surgery
Trial Status: active
This phase III trial studies whether giving methylprednisolone before surgery (preoperative) will lower the side effects after surgery (postoperative) in patients undergoing surgery to remove part of the liver (hepatectomy). Hepatectomy is the standard of care for the treatment of certain types of hepatobiliary (bile duct, gallbladder, liver and pancreatic cancers) tumors. Despite advances in the surgical procedure, patients continue to experience many side effects, such as infection and longer hospital stays, following hepatectomy. Methylprednisolone is a corticosteroid, a type of drug used to reduce inflammation and calm (suppress) the immune system. Corticosteroids are routinely given to help relieve swelling, redness, itching, and allergic reactions. Methylprednisolone is routinely given to people who have liver transplants, and it has been shown in a small number of people to reduce the effects from surgery. Giving methylprednisolone preoperatively may be an effective way to lower postoperative side effects in patients undergoing hepatectomy.
Inclusion Criteria
Age ≥ 18 years at the time of consent
Scheduled to undergo elective major hepatectomy (defined by Current Procedural Terminology [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., intraarticular)
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 human chorionic gonadotropin (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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07507643.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Michael D'Angelica
Phone: 212-639-3226
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Michael D'Angelica
Phone: 212-639-3226
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Michael D'Angelica
Phone: 212-639-3226
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Michael D'Angelica
Phone: 212-639-3226
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Michael D'Angelica
Phone: 212-639-3226
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Michael D'Angelica
Phone: 212-639-3226
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Michael D'Angelica
Phone: 212-639-3226
PRIMARY OBJECTIVE:
I. 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 patients undergoing elective major hepatectomy for all indications.
SECONDARY OBJECTIVE:
I. To individually assess the types of morbidities associated with the use of methylprednisolone, compared with the standard of care (no methylprednisolone), in patients undergoing elective major hepatectomy for all indications.
EXPLORATORY OBJECTIVE:
I. To assess laboratory measures of postoperative liver function (including aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, prothrombin time [PT], and international normalized ratio [INR]) and their relationship to the development of perioperative complications.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive a single dose of methylprednisolone intravenously (IV) prior to elective major hepatectomy.
ARM 2: Patients receive standard of care which may consist of administration of a single dose of low-dose corticosteroid at the discretion of the treating anesthesiologist prior to elective major hepatectomy.
After completion of study treatment, patients are followed up for 30 days.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
