This randomized phase II trial studies how well octreotide acetate works in enhancing liver recovery in patients with liver tumor after surgery. Octreotide acetate may enhance liver recovery in patients who undergo major hepatectomy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03179995.
PRIMARY OBJECTIVE:
I. To compare the rates of liver recovery in patients treated with octreotide acetate (octreotide) versus (vs) placebo after a major hepatectomy.
SECONDARY OBJECTIVES:
I. To compare the rates of hepatic parenchymal regeneration in patients treated with octreotide vs placebo after major liver hepatectomy.
II. Evaluate the incidence of post-hepatectomy liver failure, bile leak, overall as well as 30-day and 90 day morbidity and mortality using American College of Surgeons-National Surgical Quality Improvement Definitions (ACS-NSQIP).
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients receive octreotide acetate intravenously (IV) hourly beginning during surgery and continuing over 5 days.
ARM II: Patients receive placebo IV hourly beginning during surgery and continuing over 5 days.
After completion of study, patients are followed up at 2 weeks and at 3 and 6 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationFox Chase Cancer Center
Principal InvestigatorSanjay Reddy
