This randomized phase II trial studies how well a low calorie diet works in reducing side effects in patients undergoing liver surgery. Eating a low calorie diet may lower the risk of complications during and after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01645852.
PRIMARY OBJECTIVES:
I. To determine the effect of a low calorie diet on short term clinical outcomes of patients undergoing liver surgery. These include intra-operative blood loss, technical ease of hepatic transection, complication rates (including infectious complications), length of stay and mortality.
SECONDARY OBJECTIVES:
I. To determine the effect of a low calorie diet on hepatic steatosis and steatohepatitis.
II. To evaluate the mechanism of decreased steatosis in patients undergoing a low calorie pre-operative (op) diet by measuring levels of expression of molecules involved in the de novo synthesis, hepatic uptake and degradation of lipids.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients consume a low-calorie diet comprising 5 units of Optifast 800 per day or an alternative food diet with equivalent nutritional content, unlimited calorie free fluids, and 1 multivitamin orally (PO) once daily (QD) for 1 week prior to liver surgery.
ARM II: Patients receive a multivitamin PO QD for 1 week prior to liver surgery.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Principal InvestigatorRichard J. Barth
