A Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection

Dartmouth-Hitchcock Medical Center65 enrolled

Overview

The purpose of this study is to measure the effect of a short-term low calorie diet on patients with a Body Mass Index (BMI) over 25 who are undergoing liver surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Nonalcoholic Fatty Liver Disease Hepatic Steatosis Steatohepatitis

Interventions

Optifast 800DIETARY_SUPPLEMENT

Five units of Optifast 800 plus an unlimited volume of calorie-free fluids per day for one week prior to hepatic resection.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 or greater * Clinical indication for a therapeutic liver resection * BMI of 25 kg/m2 or greater * Informed Consent Exclusion Criteria: * Inability to comply with the pre-op diet * Patients who have lost 5% or more of their usual body weight over the preceding one month * Female patients of childbearing age who have a positive pregnancy test

Locations (3)

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Fletcher Allen Health Care

Burlington, Vermont, United States

Outcomes

Primary Outcomes

The effect of a low calorie diet on intra-operative blood loss, technical ease of hepatic transection, complication rates (including infectious complications), length of stay and mortality in patients undergoing liver surgery.

Intra-operative blood loss will be strictly quantified. Units of autologous or donor blood transfused will be recorded. The surgeon will assess the ease of liver mobilization and parenchymal transection using a 1-5 scale where 1 is easy and 5 is hard. Post-operative complications, length of stay and mortality will be recorded.

Time frame: 30 days post-operatively

Secondary Outcomes

The effect of a low calorie diet on steatosis and steatohepatitis.

Using tissue from hepatic parenchyma adjacent to resected neoplasms steatosis and steatohepatitis will be evaluated by a pathologist blinded to dietary intervention. Steatosis will be defined as mild, moderate or severe if 5-33%, 34-66%, or \>66% of hepatocytes contain fat inclusions. Steatohepatitis will be defined using NAFLD (Non-Alcoholic Fatty Liver Disease) Activity Score (NAS) as an NAS 4 or greater, with \<4 defined as no steatohepatitis.

Time frame: 30 days post-operatively

The mechanism of decreased steatosis in patients undergoing a low-calorie pre-op diet by measuring levels of expression of molecules involved in the de novo synthesis, hepatic uptake and degradation of lipids.

Levels of expression of molecules involved in the de novo synthesis, hepatic uptake and degradation of lipids will be measured to evaluate the mechanism of decreased steatosis.

Time frame: 30 days post-operatively

Data from ClinicalTrials.gov

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