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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nonalcoholic Fatty Liver Disease, Hepatic Steatosis, Steatohepatitis

Intervention / Treatment
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* Dietary Supplement: Optifast 800


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No specified diet for one week prior to hepatic resection. | |
| Active Comparator: Low calorie diet<br>Low calorie diet (five units of Optifast 800 {Nestle Nutrition, Vevey, Switzerland} plus an unlimited volume of calorie free fluids per day) for one week prior to hepatic resection. | Dietary Supplement: Optifast 800<br>* Five units of Optifast 800 plus an unlimited volume of calorie-free fluids per day for one week prior to hepatic resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 30 days post-operatively |