A Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control No specified diet for one week prior to hepatic resection. |
|
| Active Comparator: Low calorie diet 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
Five units of Optifast 800 plus an unlimited volume of calorie-free fluids per day for one week prior to hepatic resection.
|
Outcome Measures
Primary Outcome Measures
- 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. [30 days post-operatively]
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.
Secondary Outcome Measures
- The effect of a low calorie diet on steatosis and steatohepatitis. [30 days post-operatively]
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.
- 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. [30 days post-operatively]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 or greater
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Clinical indication for a therapeutic liver resection
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BMI of 25 kg/m2 or greater
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Informed Consent
Exclusion Criteria:
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Inability to comply with the pre-op diet
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Patients who have lost 5% or more of their usual body weight over the preceding one month
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Female patients of childbearing age who have a positive pregnancy test
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UMass Memorial Medical Center | Worcester | Massachusetts | United States | 01655 |
| 2 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 3 | Fletcher Allen Health Care | Burlington | Vermont | United States | 05401 |
Sponsors and Collaborators
- Dartmouth-Hitchcock Medical Center
Investigators
- Principal Investigator: Richard J. Barth, MD, Dartmouth-Hitchcock Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DMS 12052