Non-invasive Liver Screening Using FibroScan Device for Liver Disease Patients for the Steatosis/Fibrosis Database

University at Buffalo (UB)

Status: Enrolling

Conditions: Disease of Liver and Bile Duct

Treatments: Procedure: vibration controlled transient elastography (VCTE)

Study type: Observational

Funder types: Other

Identifiers

NCT02897908

FibroScan

Details and patient eligibility

About

The primary goal of this study is to establish a database of people with varying levels of hepatic fibrosis and various etiologies of liver disease for use in future research protocols.

Full description

The Fibroscan device will determine liver stiffness as well as the amount of fat through another application on the machine called controlled attenuation parameter or Controlled Attenuation Parameters (CAP). The liver stiffness measurements are then translated into a score that tells how much liver fibrosis or fat is present. Patients identified with potential for fatty liver or specific liver-related diseases causing fibrosis would be approached for a voluntary FibroScan measurement. From these patients, the investigators will collect information related to demographics, disease history, medical comorbidities, social history, laboratory and radiologic parameters. This information, along with clinical data associated with the patient will be placed in a database for use in identifying potential subjects for future trials.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with known, or suspected risk factors for steatosis (fat) or hepatic fibrosis
• Subjects who have been previously diagnosed with Non-Alcoholic Steatohepatitis (NASH) but who do not have current steatosis (fat) or fibrosis scoring
• Subjects who have other known liver diseases ie: HCV

Exclusion criteria

• Patients less than 18 years of age
• Pregnancy
• Patients that do not want to be contacted for consideration in future research studies.
• Patients diagnosed with ascites or peritoneal dialysis
• Body mass index (BMI) ≥40

Trial design

1,000 participants in 1 patient group

liver fibrosis and steatosis

Description:

measurements of liver fibrosis and steatosis will be obtained using Vibration controlled transient elastography FDA approved device- FibroScan for the purpose of building a data base of potential subjects for future research.

Treatment:

Procedure: vibration controlled transient elastography (VCTE)