Non-invasive Liver Screening Using FibroScan Device for Liver Disease Patients for the Steatosis/Fibrosis Database
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: vibration controlled transient elastography (VCTE).
- Who it may be relevant to
- Registry conditions: Disease of Liver and Bile Duct. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Procedure vibration controlled transient elastography (VCTE)
Once on the examination table, the subject will be instructed to place the right arm under their head and to cross their right ankle over the left ankle. The subject will then be asked to slightly bend to the left side to open the intercostal space. Subsequently, a handheld probe is placed in the intercostal space overlaying the right hepatic lobe. The velocity of returning shear waves, measured at a depth of 25-65 mm, is converted into a liver stiffness measurement (LSM). The LSM obtained from
Primary outcome measures
- measurement of fibrosis in patients with varying degrees of liver disease [Time frame: 10 years]
Secondary outcome measures (1)
- measurement of liver fat in patients with varying degrees of liver disease [Time frame: 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Conventus Medical Office Building — Buffalo
Identifiers
NCT: NCT02897908 · FibroScan