Disease of Liver and Bile Duct
Conditions
Brief summary
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
PROCEDUREvibration 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 a given VCTE exam is the median value of at least 10 successful measurements. 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.
Sponsors
State University of New York at Buffalo
Kaleida Health
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measurement of fibrosis in patients with varying degrees of liver disease | 10 years | single event per patient with liver disease to measure degree of fibrosis concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| measurement of liver fat in patients with varying degrees of liver disease | 10 years | single event per patient with liver disease to measure degree of fat concentration |
Countries
United States
Contacts
CONTACTAjay Chaudhuri, MD
CONTACTAndrew Talal, MD
Outcome results
None listed