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

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.

Study Overview

• Status: Recruiting
• Conditions: Disease of Liver and Bile Duct
• Intervention / Treatment: Procedure: vibration controlled transient elastography (VCTE)

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Ajay Chaudhuri, MD; Phone Number: 716-907-1916; Email: achaudhu@buffalo.edu
• Study Contact Backup: Name: Andrew Talal, MD; Phone Number: 716-888-4737; Email: ahtalal@buffalo.edu

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • Conventus Medical Office Building
      • Contact: Ajay Chaudhuri, MD; Phone Number: 716-907-1916; Email: achaudhu@buffalo.edu
      • Principal Investigator: Ajay Chaudhuri, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• 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: hepatitis C virus (HCV)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

liver fibrosis and steatosis; 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.

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 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.; Other Names: fibroscan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of fibrosis in patients with varying degrees of liver disease	single event per patient with liver disease to measure degree of fibrosis concentration	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of liver fat in patients with varying degrees of liver disease	single event per patient with liver disease to measure degree of fat concentration	10 years

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Collaborators: Kaleida Health

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 3, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimated): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: FibroScan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED