Use of Ultrasound Tools to Refer Patients at Risk of Chronic Liver Disease to the Hepatology Consultation (US-REFERRAL)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Positive Predictive Value for significant fibrosis
Study Overview
Brief Summary
Patients identified as being at risk of liver fibrosis because of a positive Fibrosis-4 (FIB-4) test in the primary care setting will be offered be enrolled in the trial and to undergo an Hepatoscope exam (external non-invasive ultrasound imaging exam) to screen for liver fibrosis (with stiffness measurements) and/or steatosis (with ultrasound parameters related to fatty liver). All patients presenting with a liver stiffness value of at least 6.5 kilopascal (kPa) will be referred to the tertiary hepatology consultations for further assessment. Hepatoscope measurements will be compared to the standard of care for these patients, as defined at the tertiary hepatology center.
Detailed Description
Chronic liver diseases (CLD) remain asymptomatic for a long time, until they become decompensated (cirrhosis) or lead to liver cancer. CLD all have a very similar natural history: over several years, or even tens of years, liver fibrosis develops progressively, which leads to cirrhosis and the related risks of complications of cirrhosis, including portal hypertension, liver failure, of even liver cancer.
In the absence of complications, liver fibrosis and cirrhosis remain completely symptomatic. For this reason, several methods for the non-invasive assessment of liver fibrosis have been developed over the last 20 years, with the objective to screen for liver fibrosis in it early stage so as to manage the patient and potentially prevent to development of complications. There are 2 groups of such noninvasive methods: blood-based tests and methods that measure the liver stiffness, which is directly correlated to liver fibrosis severity.
There are simple blood tests such as the FIB-4 and others can be more complex like FibroTest.
The FIB-4 test, which takes into account 4 parameters easily available (age, platelets, and 2 liver enzymes, AST and ALT), is very useful in the general population because of its high negative predictive value. However, it is mainly used for the diagnosis of liver fibrosis in the context of chronic viral hepatitis.
The measurement of liver stiffness is currently available on a hepatology-dedicated device, the FibroScan, or on high-end ultrasound imaging systems that are available in radiology centers. This measurement of liver stiffness has demonstrated excellent performances for the diagnosis of cirrhosis and a good performance for the assessment of liver fibrosis severity at earlier stages. However, in clinical practice, this method is not widely available nor accessible (cost of equipment of limited to radiology centers).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with any of the following
- •Elevated liver enzymes (AST, ALT, Gamma-GT, AP)
- •Type 2 diabetes
- •Elements of metabolic syndrome
- •Patients who consent in written to participate in the Clinical Investigation after being orally informed on the objectives and methods of the Clinical Investigation
Exclusion Criteria
- •Patients with active implants such as pacemakers, defibrillators, pumps, etc.
- •Patients presenting wounds at the location where the Hepatoscope probe shall be placed on patients' skin,
- •Pregnant and breastfeeding women,
- •People deprived of their freedom rights.
Arms & Interventions
Investigational Arm
Single arm study protocol
Intervention: Hepatoscope (Device)
Outcomes
Primary Outcomes
Positive Predictive Value for significant fibrosis
Time Frame: at study completion: 12 months
Estimation of Positive Predictive Value in percentage with 95% confidence interval for estimation of significant fibrosis.
Secondary Outcomes
- Diagnostic performance of liver stiffness measurements(at study completion: 12 months)
- Concordance of stiffness measurements(at study completion: 12 months)
- Correlation of stiffness measurements(at study completion: 12 months)