Cirrhosis, Liver Fibrosis
Conditions
Keywords
Adult patients with chronic liver disease scheduled for a liver biopsy and a BMI superior or equal to 28 kg/m²
Brief summary
The main objective of the study is to evaluate the diagnostic performance of the XL probe for estimating degree of liver fibrosis/cirrhosis in obese patients \> 28 kg/m² with various liver diseases in patients with chronic liver disease scheduled for a liver biopsy.
Interventions
DEVICEFibroScan M and XL probes
Each patient undergo two liver stiffness measurements with the FibroScan: once with the M probe and once with the XL probe
Sponsors
Echosens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient of at least 18 years of age * Patient able to give written informed consent form * Patient with a BMI superior or equal to 28kg/m² * Patient scheduled to have a liver biopsy within 1 month after the enrollment or with a liver biopsy performed within 6 months before the enrollment. * Patient for which abdominal ultrasound is technically possible
Exclusion criteria
* Unable or unwilling to provide written informed consent * Confirmed diagnosis and/or history of malignancy, or other terminal disease * Patients with clinical ascites * Pregnant women * Patient with a BMI \< 28 kg/m² * Patients with any active implantable medical device (such as pacemaker or defibrillator) * Transplanted patient and patient with heart disease * Refusal to undergo a liver biopsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| diagnosis accuracy for the assement of significant fibrosis and cirrhosis | at enrollement |
Countries
Canada
Outcome results
None listed