Liver Steatosis
Conditions
Brief summary
The assessment of liver fat content is important in patients suspected of or diagnosed with chronic liver disease. Non-alcoholic fatty liver disease (NAFLD) is defined by the presence of hepatic fat content ≥5% of hepatocytes. NAFLD is currently the most common chronic liver disease worldwide with an estimated prevalence of 5-30% in the general population and in 55% up to 80% of patients with type 2 diabetes. New ultrasound methods for a non-invasive and quantitative assessment of the liver fat content have recently been developed. They are based on the estimation of the attenuation coefficient of the ultrasound beam. Our group has conducted studies to evaluate the performance of the attenuation coefficient available on the Aplio i800 ultrasound system (ATI, Canon Medical Systems). The Aplio i800 ultrasound system has already a CE mark, and is available at our Ultrasound Unit for research purposes. ATI has showed a high accuracy for the quantification of liver fat, and was more accurate than the controlled attenuation parameter (CAP, FibroScan) in assessing significant steatosis. The aim of the study is therefore the optimization of the acquisition protocol of ATI measurements on the system Aplio i800, which has already a CE mark.
Interventions
None listed
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Informed consent * Healthy adult volunteers (\> 18 years) * Ability to suspend respiration for image acquisition
Exclusion criteria
* Pregnancy * age \< 18 years * Presence of ascites, acute viral hepatitis, transaminase flares, congestive heart failure, infiltrative diseases. * No major medical conditions and in particular no known hepatic diseases * Any other condition that, upon clinical judgment of the investigator, will make unacceptable the study participation for that individual subject * Consent withdrawal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of the concordance of attenuation coefficient measurements taken with different technical approaches | up to 3 years | Technical parameters considered are the position of the transducer, Breath-hold versus free breathing , Depth dependency, Intercostal approach vs subcostal vs left lobe, Separate acquisition of the attenuation coefficient versus simultaneous acquisition in "QUAD view" mode (stiffness / dispersion / ATI), Measurements of the attenuation coefficient using different ultrasound windows |
Secondary
| Measure | Time frame |
|---|---|
| evaluation of the different parameters for measuring the attenuation coefficient determinates limits of agreement (LoA) that are larger than a pre-defined maximum allowed difference (Δ) in a Bland and Altman plot | up to 3 years |
| evaluation of the results and whether they are influenced by food intake | up to 3 years |
| evaluation of the results and whether they are influenced by the level of hydration | up to 3 years |
Countries
Italy
Outcome results
None listed