obesitas fatty liver Non-alcoholic fatty liver disease
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years; - Suspected by treating physician to suffer from a severe stage of NAFLD-fibrosis.
Exclusion criteria
Exclusion criteria: - Previous diagnosis of advanced (>=F3) liver fibrosis; - Any other known chronic liver disease (alcoholic steatohepatitis, hepatitis B, hepatitis C, autoimmune hepatitis, hemochromatosis, Wilsons disease, alpha-1-antitrypsin deficiency); - Drugs that may cause drug-induced hepatic steatosis (see protocol, table 1); - Present excessive alcohol use, defined as > 2 units/day for women and > 3 units/day for men; - A psychiatric, addictive or any other disorder that compromises the subject*s ability to understand the study content and to give written informed consent for the participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - The diagnostic accuracy of the three different sequential care path algorithms to detect underlying advanced (>=F3) liver fibrosis, assessed using sensitivity, specificity, predictive values and area under the receiver characteristics (AUROC) curve; - The diagnostic performance of the three different sequential care path algortithms, ed as the increase in correct and the decrease in unnecessary referrals when using these care paths to detect underlying advanced (>=F3) NAFLD-fibrosis compared to regular care. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The cost effectiveness of the different diagnostic modalities/care path algorithms compared to each other and to regular care; - Number of patients coded for NAFLD by hospital specialists and GPs before and after initiation of the NLA2 study (measure of awareness); - The diagnostic accuracy of the three individual non-invasive tests (FIB4-score, VCTE and ELF-test) to detect underlying advanced (>=F3) liver fibrosis, assessed using sensitivity, specificity, predicitive values and AUROC-curves; - The diagnostic performance of the three individual non-invasive tests (FIB4-score, VCTE and ELF-test), defined as the increase in correct and the decrease in unnecessary referrals when using these non-invasive tests to detect underlying advanced (>=F3) NAFLD-fibrosis compared to regular care. | — |
Countries
Netherlands
Outcome results
None listed