A care path for the detection of advanced NAFLD-fibrosis: the Nijmegen-Leiden-Amsterdam 2-tiered care path study

Recruiting

Conditions: obesitas
fatty liver
Non-alcoholic fatty liver disease
10019654
10012653

Registration Number: NL-OMON53438

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 730

Inclusion Criteria

- Age >= 18 years;
- Suspected by treating physician to suffer from a severe stage of
NAFLD-fibrosis.

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- The diagnostic accuracy of the three different sequential care path<br /><br>algorithms to detect underlying advanced (>=F3) liver fibrosis, assessed using<br /><br>sensitivity, specificity, predictive values and area under the receiver<br /><br>characteristics (AUROC) curve;<br /><br>- The diagnostic performance of the three different sequential care path<br /><br>algortithms, ed as the increase in correct and the decrease in unnecessary<br /><br>referrals when using these care paths to detect underlying advanced (>=F3)<br /><br>NAFLD-fibrosis compared to regular care. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The cost effectiveness of the different diagnostic modalities/care path<br /><br>algorithms compared to each other and to regular care;<br /><br>- Number of patients coded for NAFLD by hospital specialists and GPs before and<br /><br>after initiation of the NLA2 study (measure of awareness);<br /><br>- The diagnostic accuracy of the three individual non-invasive tests<br /><br>(FIB4-score, VCTE and ELF-test) to detect underlying advanced (>=F3) liver<br /><br>fibrosis, assessed using sensitivity, specificity, predicitive values and<br /><br>AUROC-curves;<br /><br>- The diagnostic performance of the three individual non-invasive tests<br /><br>(FIB4-score, VCTE and ELF-test), defined as the increase in correct and the<br /><br>decrease in unnecessary referrals when using these non-invasive tests to detect<br /><br>underlying advanced (>=F3) NAFLD-fibrosis compared to regular care. </p><br>