?valuation of attenuation imaging (ATI) to elicit the degree of steatosis and shear wave dispersion mode (SWD) to quantify viscoelasticity in nonalcoholic steatohepatitis (NASH).
- Conditions
- K76.0Fatty (change of) liver, not elsewhere classified
- Registration Number
- DRKS00029983
- Lead Sponsor
- Medizinische Klinik 1, Klinikum der Goethe-Universität
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 244
Inclusion Criteria
Signed informed consent from the patient or legal guardian; Substudy 1: patients with NASH/NAFLD; Substudy 2: patients with hepatologic disease (NASH/NAFLD, AIH, ASH, chronic hepatitis B infection, chronic hepatitis C infection) and existing histologic findings of the liver
Age 18 years.
Exclusion Criteria
Incapacitated patients, pregnancy or lactation, patients with advanced liver cirrhosis and decompensation
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Substudy 1: <br>AUC, sensitivity and specificity of the degree of steatosis determined by Attenuation Imaging (ATI) by comparing the measured values with results of a CAP measurement and with results of a liver biopsy (histologically determined NAFLD activity score (NAS) and the Steatosis, Activity and Fibrosis Score (SAS), respectively). <br><br>Substudy 2: <br>AUC, sensitivity, and specificity of viscoelasticity determined by SWD by correlation with histologically assessed inflammation grade. <br><br>Supplementary to Substudy 1 and 2:<br>AUC, sensitivity and specificity of elasticity determined by SWE by comparing results with Transient Elastography (Fibroscan®) readings.
- Secondary Outcome Measures
Name Time Method Influence of comorbidities on the diagnostic accuracy of the degree of steatosis and viscoelasticity (obesity (BMI), ascites).