Chronic Hepatitis C
Conditions
Brief summary
This study will evaluate the effectiveness of Acoustic Radiation Force Impulse (ARFI)- Imaging compared to Transient Elastography (FibroScan) in differentiating liver fibrosis in patients with chronic hepatitis C. Patients who are scheduled to have a liver biopsy will also undergo ARFI and FibroScan testing. The liver biopsy will be used as the reference method. The target sample size is 433.
Interventions
DEVICEFibroScan
DEVICEAcoustic Radiation Force Impulse (ARFI)- Imaging
Sponsors
Johann Wolfgang Goethe University Hospital
Study design
Primary purpose
DIAGNOSTIC
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, 18-79 years old * Written consent * Chronic Hepatitis C infection * Liver biopsy planned or performed within the last six months * In addition, 10 patients/center with proven liver cirrhosis without present liver biopsy can be included
Exclusion criteria
* Consuming illness (HIV infection, malignoma) * Comorbidities associated to HCV (HBV, NASH, hemochromatosis, primary sclerosing cholangitis, primary biliary cirrhosis * Antiviral therapy between liver biopsy and study inclusion * Pacemaker or heart defibrillator * Pregnancy or lactation * Liver transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority of AUROCs of Acoustic Radiation Force Impulse (ARFI)- Imaging to Transient Elastography (Fibroscan) for assessment of liver fibrosis in patients with chronic hepatitis C using liver biopsy as the reference standard. | — | The diagnostic accuracy measured with the Area under the ROC curve (AUROC) is calculated for Acoustic Radiation Force Impulse (ARFI)- Imaging and Transient Elastography (Fibroscan) using histology obtained by liver biopsy as reference method in patients infected with chronic hepatitis C. The ROC curve represents sensitivity versus 1-specificity for all possible cut-off values for prediction of the different fibrosis stages, respectively. The areas under the curves (AUROC) as well as 95 % CI of AUROC are calculated. |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of AUROC of ARFI-Imaging and Transient Elastography with FibroMax (liver fibrosis marker) | — |
| Comparison of AUROC of ARFI and Transient Elastography with the European Liver Fibrosis-Group Marker (ELF) | — |
| Evaluation of a combination of non-invasive methods for optimising AUROC for the assessment of liver fibrosis | — |
| Evaluation of factors associated with measurement failure of ARFI-Imaging and Transient Elastography | — |
| Assessment of center variability of results | — |
Countries
France, Germany, Netherlands
Outcome results
None listed