Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis
- Conditions
- Liver Cirrhoses
- Registration Number
- NCT03746210
- Lead Sponsor
- University Hospital, Bonn
- Brief Summary
This study aims to analyze non-invasive characterization focal liver lesions in patients with liver cirrhosis. The diagnostic accuracy and predictive value of non-invasive methods is studied.
- Detailed Description
This study aims to analyze non-invasive characterization focal liver lesions in patients with liver cirrhosis. The diagnostic accuracy and predictive value of non-invasive methods is studied.
Upon diagnosis multiparametric ultrasound imaging of the lesions as well as sarcopenia parameters are performed for characterization of the lesions. For primary endpoint the results are then analyzed with regard to diagnostic accuracy compared to gold standard (CT, MRI or histology). For secondary endpoint, predictive value of the non-invasive diagnostics are analyzed with regards to mortality and response to treatment.
All work up, treatment and follow up are applied in standard of care fashion.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- all patients with focal liver lesions and liver cirrhosis
- no consent
- under 18 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracy 1 year The diagnostic accuracy of non-invasive imaging of focal liver lesions in liver cirrhosis compared to gold standard (histology, CT and/or MRI)
- Secondary Outcome Measures
Name Time Method Predictive Value up to 5 years The predictive value on mortality and treatment response of non-invasive imaging of focal liver lesions in liver cirrhosis
Trial Locations
- Locations (1)
University Hospital Bonn
🇩🇪Bonn, Germany