Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard diagnostic procedures.
- Who it may be relevant to
- Registry conditions: Liver Cirrhoses. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Standard diagnostic procedures
B-Mode ultrasound, Duplex sonography, contrast-enhanced ultrasound, elastography, CT, MRI, anthropometrics
Primary outcome measures
- Diagnostic accuracy [Time frame: 1 year]
Secondary outcome measures (1)
- Predictive Value [Time frame: up to 5 years]
Eligibility criteria
Inclusion criteria
- all patients with focal liver lesions and liver cirrhosis
Exclusion criteria
- no consent
- under 18 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Hospital Bonn — Bonn
Identifiers
NCT: NCT03746210 · NICETIES