Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation (DIACEPA)

E-Scopics

Status: Completed

Conditions: Liver Cirrhosis; Non-Alcoholic Fatty Liver Disease; Liver Diseases

Treatments: Device: Ultrasound liver assessment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04782050

21.01563.000015 (Other Identifier)

2021-A00612-39 (Other Identifier)

ES201

Details and patient eligibility

About

Early screening and monitoring of chronic liver diseases in hepatology practice has become crucial. To achieve this goal, hepatology clinics need simple and available tools at the point-of-care to perform disease severity assessment. The objective of this study is to assess the performance of a new non-invasive ultrasound-based system for the assessment of liver fibrosis and steatosis severity, via ultrasound biomarkers such as tissue stiffness (correlated to fibrosis severity) and ultrasound tissue attenuation (correlated to steatosis extent).

Full description

The study will enroll adult patients with known chronic liver disease, and referred to a hepatology outpatient visit for liver fibrosis assessment.

Performances will be assessed from correlation coefficients between biomarkers estimated by the medical device subject of the research and reference measurements obtained non-invasively from other commercially available equipment.

Repeatability and reproducibility of biomarkers estimations by the medical device subject of the research will be assessed from intraclass correlation coefficients.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with known chronic liver disease and referred to the outpatient hepatology clinic for a consultation focused on chronic liver disease severity assessment, independently of the study (=in routine patient care).
• Patient who voluntarily consents to participate in the study, after being informed on study objectives and personal rights
• Patient who is registered to the French social security program

Exclusion criteria

• Adult patients under guardianship
• Adult patients not being under guardianship, unable to express consent for participation
• Pregnant women
• Breastfeeding women
• Patients under deprivation of liberty
• In-hospital patients not having given their consent to participate, or admitted in emergency
• Patients admitted in social and care centers for other reasons than those of the research
• Patients enrolled in other studies that have the potential to interfere with current research, or during the exclusion period forced by their participation in other research.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Study arm

Experimental group

Treatment:

Device: Ultrasound liver assessment