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

Liver Cirrhosis Clinical Trial

— DIACEPA  

Official title:

Diagnostic échographique Non-invasif Des Maladies Chroniques du Foie en Consultation d'hépatologie

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782050
• Other study ID #: ES201
• Secondary ID: 2021-A00612-3921
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: August 29, 2022

Study information

• Verified date: April 2023
• Source: E-Scopics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 29, 2022
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Cirrhosis
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Device:
• Ultrasound liver assessment
The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Pessac

Sponsors (2)

Lead Sponsor	Collaborator
E-Scopics	University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of biomarkers to existing biomarker references	Biomarkers measurements performed with the device subject of the research and commercially available equipment (2 other devices used in routine care) will be compared by analysis of correlation. The analysis outcome will be the R² coefficient and its p value.	At study completion, 1 year
Primary	Diagnostic performance of biomarkers in research	Area under the receiver operating characteristic (ROC) curve will be used an a general assessment of diagnostic performance against dichotomized population according to commercially available diagnostic biomarkers.; Conventional diagnostic estimators in the studied population will be derived from the ROC analysis: sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy.	At study completion, 1 year
Secondary	Repeatability intraclass correlation coefficients (ICC)	Repeatability will be assessed by calculating the ICC across 2 series of measurements performed by the same operator.	At study completion, 1 year
Secondary	Reproducibility intraclass correlation coefficients (ICC)	Reproducibility will be assessed by calculating the ICC across 2 series of measurements performed by 2 different operators.	At study completion, 1 year