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

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

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).

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Liver Cirrhosis; Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Device: Ultrasound liver assessment

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33600
    • Bordeaux University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study arm	Device: Ultrasound liver assessment; The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.; Other Names: Elastography; Ultrasound attenuation; Sound speed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: E-Scopics
• Collaborators: University Hospital, Bordeaux
• Investigators: Principal Investigator: Victor de Lédinghen, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): August 29, 2022
• Study Completion (Actual): August 29, 2022

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound; Elastography; Attenuation; Sound speed
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Fibrosis; Liver Diseases; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: ES201; 2021-A00612-39 (Other Identifier: ANSM (France - n°IDRCB)); 21.01563.000015 (Other Identifier: Ethical committee CPP Est I)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No