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

NCT04782050 | Completed

• 3 other identifiers: ES2012021-A00612-3921.01563.000015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

Elastography; Attenuation; Sound speed; Ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Repeatability intraclass correlation coefficients (ICC)

  At study completion, 1 year

• Reproducibility intraclass correlation coefficients (ICC)

  At study completion, 1 year

Study Arms (1)

Study arm

EXPERIMENTAL

Device: Ultrasound liver assessment

Interventions

Ultrasound liver assessment DEVICE

The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.

Also known as: Elastography, Ultrasound attenuation, Sound speed

Study arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• E-Scopics: lead
• University Hospital, Bordeaux: collaborator

Study Sites (1)

Bordeaux University Hospital

Pessac, 33600, France

Location

MeSH Terms

Conditions

Liver Diseases; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatty Liver

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Victor de Lédinghen, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All patients recruited will receive routine care for liver assessment followed by an exam using the device subject of the research.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: September 15, 2021
• Primary Completion: August 29, 2022
• Study Completion: August 29, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

FR (1)