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Completed

NCT Number: NCT04782050

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

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bordeaux University Hospital

Pessac, 33600, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound liver assessment

Device

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

Other names: Elastography, Ultrasound attenuation, Sound speed

Primary outcomes

  1. Correlation of biomarkers to existing biomarker references

    Time frame: At study completion, 1 year

    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.

  2. Diagnostic performance of biomarkers in research

    Time frame: At study completion, 1 year

    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.

Secondary outcomes

  1. Repeatability intraclass correlation coefficients (ICC)

    Time frame: At study completion, 1 year

    Repeatability will be assessed by calculating the ICC across 2 series of measurements performed by the same operator.

  2. Reproducibility intraclass correlation coefficients (ICC)

    Time frame: At study completion, 1 year

    Reproducibility will be assessed by calculating the ICC across 2 series of measurements performed by 2 different operators.

Sponsors and collaborators

Lead sponsor

E-Scopics

Industry

Collaborators

  • University Hospital, Bordeaux

Registry information

Official study title

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

Acronym: DIACEPA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2021
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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