Validation in a Non-targeted Population of Single Ultrasound Doppler Signs of Liver Fibrosis

Cirrhosis Clinical Trial

— DECHO2  

Official title:

Validation in a Non-targeted Population (Screening) of Single Ultrasound Doppler Signs of Liver Fibrosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03027921
• Other study ID #: 49RC16_0164
• Status: Not yet recruiting
• Phase: N/A
• First received: January 19, 2017
• Last updated: January 19, 2017
• Start date: February 2017

Study information

• Verified date: January 2017
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The diagnosis of liver fibrosis lesions remains an important issue in patients with chronic liver diseases. The early detection of fibrosis is important for determining disease progression and postponing the evolution of chronic hepatitis into cirrhosis via the implementation of prompt and specific treatment. However, as chronic liver disease can remain asymptomatic for a long time, numerous cirrhotic patients are diagnosed belatedly, when life-threatening complications start appearing.

Noninvasive methods for liver fibrosis diagnosis have been developed over the last decade. In this setting, blood fibrosis tests and transient elastography have been shown to be accurate, and are now commonly used as first-intention tests for liver fibrosis diagnosis in chronic liver diseases. However, these tests are usually performed by a hepatologist to whom the patient has been referred following the appearance of symptoms suggestive of chronic liver disease. Thus the number of patient diagnosed early by these new tools, that is in the period before symptoms start appearing and during which preventative measures may be particularly beneficial, remains quite low in relation to the prevalence of the disease. This prevalence has been estimated to 0.5 to 2.8 % in general population.

Many studies have identified the value of hemodynamic and morphological ultrasound parameter in providing information on liver fibrosis degree. Moreover, abdominal ultrasound is widely used for various symptoms, and thus could be an excellent way to detect patients with signs evoking liver fibrosis or cirrhosis, who could then be referred to a liver specialist for confirmation of the diagnosis by blood fibrosis tests and/or transient elastography. To be feasible during a nonspecific US examination, and by any radiologist, these signs should be easy and quick to collect. Addition of a quick measure of hepatic stiffness could increase the screening interest of ultrasound examination.

The main aim of the present study was thus to validate 3 simple US signs in patients referred for ultrasound abdominal examination for reasons other than suspicion of liver disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients referred to an ultrasound unit for abdominal US examination, whatever the indication.

• Patient with Social Security

Exclusion Criteria:

• Age <18 years

• Previously identified chronic liver disease

• Hematological disease

• Patient under guardianship

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis

Intervention

Other:
• elastography

Locations

Country	Name	City	State
France	Chu Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the number of patients with severe hepatic fibrosis detected by a progressive algorithm combining simple ultrasound signs of fibrosis and measurement of liver hardness in a non-suspect population of chronic hepatopathies.		6 month