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

NCT ID: NCT03027921

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-28

Brief 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.

Conditions

Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

hepatic ultrasound

all patients will have hepatic ultrasound

Group Type: EXPERIMENTAL

elastography

Intervention Type: OTHER

Interventions

elastography

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Angers

Angers, France, France

Countries

France

Facility Contacts

Victoire Cartier, MD

Role: primary

Other Identifiers

49RC16_0164

Identifier Type: -

Identifier Source: org_study_id