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

NCT03027921 | Unknown

• 1 other identifier: 49RC16_0164
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

hepatic ultrasound

EXPERIMENTAL

all patients will have hepatic ultrasound

Other: elastography

Interventions

elastography OTHER

hepatic ultrasound

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Age \<18 years
• Previously identified chronic liver disease
• Hematological disease
• Patient under guardianship

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Chu Angers

Angers, France, 49933, France

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: February 1, 2017
• Primary Completion: February 1, 2018
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

FR (1)