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Validation in a Non-targeted Population of Single Ultrasound Doppler Signs of Liver Fibrosis (DECHO2)

Primary Purpose

Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
elastography
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Angers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hepatic ultrasound

Arm Description

all patients will have hepatic ultrasound

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 19, 2017
Last Updated
January 19, 2017
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT03027921
Brief Title
Validation in a Non-targeted Population of Single Ultrasound Doppler Signs of Liver Fibrosis
Acronym
DECHO2
Official Title
Validation in a Non-targeted Population (Screening) of Single Ultrasound Doppler Signs of Liver Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2017 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hepatic ultrasound
Arm Type
Experimental
Arm Description
all patients will have hepatic ultrasound
Intervention Type
Other
Intervention Name(s)
elastography
Primary Outcome Measure Information:
Title
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.
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Chu Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoire Cartier, MD

12. IPD Sharing Statement

Learn more about this trial

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

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