CirrhosisDECHO2NCT03027921
Validation in a Non-targeted Population of Single Ultrasound Doppler Signs of Liver Fibrosis
A study testing elastography in people with Cirrhosis, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- elastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2017to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred to an ultrasound unit for abdominal US examination, whatever the indication.
- Patient with Social Security
Who cannot join
- Age <18 years
- Previously identified chronic liver disease
- Hematological disease
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation in a Non-targeted Population (Screening) of Single Ultrasound Doppler Signs of Liver Fibrosis
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.
Read more
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
- Being tested
- elastography
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elastographyOther
| Study group | Role | What they receive |
|---|---|---|
| hepatic ultrasound | Experimental | all patients will have hepatic ultrasound Receives: Other: elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startFeb 2017
- Primary completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027921
- Sponsor's protocol ID
- 49RC16_0164
- Acronym
- DECHO2
- Status last verified
- Jan 2017
- First submitted
- 19 Jan 2017
- Last updated
- 23 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation in a Non-targeted Population (Screening) of Single Ultrasound Doppler Signs of Liver Fibrosis
- ClinicalTrials.gov ID
- NCT03027921
- Acronym / sponsor ID
- DECHO2 / 49RC16_0164
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Feb 2017
- Primary completion
- Feb 2018 (estimated)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hepatic ultrasound | Experimental | Other: elastographyall patients will have hepatic ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred to an ultrasound unit for abdominal US examination, whatever the indication.
- Patient with Social Security
Key exclusion criteria (4 listed)
- Age <18 years
- Previously identified chronic liver disease
- Hematological disease
- Patient under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elastography | Other | hepatic ultrasound |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing elastography in people with Cirrhosis, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.