Chronic Liver Diseases (CLD)NCT01900808
Improvement of Transient Elastography Applicability and Diagnostic Accuracy to Identify Significant Fibrosis by Experienced Operators Using the M and XL Probe.
An observational study of Chronic Liver Diseases (CLD), run by Parc de Salut Mar at 1 site in Spain.
Trial summary
Transient elastography (TE)is the reference method to identify liver stiffness (LSM) but fails to obtain a measurement in 3% of cases and results are considered unreliable in 16%. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Liver Diseases (CLD)
- What is being tested?
- Trained operator with M probe., Experienced operator with M probe. and Experienced operator with XL probe.
- Type of treatment
- Medical device
- How many people
- 868 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2012to Dec 2012
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with liver stiffness
Who may be able to join
- Patients with chronic liver disease evaluated with TE by trained operators (experience <500 explorations).
- Signed inform consent.
- Aged between 18-90.
Who cannot join
- Patients with ascites.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Transient elastography (TE)is the reference method to identify liver stiffness (LSM) but fails to obtain a measurement in 3% of cases and results are considered unreliable in 16%. The aim of this study is to evaluate the applicability and diagnostic accuracy of TE performed by trained operators (<500 explorations), after a second evaluation by experienced explorers (>500 explorations) and after a third exploration using XL probe. Inadequate LSM will be re-evaluated by experienced operators with the M (standard size) probe. A third register will be performed with XL (obese size) probe in those patients with inadequate M probe determination. Diagnostic accuracy will be estimated in patients with liver biopsy to identify significant fibrosis with a TE cut-off value of 7.6 kPa (kilo pascal).
- Conditions
- Chronic Liver Diseases (CLD)
- Being tested
- Trained operator with M probe., Experienced operator with M probe., Experienced operator with XL probe.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trained operator with M probe.Device
Trained operator with M probe: non-drug intervention, baseline comparator.
Experienced operator with M probe.Device
Experienced operator with M probe: non-drug intervention, longitudinal comparator.
Experienced operator with XL probe.Device
Experienced operator with XL probe: non-drug intervention, longitudinal comparator.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic liver disease | Not described Receives: Device: Trained operator with M probe.; Device: Experienced operator with M probe.; Device: Experienced operator with XL probe. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Applicability of transient elastography (TE)
Applicability will be calculated as the proportion of reliable liver stiffness measurements (LSM). TE will be considered ADEQUATE when it included at least 10 valid measurements with a success rate ≥60% and interquartile range/median of LSM (IQR/M) ≤30% OR INADEQUATE.
Measured: Will be calculated after evaluation of all included patients with M probe by trained operators (at baseline and after 48 weeks), M probe by experienced operators after 72 weeks and XL probe after 72 weeks.
Secondary outcomes (1)
Diagnostic accuracy of TE
Diagnostic accuracy will be calculated with the number of correctly classified patients (wuth significant fibrosis) considering a cut-off value of 7.6 kPa.
Measured: Will be calculated after evaluation of all included patients with M probe by trained operators after 48 weeks, M probe by experienced operators after 72 weeks and XL probe after 72 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver Diseases (CLD)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 868 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Antonio Carrion, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900808
- Sponsor's protocol ID
- APPLICABILITY- TE
- Status last verified
- Jul 2013
- First submitted
- 12 Jul 2013
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Carrion JA, Puigvehi M, Coll S, Garcia-Retortillo M, Canete N, Fernandez R, Marquez C, Gimenez MD, Garcia M, Bory F, Sola R. Applicability and accuracy improvement of transient elastography using the M and XL probes by experienced operators. J Viral Hepat. 2015 Mar;22(3):297-306. doi: 10.1111/jvh.12296. Epub 2014 Aug 27.
PubMed 25164560
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Transient Elastography Applicability and Diagnostic Accuracy to Identify Significant Fibrosis by Experienced Operators Using the M and XL Probe.
- ClinicalTrials.gov ID
- NCT01900808
- Acronym / sponsor ID
- APPLICABILITY- TE
- Conditions
- Chronic Liver Diseases (CLD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 868 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Jul 2013 (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.
Transient elastography (TE)is the reference method to identify liver stiffness (LSM) but fails to obtain a measurement in 3% of cases and results are considered unreliable in 16%. The aim of this study is to evaluate the applicability and diagnostic accuracy of TE performed by trained operators (<500 explorations), after a second evaluation by experienced explorers (>500 explorations) and after a third exploration using XL probe. Inadequate LSM will be re-evaluated by experienced operators with the M (standard size) probe. A third register will be performed with XL (obese size) probe in those patients with inadequate M probe determination. Diagnostic accuracy will be estimated in patients with liver biopsy to identify significant fibrosis with a TE cut-off value of 7.6 kPa (kilo pascal).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic liver disease | – | Device: Trained operator with M probe., Device: Experienced operator with M probe., Device: Experienced operator with XL probe. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver stiffness
Key inclusion criteria (3 listed)
- Patients with chronic liver disease evaluated with TE by trained operators (experience <500 explorations).
- Signed inform consent.
- Aged between 18-90.
Key exclusion criteria (2 listed)
- Patients with ascites.
- Pregnancy.
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 |
|---|---|---|
| Trained operator with M probe.Trained operator with M probe: non-drug intervention, baseline comparator. | Device | Patients with chronic liver disease |
| Experienced operator with M probe.Experienced operator with M probe: non-drug intervention, longitudinal comparator. | Device | Patients with chronic liver disease |
| Experienced operator with XL probe.Experienced operator with XL probe: non-drug intervention, longitudinal comparator. | Device | Patients with chronic liver disease |
Primary outcome
Applicability of transient elastography (TE)
Time frame: Will be calculated after evaluation of all included patients with M probe by trained operators (at baseline and after 48 weeks), M probe by experienced operators after 72 weeks and XL probe after 72 weeks.
Applicability will be calculated as the proportion of reliable liver stiffness measurements (LSM). TE will be considered ADEQUATE when it included at least 10 valid measurements with a success rate ≥60% and interquartile range/median of LSM (IQR/M) ≤30% OR INADEQUATE.
1 secondary outcome
Diagnostic accuracy of TE
Time frame: Will be calculated after evaluation of all included patients with M probe by trained operators after 48 weeks, M probe by experienced operators after 72 weeks and XL probe after 72 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
- Derived from this study: PubMed 25164560Carrion JA, Puigvehi M, Coll S, Garcia-Retortillo M, Canete N, Fernandez R, Marquez C, Gimenez MD, Garcia M, Bory F, Sola R. Applicability and accuracy improvement of transient elastography using the M and XL probes by experienced operators. J Viral Hepat. 2015 Mar;22(3):297-306. doi: 10.1111/jvh.12296. Epub 2014 Aug 27.
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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?
An observational study of Chronic Liver Diseases (CLD), run by Parc de Salut Mar at 1 site in Spain.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Jan 2016. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Applicability of transient elastography (TE) (time frame: Will be calculated after evaluation of all included patients with M probe by trained operators (at baseline and after 48 weeks), M probe by experienced operators after 72 weeks and XL probe after 72 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01900808, which also lists 1 linked publication.
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 18 Jan 2016; AzTrials last refreshed its copy on 6 Nov 2026.