Chronic Liver Diseases (CLD)
Conditions
Brief 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%. 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).
Interventions
DEVICETrained operator with M probe.
Trained operator with M probe: non-drug intervention, baseline comparator.
DEVICEExperienced operator with M probe.
Experienced operator with M probe: non-drug intervention, longitudinal comparator.
DEVICEExperienced operator with XL probe.
Experienced operator with XL probe: non-drug intervention, longitudinal comparator.
Sponsors
Parc de Salut Mar
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with chronic liver disease evaluated with TE by trained operators (experience \<500 explorations). * Signed inform consent. * Aged between 18-90.
Exclusion criteria
* Patients with ascites. * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Applicability of transient elastography (TE) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of TE | 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. | Diagnostic accuracy will be calculated with the number of correctly classified patients (wuth significant fibrosis) considering a cut-off value of 7.6 kPa. |
Countries
Spain
Outcome results
None listed