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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic liver disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trained operator with M probe. | Device | Trained operator with M probe: non-drug intervention, baseline comparator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with liver stiffness
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar, Servei de Digestiu | Barcelona | Barcelona | 08003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25164560 | Derived | 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. |
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| 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. |
|