An observational study in Chronic Liver Diseases (CLD), sponsored by Parc de Salut Mar. Completed at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-01-18.
Sponsored by Parc de Salut Mar · Observational
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).
2,080 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.
This study's enrollment of 868 is above the median of 167 across 681 observational studies indexed under Liver Diseases.
Browse Liver Diseases studies →Parc de Salut Mar is the lead sponsor of 180 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with liver stiffness
Exclusion Criteria:
Device: Trained operator with M probe. · Device: Experienced operator with M probe. · Device: Experienced operator with XL probe.
Trained operator with M probe: non-drug intervention, baseline comparator.
Experienced operator with M probe: non-drug intervention, longitudinal comparator.
Experienced operator with XL probe: non-drug intervention, longitudinal comparator.
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.
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.
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.
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.
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Parc de Salut Mar