NCT01900808

Improvement of Transient Elastography Applicability and Diagnostic Accuracy to Identify Significant Fibrosis by Experienced Operators Using the M and XL Probe.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 868 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Liver Diseases (CLD)

Interventions

Type	Name	Description
DEVICE	Trained operator with M probe.	Trained operator with M probe: non-drug intervention, baseline comparator.
DEVICE	Experienced operator with M probe.	Experienced operator with M probe: non-drug intervention, longitudinal comparator.
DEVICE	Experienced operator with XL probe.	Experienced operator with XL probe: non-drug intervention, longitudinal comparator.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-04-01
• Completion: 2012-12-01
• First posted: 2013-07-16
• Last updated: 2016-01-18

Locations

1 site across 1 country: Spain