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

Completed

• Conditions: Chronic Liver Diseases (CLD)

• Registration Number: NCT01900808
• Lead Sponsor: Parc de Salut Mar

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-04
• Study Completion: 2012-12
• Status Verified: 2013-07
• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-16
• Last Update Submitted: 2016-01-15
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 868

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital del Mar, Servei de Digestiu; 🇪🇸 Barcelona, Spain