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

NCT01900808 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 868

Last updated 2016-01-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-04-30
Completion
2012-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01900808 on ClinicalTrials.gov