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

Parc de Salut Mar

Status: Completed

Conditions: Chronic Liver Diseases (CLD)

Treatments: Device: Trained operator with M probe.; Device: Experienced operator with M probe.; Device: Experienced operator with XL probe.

Study type: Observational

Funder types: Other

Identifiers

NCT01900808

APPLICABILITY- TE

Details and patient eligibility

About

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).

Enrollment: 868 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

868 participants in 1 patient group

Patients with chronic liver disease

Treatment:

Device: Experienced operator with XL probe.

Device: Trained operator with M probe.

Device: Experienced operator with M probe.