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

NCT ID: NCT01900808

Last Updated: 2016-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 868 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-12-31

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).

Conditions

Chronic Liver Diseases (CLD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with chronic liver disease

Trained operator with M probe.

Intervention Type: DEVICE

Trained operator with M probe: non-drug intervention, baseline comparator.

Experienced operator with M probe.

Intervention Type: DEVICE

Experienced operator with M probe: non-drug intervention, longitudinal comparator.

Experienced operator with XL probe.

Intervention Type: DEVICE

Experienced operator with XL probe: non-drug intervention, longitudinal comparator.

Interventions

Trained operator with M probe.

Trained operator with M probe: non-drug intervention, baseline comparator.

Intervention Type: DEVICE

Experienced operator with M probe.

Experienced operator with M probe: non-drug intervention, longitudinal comparator.

Intervention Type: DEVICE

Experienced operator with XL probe.

Experienced operator with XL probe: non-drug intervention, longitudinal comparator.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

José Antonio Carrion

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital del Mar, Servei de Digestiu

Barcelona, Barcelona, Spain

Countries

Spain

References

Carrion JA, Puigvehi M, Coll S, Garcia-Retortillo M, Canete N, Fernandez R, Marquez C, Gimenez MD, Garcia M, Bory F, Sola R. Applicability and accuracy improvement of transient elastography using the M and XL probes by experienced operators. J Viral Hepat. 2015 Mar;22(3):297-306. doi: 10.1111/jvh.12296. Epub 2014 Aug 27.

Reference Type: DERIVED

PMID: 25164560 (View on PubMed)

Other Identifiers

APPLICABILITY- TE

Identifier Type: -

Identifier Source: org_study_id