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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Liver Diseases (CLD)
• Intervention / Treatment: Device: Trained operator with M probe.; Device: Experienced operator with M probe.; Device: Experienced operator with XL probe.

• Study Type: Observational
• Enrollment (Actual): 868

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar, Servei de Digestiu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with liver stiffness

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with chronic liver disease	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Applicability of transient elastography (TE)	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of TE	Diagnostic accuracy will be calculated with the number of correctly classified patients (wuth significant fibrosis) considering a cut-off value of 7.6 kPa.	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.

Collaborators and Investigators

• Sponsor: Parc de Salut Mar

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 12, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimate): July 16, 2013

Study Record Updates

• Last Update Posted (Estimate): January 18, 2016
• Last Update Submitted That Met QC Criteria: January 15, 2016
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: APPLICABILITY- TE