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

Chronic Liver Diseases (CLD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900808
• Other study ID #: APPLICABILITY- TE
• Status: Completed
• Phase: N/A
• First received: July 12, 2013
• Last updated: January 15, 2016
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 868
• Est. completion date: December 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Liver Diseases (CLD)
• Liver Diseases

Intervention

Device:
• Trained operator with M probe.
Trained operator with M probe: non-drug intervention, baseline comparator.
• Experienced operator with M probe.
Experienced operator with M probe: non-drug intervention, longitudinal comparator.
• Experienced operator with XL probe.
Experienced operator with XL probe: non-drug intervention, longitudinal comparator.

Locations

Country	Name	City	State
Spain	Hospital del Mar, Servei de Digestiu	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No