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OpenTrials
Completed

NCT Number: NCT01900808

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).

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Key information

Conditions

Chronic Liver Diseases (CLD)

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital del Mar, Servei de Digestiu

Barcelona, 08003, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trained operator with M probe.

Device

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

Experienced operator with M probe.

Device

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

Experienced operator with XL probe.

Device

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

Primary outcomes

  1. Applicability of transient elastography (TE)

    Time frame: 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.

    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.

Secondary outcomes

  1. Diagnostic accuracy of TE

    Time frame: 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.

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

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 16, 2013
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.