Agreement and Reliability of Transient Elastography
ConditionChronic Viral Hepatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLund University
About this trial
The aim of this study is to assess agreement, smallest detectable change, and reliability of repeated measurements of liver stiffness of transient elastography in patients with chronic viral hepatitis, and to explore factors associated with disagreement.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients at the departments of infectious diseases in Malmö, Lund and Helsingborg with chronic viral hepatitis.
Adult patients
Signed informed consent to participate in the study.
Disqualifiers
suspected or confirmed pregnancy.
patients unable to speak Swedish
inability to sign informed consent.
Trial population
Patients with chronic viral hepatitis, i.e. chronic hepatitis B (with or without chronic hepatitis D), of chronic hepatitis C.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Transient elastography
Diagnostic testTransient elastography measures liver stiffness in kPa
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Chronic viral hepatitis1 intervention
Trial outcomes
Primary outcomes
1
Disagreement defined as a difference in TE results between operators in KPa of ≥ 33%, as well as the smallest detectable change, SDC95.
Disagreement, expressed as 1) the proportion of participants with inter-rater differences at or above our prespecified threshold (33%) and 2) the smallest detectable change, representing the difference needed to state with 95% certainty that a change had occurred in the underlying fibrosis (SDC95).
Time frame
Assessed at a 30 min visit to the outpatient clinicSecondary outcomes
1
Reliability, estimated using the intra-class correlation
Reliability, for continuous stiffness measurements as well as for different fibrosis stage categories.
Time frame
Assessed at a 30 min visit to the outpatient clinic2
Patient and exam characteristics associated with inter-rater differences above our prespecefied threshold.
As an exploratory outcome, patient and exam characteristics associated with inter-rater differences above our prespecified threshold of ≥ 33% in liver stiffness will be evaluated. These characteristics include patients age, hepatitis b staging, BMI, biomarkers including Alanine transaminase, probe type, (medium or XL-probe) viral load, alkaline phosphatase, bilirubin, albumin, prothrombin time/international normalized ratio, time since food (hours), time since alcohol (hours), previous liver biopsy (years)
Time frame
Assessed at a 30 min visit to the outpatient clinicSponsors and contacts
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Source ClinicalTrials.gov