Oskar Ljungquist
Helsingborg, Skåne County, 25187, Sweden
Location status: Recruiting
Recruiting
NCT Number: NCT05686785
Agreement and Reliability of Transient Elastography
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
Previous studies have reported excellent test-retest reliability for transient elastography (TE) in viral hepatitis. Reliability refers the ability of an instrument to discriminate between study subjects and may be excellent even if considerable measurement-error exists, if the population is heterogenous. Agreement, in contrast, refers to differences of measurements on the original scale (kPa for TE). Whether agreement is acceptable is situation-dependent and can be related to the smallest detectable change (SDC).
Agreement metrics or SDC have not been addressed in previous studies for chronic viral hepatitis. The aim of this study is to assess agreement, SDC, and reliability of repeated measurements of liver stiffness of TE in patients with chronic viral hepatitis, and to explore factors associated with disagreement.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- suspected or confirmed pregnancy.
- patients unable to speak Swedish
- inability to sign informed consent.
Treatment and study plan
Transient elastography
Diagnostic TestTransient elastography measures liver stiffness in kPa
Other names: Fibroscan
Primary outcomes
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Disagreement defined as a difference in TE results between operators in KPa of ≥ 33%, as well as the smallest detectable change, SDC95.
Time frame: Assessed at a 30 min visit to the outpatient clinic
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).
Secondary outcomes
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Reliability, estimated using the intra-class correlation
Time frame: Assessed at a 30 min visit to the outpatient clinic
Reliability, for continuous stiffness measurements as well as for different fibrosis stage categories.
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Patient and exam characteristics associated with inter-rater differences above our prespecefied threshold.
Time frame: Assessed at a 30 min visit to the outpatient clinic
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)
Study contacts
Contact information is provided by the study sponsor or research team.
Gustav Torisson, M.D, PhD
CONTACT
Oskar Ljungquist, M.D, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Lund University
Other
Registry information
Official study title
Agreement and Reliability of Transient Elastography in Patients With Chronic Viral Hepatitis - a Cross-sectional Test-retest Study
Acronym: HEPSCAN
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jan 17, 2023
- Registry last updated
- Oct 4, 2023
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.
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