Assessing liver stiffness measurements in chronic viral hepatitis patients
Agreement and Reliability of Transient Elastography in Patients With Chronic Viral Hepatitis - a Cross-sectional Test-retest Study
This study is testing how reliable and consistent liver stiffness measurements are in people with chronic viral hepatitis using a special ultrasound technique.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lund University Academic / other |
| Locations | 1 site (Helsingborg, Skåne County) |
| Trial ID | NCT05686785 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the agreement, smallest detectable change, and reliability of repeated liver stiffness measurements using transient elastography in patients with chronic viral hepatitis. It will explore factors that may contribute to discrepancies in measurements. By focusing on the reliability and agreement metrics, the study seeks to provide a clearer understanding of how transient elastography performs in this patient population, which has not been thoroughly addressed in previous research.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients with chronic viral hepatitis who can provide informed consent and communicate in Swedish.
Not a fit: Patients who are pregnant, unable to speak Swedish, or cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and reliability of liver stiffness assessments, leading to better management of chronic viral hepatitis.
How similar studies have performed: Previous studies have shown excellent test-retest reliability for transient elastography in viral hepatitis, but this study addresses gaps in agreement metrics and smallest detectable change, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Helsingborg, Skåne County
- Oskar Ljungquist — Helsingborg, Skåne County, Sweden (Recruiting)
Study contacts
- Principal investigator: Oskar Ljungquist, MD, PhD. — Division of Infection Medicine, Department of Clinical Sciences, Lund University, Lund.
- Study coordinator: Oskar Ljungquist, M.D, PhD
- Email: oskar.ljungquist@med.lu.se
- Phone: +46424061000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.