Agreement and Reliability of Transient Elastography
HEPSCAN
1 other identifier
observational
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2022
CompletedFirst Posted
Study publicly available on registry
January 17, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedOctober 4, 2023
October 1, 2023
2.7 years
December 7, 2022
October 2, 2023
Conditions
Outcome Measures
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).
Assessed at a 30 min visit to the outpatient clinic
Secondary Outcomes (2)
Reliability, estimated using the intra-class correlation
Assessed at a 30 min visit to the outpatient clinic
Patient and exam characteristics associated with inter-rater differences above our prespecefied threshold.
Assessed at a 30 min visit to the outpatient clinic
Study Arms (1)
Chronic viral hepatitis
Interventions
Transient elastography measures liver stiffness in kPa
Eligibility Criteria
Patients with chronic viral hepatitis, i.e. chronic hepatitis B (with or without chronic hepatitis D), of chronic hepatitis C.
You may qualify if:
- 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.
You may not qualify if:
- suspected or confirmed pregnancy.
- patients unable to speak Swedish
- inability to sign informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
Study Sites (1)
Oskar Ljungquist
Helsingborg, Skåne County, 25187, Sweden
Study Officials
- PRINCIPAL INVESTIGATOR
Oskar Ljungquist, MD, PhD.
Division of Infection Medicine, Department of Clinical Sciences, Lund University, Lund.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2022
First Posted
January 17, 2023
Study Start
June 1, 2023
Primary Completion
February 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
October 4, 2023
Record last verified: 2023-10