Agreement and Reliability of Transient Elastography (HEPSCAN)

Agreement and Reliability of Transient Elastography in Patients With Chronic Viral Hepatitis - a Cross-sectional Test-retest Study

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Viral Hepatitis
• Intervention / Treatment: Diagnostic test: Transient elastography

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Gustav Torisson, M.D, PhD; Phone Number: +464033 10 00; Email: gustav.torisson@med.lu.se
• Study Contact Backup: Name: Oskar Ljungquist, M.D, PhD; Phone Number: +46424061000; Email: oskar.ljungquist@med.lu.se

Study Locations

• Sweden
  • Skåne
    • Helsingborg, Skåne, Sweden, 25187
      • Recruiting
      • Oskar Ljungquist
      • Contact: Oskar Ljungquist; Phone Number: +464061000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic viral hepatitis, i.e. chronic hepatitis B (with or without chronic hepatitis D), of chronic hepatitis C.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic viral hepatitis	Diagnostic test: Transient elastography; Transient elastography measures liver stiffness in kPa; Other Names: Fibroscan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability, estimated using the intra-class correlation	Reliability, for continuous stiffness measurements as well as for different fibrosis stage categories.	Assessed at a 30 min visit to the outpatient clinic
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)	Assessed at a 30 min visit to the outpatient clinic

Collaborators and Investigators

• Sponsor: Lund University
• Investigators: Principal Investigator: Oskar Ljungquist, MD, PhD., Division of Infection Medicine, Department of Clinical Sciences, Lund University, Lund.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hepatitis
• Other Study ID Numbers: CIV-22-08-040567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No