Use of Shear Wave Elastography to Assess Non-alcoholic Fatty Liver Disease (NAFLD)
NAFLD
1 other identifier
observational
80
1 country
1
Brief Summary
The aim of this study is to test a non-invasive imaging technique to reliably diagnose NAFLD in children and adolescents with obesity and assess the degree of fibrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
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
July 2, 2018
CompletedFirst Posted
Study publicly available on registry
July 16, 2018
CompletedStudy Start
First participant enrolled
September 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedMarch 10, 2021
March 1, 2021
2.8 years
July 2, 2018
March 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess non-alcoholic fatty liver disease in adolescents and children with obesity by use of shear wave elastography
stiffness (in kilopascals) of the liver measured with real-time shear wave elastography (RT-SWE) and hence regarding the amount of fibrosis in chronic liver disease
12 month
Study Arms (2)
Group 1
NAFLK criteria met (by definition: sonographic fatty liver)
Group 2
Control group: matched age; no NAFKL
Interventions
The SWE is carried out intercostally. If possible, the patient should hold the breath for 5-10 seconds. So-called colour charts are used, which indicate the derived liver stiffness in colour-coded form. In addition to the visual assessment of these colour charts, the quantitative ROI-based measurement of the SWE in kPa is performed in the "hardest" appearing areas. The measurement is performed at 5 different sites of the liver parenchyma and all SWE values are recorded.
Eligibility Criteria
The patient group is recruited from the obesity consultation hour as well as the emergency consultation hour and the wards of the Clinic for Paediatrics and Youth Medicine at the University Hospital Aachen. The control group is recruited from the group of outpatients and inpatients receiving abdominal sonography from another indication and show no sonographic or laboratory chemical evidence of NAFLD. Patients in the control group are evaluated once.
You may qualify if:
- male and male children and adolescents aged 6-18 years
- obesity with a BMI above percentile 95 according to Kromeyer-Hauschild
- NAFLD criteria met (by definition: sonographic fatty liver)
- written informed consent
- patients of matching age are included in the control group without any indication of NAFLD
You may not qualify if:
- other chronic liver diseases
- alcohol consumption (more than 20g for girls and 30g for boys per day), after explicit anamnesis
- persons who are accommodated in an institution by court or official order
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Paediatric Clini; RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52074, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angeliki Pappas, Dr. med.
Paediatric Clinic; RWTH Aachen University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2018
First Posted
July 16, 2018
Study Start
September 15, 2018
Primary Completion
July 1, 2021
Study Completion
August 1, 2021
Last Updated
March 10, 2021
Record last verified: 2021-03