No registrations found.
ID
Source
Brief title
Health condition
Non-Alcoholic Steatohepatitis (NASH), Non-Alcoholic Fatty Liver Disease (NAFLD), Obesity, Paediatrics, Hepatic Steatosis, FibroScan, 1H-MR Spectroscopy Proton Density Fat Fraction (MRS-PDFF)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic accuracies of CAP and US for the detection of hepatic steatosis using 1H-MR Spectroscopy derived proton density fat fraction (MRS-PDFF) as reference standard.
Secondary outcome
1. Inter- and intraobserver variability for CAP-values;
2. Success rate of CAP-measurements;
3. Correlation between CAP-values and fat percentage at MRI-based liver fatmaps.
Background summary
CAPped is a study that compares the diagnostic accuracy of the controlled attenuation parameter (CAP) and ultrasonography (US) to detect hepatic steatosis in an overweight or obese paediatric population in the Netherlands using MRI-determined liver fat fractions as reference standard. Sixty subjects will be included and receive CAP, US and a MRI-scan, preferably on one day. All subjects are recruited in the Netherlands (with all study procedures performed in a single centre).
Study objective
Hepatic steatosis is becoming a large health burden in both Western and non-Western societies. In children, the trend of increasing obesity means more and more children are at risk of developing liver steatosis. As liver steatosis is a risk factor in the development of diabetes mellitus type 2 and cardio-vascular disease, there is a need for specific diagnostic tools that can identify the children with liver steatosis and if possible, quantify the amount of steatosis. Quantification will help clinicians to guide therapy. Several tools exist, such as ultrasonography (US), CT, serum test panels, MR Imaging, 1H-MR Spectroscopy and liver biopsy. However, all suffer from shortcomings. A new tool for quantifying steatosis is the Controlled Attenuation Parameter (CAP), available on the FibroScan (a device used to determine the presence of liver fibrosis). This tool has been investigated in adults thus far and has only been compared to the results of liver biopsy, a semi-quantitative score. In this study we will investigate our hypothesis that the Fibroscan/CAP can be used in obese children to identify those with steatosis and obtain a quantitative measure of the amount of liver fat and that its diagnostic accuracy is higher than of US.
Study design
1. CAP-value measured with FibroScan device (at least once by examiner 1, time and schedule permitting twice by a second examiner), US and (availability pertaining) MRI at visit 1.
2. Depending on scanner availability, MRI was performed on a second visit in short proximity to visit 1.
Intervention
N/A
Jurgen Runge
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
j.h.runge@amsterdamumc.nl
Jurgen Runge
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
j.h.runge@amsterdamumc.nl
Inclusion criteria
- Written informed consent from parent(s) and subject (when >12 years of age)
- For current patients:
• Clinically suspected or high risk profile of hepatic steatosis based on at least one of the following:
- abnormal echogenicity of liver in ultrasonography;
- elevated serum transaminases levels;
- high BMI (>+3 z-score) and/or waist circumference (>95 percentile);
- insulin resistance.
- For patients no longer in active follow-up:
• Liver steatosis detected during follow-up in this clinic in the last 3 years
Exclusion criteria
- Age <8 and >18 years
- The need for anaesthesia during the MRI examination.
- General contra-indications for MRI scanning (use of MRI checklist, see document E4)
- Known focal liver lesion(s) in the right liver lobe (proven with histology results or imaging)
- Known concomitant liver disorders
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4155 |
| NTR-old | NTR4345 |
| CCMO | NL47936.018.14 |
| OMON | NL-OMON44182 |