Use of Shear Wave Elastography to Assess Non-alcoholic Fatty Liver Disease (NAFLD)

NCT ID: NCT03587298

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-15
• Study Completion Date: 2021-08-31

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.

Detailed Description

NAFLD (non-alcoholic fatty liver disease) is by far the most common form of chronic liver disease worldwide. It is estimated that it affects up to 1/3 of the adult population in industrialized countries and additionally more and more children are affected. The term NAFLD covers a broad spectrum of diseases ranging from simple hepatic steatosis (accumulation of fat in hepatocytes) to NASH (non-alcoholic steatohepatitis). The latter is a progression of liver steatosis with inflammation, fibrosis and chronic inflammatory structural changes. Up to 20% of a NASH develops liver cirrhosis, more rarely also a hepatocellular carcinoma.

It is known that the degree of fibrosis is the most important parameter for the clinical course and prognosis. In addition, patients with mild lobular inflammation or fibrosis (regardless of severity) have an increased risk of developing NASH compared to patients with exclusive steatosis. A significant number of patients with NAFL may develop fibrotising NASH (5-20%). This is particularly the case when metabolic factors continue to deteriorate.

Liver biopsy remains the gold standard for the diagnosis of NAFLD. In particular, differentiation between NAFL and NASH and the degree of fibrosis are still only possible using histology. The invasive nature of the procedure involves risks to the patient's health such as bleeding, injuries to other organs or nerves, and complications of anesthesia. Furthermore, since the biopsy is taken selectively as a liver biopsy, it is possible to test a sample that does not adequately represent the degree of actual fibrosis, since regional differences in the severity of liver fibrosis can often be present. In addition, the liver biopsy is associated with considerable costs. Accordingly, liver biopsy is not an optimal diagnostic procedure and is hardly suitable as a diagnostic method for short-term follow-up under therapy. For this reason, a reliable, non-invasive method has long been sought to diagnose NAFLD, to distinguish NASH from steatosis, to assess the degree of fibrosis and which allows a less stressful assessment of the course of the liver.

Imaging procedures are available here. B-image sonography is already routinely used in children and adolescents with suspected or proven NASH for the detection of liver remodeling processes, in particular fibrosis. B-scan sonography is an excellent method for determining the presence and extent of hepatic steatosis, but the detection and graduation of liver fibrosis using B-mode sonography is only possible in very advanced stages.

In recent years, the determination of tissue stiffness in various organ systems and their pathologies, such as the breast, tendons and liver, has been successfully used in adults. Individual reports in adults give first indications that liver remodelling processes, in particular fibrosis by means of shear wave elastography (SWE), can be diagnosed in early stages. However, the evidence of the use of SWE in children to assess liver parenchyma changes, especially in NAFLD, is still insufficient. Therefore, in this study it will be investigated whether the rt-SWE provides reproducible values for liver stiffness and fibrosis in children and adolescents and by that a reliably diagnosis of NAFLD and assessment of the degree of fibrosis is possible.

The planned clinical examination and blood collection for laboratory chemical examinations are part of the routine follow-up of patients with obesity and steatosis hepatis. There will be no additional examinations, so there will be no greater burden on the young patients and no additional time expenditure.

Conditions

NAFLD

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

NAFLK criteria met (by definition: sonographic fatty liver)

Real-Time (Supersonic)- 2D shear wave elastography (rt-SWE)

Intervention Type: PROCEDURE

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.

Group 2

Control group: matched age; no NAFKL

Real-Time (Supersonic)- 2D shear wave elastography (rt-SWE)

Intervention Type: PROCEDURE

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.

Interventions

Real-Time (Supersonic)- 2D shear wave elastography (rt-SWE)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angeliki Pappas, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Paediatric Clinic; RWTH Aachen University Hospital

Locations

Paediatric Clini; RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Angeliki Pappas, Dr. med.

Role: CONTACT

apappa@ukaachen.de

0241 80-89206

Evangelia-Vera Papagrigoraki

Role: CONTACT

epapagrigora@ukaachen.de

Other Identifiers

18-056

Identifier Type: -

Identifier Source: org_study_id