NAFLDNAFLDNCT03587298
Use of Shear Wave Elastography to Assess Non-alcoholic Fatty Liver Disease (NAFLD)
An observational study of NAFLD, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD
- What is being tested?
- Real-Time (Supersonic)- 2D shear wave elastography (rt-SWE)
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 15 Sep 2018to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Evangelia-Vera Papagrigoraki contact
Germany1 site, 1 recruiting
- Recruiting
Paediatric Clini; RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Use of Shear Wave Elastography in Adolescents and Children With Obesity to Assess Non-alcoholic Fatty Liver Disease (NAFLD)
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.
Read the 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
- Being tested
- Real-Time (Supersonic)- 2D shear wave elastography (rt-SWE)
- Keywords
- ShearWave Elastography
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time (Supersonic)- 2D shear wave elastography (rt-SWE)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | NAFLK criteria met (by definition: sonographic fatty liver) Receives: Procedure: Real-Time (Supersonic)- 2D shear wave elastography (rt-SWE) | |
| Group 2 | Control group: matched age; no NAFKL Receives: Procedure: Real-Time (Supersonic)- 2D shear wave elastography (rt-SWE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start15 Sep 2018
- Primary completionJul 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angeliki Pappas, Dr. med., Principal investigator, Paediatric Clinic; RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587298
- Sponsor's protocol ID
- 18-056
- Acronym
- NAFLD
- Status last verified
- Mar 2021
- First submitted
- 2 Jul 2018
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Shear Wave Elastography in Adolescents and Children With Obesity to Assess Non-alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT03587298
- Acronym / sponsor ID
- NAFLD / 18-056
- Conditions
- NAFLD
- Keywords
- ShearWave Elastography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 16 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Real-Time (Supersonic)- 2D shear wave elastography (rt-SWE)NAFLK criteria met (by definition: sonographic fatty liver) |
| Group 2 | – | Procedure: Real-Time (Supersonic)- 2D shear wave elastography (rt-SWE)Control group: matched age; no NAFKL |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Assess non-alcoholic fatty liver disease in adolescents and children with obesity by use of shear wave elastography
Time frame: 12 month
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evangelia-Vera Papagrigoraki contact
Angeliki Pappas, Dr. med. principal investigator
Paediatric Clinic; RWTH Aachen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angeliki Pappas, Dr. med. (0241 80-89206, apappa@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess non-alcoholic fatty liver disease in adolescents and children with obesity by use of shear wave elastography (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.