- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03947359
Effect of Thoracic Diameter and Food Intake on Fibroscan® Results (FS)
Effect of Thoracic Diameter and Food Intake on Fibroscan® Results: Comparison of the S - and M-probes
The study aims to deliver scientific data regarding the accuracy of the two different-sized Fibroscan® probes on patients with different thoracic diameter to gain more knowledge of the handling and measuring quality of the Fibroscan® as a diagnostic device and also to see if one probe is enough to measure a wider spectrum of patients leading to cost reduction for equipment such as additional probes.
Furthermore the study aims to analyze the effect of food intake on liver-stiffness measurements with the S-probe on children to shorten fasting periods. It is hypothesized that the fasting periods before a Fibroscan® measurement may be shortened, which is of special importance in smaller children.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Fibroscan® (Echosens, France) is an ultrasound-based, non-invasive and non-painful diagnostic device which also has no complications and can be repeated easily to measure liver-stiffness by transient elastography. The company's device was first released and put on the market in 2003. The device can measure liver stiffness and liver fat content (controlled attenuation parameter CAP).
It is used for the identification and graduation of liver pathologies such as fibrosis and cirrhosis and it can be used on adults and children alike. Therefore patients with chronic liver diseases such as hepatitis C, hepatitis B, alcoholic liver disease as well as metabolic steatohepatitis and different biliary diseases can be examined with it.
Currently the standard procedure for grading fibrosis and cirrhosis still is the liver biopsy, however studies have compared the two procedures in context with different liver conditions like non-alcoholic fatty liver disease or hepatitis C and partially demonstrated that in terms of measuring liver-stiffness the Fibroscan® can rival the liver biopsy.
Usually the Fibroscan® measurements are performed using different probes that vary in frequency and penetration depth depending on the thoracic diameter of the patient. These probes are then applied in an intercostal space on the right side on the level of the liver.
The company Echosens that is producing the currently used model of the Fibroscan® alongside its different-sized probes claims that their S-sized probe is to be used for patients with a thoracic diameter below 75 cm and that their M-sized probe for patients above 75 cm diameter because otherwise the results would not be accurate. The company claims that using the M-sized probe on a patient with a thoracic diameter below 75 cm would cause wrong measurements. However, there is no data or studies that actually have compared the S- and the M- probe to each other and therefore the accuracy of the statement from Echosens is scientifically yet to be confirmed. So far only data on comparison of the M and XL-probe have been published.
Furthermore, food intake seems to impact on Fibroscan® -measurements. It has been already proven in past studies that food intake indeed has an effect on liver-stiffness and therefore influences the quality of Fibroscan® -measurements. All these studies revealed that it is the best to measure the patients while in a fasting condition for several hours. However, these studies all were performed on adults with different kinds of liver-diseases using the M-probe. So far, no data on the impact of food intake on measurements with the S-probe have been published.
Since it is to be expected that because of its attributes transient elastography will gain even more importance as a diagnostic device in the future, it is very significant to produce as much of valid data as possible.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Graz, Austria
- Medical University Graz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Age > 18 for the adult Population
Age 11-18 for the paediatric population
Informed consent
No history of liver disease
Thoracic diameter >45 cm
Exclusion Criteria:
Acute or chronic liver disease
Any other disease or circumstance that may impact on the result of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Participants with a thoracic diameter < 75 cm
Measurement of liver stiffness before and after a standardized meal with different probes
|
Measurement of liver stiffness
Measurement of liver stiffness
|
OTHER: Participants with a thoracic diameter >75 cm
Measurement of liver stiffness before and after a standardized meal with different probes
|
Measurement of liver stiffness
Measurement of liver stiffness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Liver stiffness
Time Frame: baseline
|
Comparison of liver stiffness measurements at baseline with M- and S- probe
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Liver stiffness
Time Frame: 120 minutes
|
Measurement of liver stiffness measurements with M- probe after a standardized meal
|
120 minutes
|
Liver stiffness
Time Frame: 120 minutes
|
Measurement of liver stiffness measurements with S- probe after a standardized meal
|
120 minutes
|
Liver fat content
Time Frame: baseline
|
Controlled attenuation parameter measured with M probe
|
baseline
|
Liver fat content
Time Frame: 120 minutes
|
Controlled attenuation parameter measured with S probe
|
120 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Fibroscan_V1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Stiffness
-
China Medical University HospitalUnknownLiver Fibrosis | Visceral StiffnessTaiwan
-
Calliditas Therapeutics Suisse SAActive, not recruitingPrimary Biliary Cholangitis | Liver StiffnessUnited States, Spain, France, Australia, Israel, Canada, Switzerland, Italy, New Zealand, Germany, Poland, Greece, United Kingdom, Belgium, Austria, Czechia, Hungary, Sweden
-
Chinese University of Hong KongNot yet recruitingArterial Stiffness
-
Riphah International UniversityCompleted
-
International Society for Vascular HealthCompleted
-
National Taiwan University HospitalUnknownMuscle StiffnessTaiwan
-
Mayo ClinicNot yet recruiting
-
WithingsNot yet recruiting
-
Bangkok Metropolitan Administration Medical College...Completed
-
Ospedale Regionale di LocarnoCompletedVascular Stiffness
Clinical Trials on Fibroscan Touch 502 M probe
-
EchosensRecruitingSpleen; FibrosisSpain, Netherlands, Romania
-
Parc de Salut MarCompleted
-
EchosensCompletedObesity, Morbid | Liver FibrosisFrance
-
EchosensCompleted
-
Hospital Vall d'HebronCompletedFibrosis, Liver | Elastography | Chronic Liver Disease | PediatricsSpain
-
European Georges Pompidou HospitalEchosensCompletedObesity | Fibrosis, Liver | Steatosis
-
Saint Clare's Health SystemSaint Clare's FoundationUnknownHip or Knee ReplacementUnited States
-
University of Medicine and Pharmacy CraiovaUnknownGastrointestinal Neoplasms | Gastric Cancer | Colorectal CancerRomania