Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03947359 |
| Other study ID # |
Fibroscan_V1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
Medical University of Graz |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
