Optimization of spleen VCTE examinations with FibroScan

Chronic Liver Diseases (CLDs) are usually asymptomatic, progressive, and
ultimately potentially fatal diseases. Cirrhosis is the end stage of all CLDs
and the principal complication is the portal hypertension (PH) which is the
result of congestion within the liver that causes an impaired blood flow from
the portal vein to the hepatic vein. The gold standard for diagnosing PH is by
measuring the Hepatic Venus Pressure Gradient (HVPG), PH is defined as a HVPG >
6 mm Hg and it will be considered as clinically significant (CSPH) when it is
HVPG > 10 mm Hg. The HVPG values correlate with the risk of esophageal varices
(EV) development and clinical decompensation when >= 10 mmHg, and with the risk
of variceal bleeding when >= 12 mmHg. However, this method is invasive, costly
and it is only available in specialized centers.

PH may have different consequences such as hepatocellular carcinoma (HCC),
ascites, esophageal/gastric varices, and hepatic encephalopathy.
The development of EV in cirrhotic patients, as well as their potential
bleeding, represent one of the most severe and life-threatening complications
of cirrhosis. The prevalence of EV among cirrhotic patients is about 50-60%,
with an incidence of variceal bleeding of approximatively 5% to 15% yearly, and
a variceal re-bleeding rate of 30% to 40% within the first 6 weeks.
Furthermore, gastro intestinal variceal bleeding is associated with
significant mortality up to 30% in adults and between 0-15% in children. Upper
gastrointestinal endoscopy (EGD) is the reference diagnostic tool for detecting
the presence of EV, for estimating their grade and for the recognition of
indicators of high-bleeding risk EV (HRV) but this method, as
for HVPG, is invasive and costly.

Therefore, several non-invasive methods (serum biomarkers and elastography
techniques) have been proposed to predict the degree of PH and the presence of
EV.
In this context, in 2019, Echosens has developed a new FibroScan device
intended to provide Spleen Stiffness Measurement (SSM)8 . A European
multicenter study was conducted with 260 patients included (Stefanescu et al,
2019). It has shown an excellent applicability rate of the SSM@100 Hz (88%) and
a diagnostic accuracy of SSM@100Hz for EV, large EV and HRV presence higher
than in most non-invasive test (NITs). In addition, it
reports that the combination of Baveno VI criteria with SSM@100Hz for the
diagnosis of HVR led to a spared EGD rate of 38.9%, without missing more than
5% of HRV, compared to Baveno VI criteria alone, having a spared EGD rate of
8.1%. This study has shown that the SSM is a non-invasive diagnostic tool
useful to select patients at high risk for EV and PH, which could be later
addressed to more invasive diagnostic investigations, such as EGD and HVPG
measurement and to select patients for endoscopic screening of HRV. Finally, in
the most recent EASL guidelines, the SSM is recommended as an additional NIT to
further improve risk stratification and refine the risk of HRV.

However, NAFLD and obese patients were excluded from this study in order to
work in the best standardized conditions. Then, with the NAFLD emergence
worldwide, it appears to be needed to develop a probe dedicated to overweight
and obese patients.
Consequently, the aim of this study is to develop the spleen examination
measurement by FibroScan® for overweight or obese patients.

Main objective : To develop a spleen examination dedicated to overweight or
obese patients and assessits applicability.

Secondary objectives :
1. Develop a spleen exam dedicated to patients usually measured with the S+
probe and assess its applicability.
2. Optimize the available spleen exam dedicated to patients measured with the
M+ probe and assess its applicability.
3. Develop a spleen targeting tool (STT) and a measurement mode with automatic
adaptation of depths (according to the patient's morphology) for the S+, M+ and
XL+ spleen exams improving the applicability.

European, prospective, interventional, multicentre clinical investigation.

The additional constraint of the participation in this study is related to the
condition of the examination, which is to be fasting for at least 3 hours
before the FibroScan exam.

The risk to the use of the FibroScan is insignificant: no serious or
non-serious adverse events have been reported since 2003. The FibroScan uses
non-invasive and painless techniques, which is particularly adapted for early
detection of chronic liver disease. The FibroScan is used in more than 80
countries around the world.

The adjustments made to the research device aim to collect the necessary
information to develop the spleen examination of the FibroScan with the S+ and
XL+ probes and to optimize the spleen examination with M+ probes. Patient
participation will help researchers achieve the goals of this study with
important new data to build and improve FibroScan® for spleen studies in more
patients

In addition, developing such examination for overweight and obese patients as
well as for children will give them the access to this non-invasive diagnostic
technique detecting advanced chronic liver diseases.