Cirrhosis Clinical Trial
Official title:
Feasibility and Performances of Spleen Stiffness Measurement as Surrogate Marker for Oesophageal Varices in Cirrhotic Patients.
FibroScan® (Echosens, Paris, France) is an active non implantable medical device marketed in
Europe since December 2003 and is currently used in many countries. FibroScan® is an
ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to
liver stiffness measurement (LSM).
Several clinical studies have shown the accuracy of LSM by FibroScan® to predict liver
fibrosis.
Some other studies have already shown the good correlation between LSM, assessed by
FibroScan® based on VCTE™ technology, and the presence of portal hypertension (PHT).
PHT is a clinical condition characterized by a high blood pressure in the portal vein and its
tributaries and it is defined as a gradient between portal and systemic blood pressure > 6
mmHg.
The development of oesophageal varices (OV) in cirrhotic patients, as well as their potential
bleeding, represent one of the most severe and life-threatening complication of cirrhosis.
Upper endoscopy is the best diagnostic tool for detecting the presence of OV, gastric varices
or congestive gastropathy, for estimating the grade of OV and for the recognition of the
presence of red color signs and wale marks or other indicators of high risk for bleeding.
However these two methods are quite invasive and associated with some risks; at the same
time, not all cirrhotic patients present OV at endoscopic screening.
The aim of this study is the validation of SSM, assessed by a FibroScan® with acquisition
parameters and algorithm optimized for SSM, as surrogate noninvasive marker for the presence
of OV in liver cirrhosis patients.
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