M116 - Feasibility and performances of spleen stiffness measurement
Research type
Research Study
Full title
M116 - Feasibility and performances of spleen stiffness measurement as surrogate marker for esophageal varices in cirrhotic patients
IRAS ID
177311
Contact name
Massimo Pinzani
Contact email
Sponsor organisation
Echosens
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 12 days
Research summary
FibroScan® 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).
Clinical studies have shown the high accuracy of LSM by FibroScan®, in the estimation of the grade of liver fibrosis or cirrhosis, compared to liver biopsy, in patients affected by chronic hepatitis B and C, in HIV co-infected patients, but also in biliary diseases, alcohol related liver disease or non-alcoholic fatty liver disease.
Some other studies have already shown the good correlation between LSM, assessed by FibroScan®, and the presence of PHT as well as the grade of portal hypertension (PHT) and the presence of oesophageal varices (OV) or large OV and the risk of bleeding. Transient elastography has been considered as an interesting diagnostic tool for the non-invasive evaluation of PHT.
The development of 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, GV for estimating the grade of OV. The other gold standard method to estimate the portal pressure is the measurement of the hepatic vein pressure gradient (HVPG).
However these two methods are quite invasive and associated with some risks. Consequently the aim of this study is the validation of spleen stiffness measurement SSM, assessed by a FibroScan® with acquisition parameters and algorithm optimized for SSM, as surrogate non-invasive marker for the presence of OV in liver cirrhosis patients. At the same time, its correlation with HVPG measurement will be evaluated and it will be compared to other validated non-invasive approaches, in order to create a non-invasive diagnostic work up, to select patients for endoscopic screening.
REC name
London - Fulham Research Ethics Committee
REC reference
15/LO/0676
Date of REC Opinion
17 Jun 2015
REC opinion
Further Information Unfavourable Opinion