Spleen Stiffness Measurement With FibroScan

Summary

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.

Conditions

• Cirrhosis

Interventions

DEVICE

Fibroscan® examination

Each patient undergo 1 LSM and at least 1 SSM (2 in more if the patient accept to participate at the ancillary study (intra and inter operator reproducibility of SSM).

Sponsors & Collaborators

• Echosens

  lead INDUSTRY

Principal Investigators

• Davide FESTI, Pr. · Department of Clinical Medicine, Policlinico S. Orsola Malpighi, Bologna, Italy

• Horia STEFANESCU, Dr. · Iuliu Hatieganu University of Medicine and Pharmacy, Clu-Napoca, Romania

• Victor de LEDINGHEN, Pr. · Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive, Pessac, France

• Paul CALES, Pr. · CHU, Service Hépato-gastroentérologie, Angers, France

• Mirella FRAQUELLI, Dr. · Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milano, Italy

• Nathalie CARRIE-GANNE, Pr. · Hôpital Jean Verdier, Service Hépato-gastroentérologie, Bondy, France

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2017-01-31

Completion

2017-06-30

Countries

• France
• Italy
• Romania
• United Kingdom

Study Locations