Study Results
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Basic Information
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COMPLETED
NA
403 participants
INTERVENTIONAL
2012-03-31
2017-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Fibroscan®
Fibroscan® is an active non implantable medical device using ultrasound. It has been designed to measure liver stiffness in a painless, rapid and non invasive manner. It is a diagnostic aid tool. In this study, Spleen Stiffness Measurement will be assessed using a dedicated FibroScan® device which has been developed specifically to assess spleen stiffness.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Both gender, 18-79 years old
* Patient able to give written informed consent form
* Patient affiliated to a social security system.
* Case group
* Patient with chronic liver disease due to: hepatitis C virus, hepatitis B virus or Alcoholic Liver Disease and liver stiffness ≥ 14 kPa
* Patient with the following examination within 3 months of LSM and SSM: ultrasound examination, blood examination, gastroscopy examination and eventually an hepatic venous pressure gradient examination
* Control groups
* Patient with chronic liver disease due to: HCV, HBV or Alcoholic Liver Disease and liver stiffness \< 14 kPa
* Patients without chronic liver disease (Healthy Control subgroup)
Exclusion Criteria
* Consuming illness (HIV infection, malignancy).
* Associated comorbidities: NASH, hemochromatosis, primary sclerosing cholangitis, primary biliary cirrhosis.
* Antiviral treatment during the two months before inclusion.
* Pacemaker or heart defibrillator.
* Pregnancy.
* Liver transplantation.
* BMI\>35 kg/m2.
* Serum Transaminases \> 250 IU/L.
* History of / or current βblockers treatment of OV.
* Presence of ascites.
* Previous endoscopic treatment of OV.
* Patient with acute alcoholic hepatitis and associated jaundice (generally defined by total bilirubin ≥ 50 µmol/l).
* Patient with hepatocellular carcinoma (HCC).
* Unable or unwilling to undergo a liver stiffness measurement, a spleen stiffness measurement, an ultrasound examination, a blood examination or a gastroscopy examination.
18 Years
79 Years
ALL
Yes
Sponsors
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Echosens
INDUSTRY
Responsible Party
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Principal Investigators
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Davide FESTI, Pr.
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Medicine, Policlinico S. Orsola Malpighi, Bologna, Italy
Horia STEFANESCU, Dr.
Role: PRINCIPAL_INVESTIGATOR
Iuliu Hatieganu University of Medicine and Pharmacy, Clu-Napoca, Romania
Victor de LEDINGHEN, Pr.
Role: PRINCIPAL_INVESTIGATOR
Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive, Pessac, France
Paul CALES, Pr.
Role: PRINCIPAL_INVESTIGATOR
CHU, Service Hépato-gastroentérologie, Angers, France
Mirella FRAQUELLI, Dr.
Role: PRINCIPAL_INVESTIGATOR
Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milano, Italy
Nathalie CARRIE-GANNE, Pr.
Role: PRINCIPAL_INVESTIGATOR
Hôpital Jean Verdier, Service Hépato-gastroentérologie, Bondy, France
Locations
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CHU, Service Hépato-gastroentérologie
Angers, , France
Hôpital Jean Verdier, Service Hépato-gastroentérologie
Bondy, , France
Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive
Pessac, , France
Department of Clinical Medicine, Policlinico S. Orsola Malpighi
Bologna, , Italy
Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico,
Milan, , Italy
Iuliu Hatieganu University of Medicine and Pharmacy
Cluj-Napoca, , Romania
Royal Free Hospital, Pond Street
London, , United Kingdom
Countries
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References
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Stefanescu H, Marasco G, Cales P, Fraquelli M, Rosselli M, Ganne-Carrie N, de Ledinghen V, Ravaioli F, Colecchia A, Rusu C, Andreone P, Mazzella G, Festi D. A novel spleen-dedicated stiffness measurement by FibroScan(R) improves the screening of high-risk oesophageal varices. Liver Int. 2020 Jan;40(1):175-185. doi: 10.1111/liv.14228. Epub 2019 Sep 11.
Other Identifiers
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M116
Identifier Type: -
Identifier Source: org_study_id
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