Spleen Stiffness Measurement With FibroScan

Echosens North America

Status: Completed

Conditions: Cirrhosis

Treatments: Device: Fibroscan® examination

Study type: Interventional

Funder types: Industry

Identifiers

NCT02180113

M116

Details and patient eligibility

About

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.

Enrollment: 403 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All groups

  • 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

• Patient unable or unwilling to provide written informed consent.
• 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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403 participants in 1 patient group

Fibroscan®

Other group

Description:

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.

Treatment:

Device: Fibroscan® examination