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NCT Number: NCT02180113

Spleen Stiffness Measurement With FibroScan

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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Key information

Conditions

Cirrhosis Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Fibrosis Gastrointestinal Diseases Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU, Service Hépato-gastroentérologie, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fibroscan® examination

Device

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).

Primary outcomes

  1. Selection of patient with cirrhosis using LSM ≥ 14 kPa (kilopascal)

    Time frame: Up to 36 month

Secondary outcomes

  1. Diagnosis of large OV with an sensitivity of 95% and an acceptable lower bound of 85%

    Time frame: Up to 36 month

Other outcomes

  1. Prevalence of patients with large OV in cirrhotic patients: 30%

    Time frame: Up to 36 month

Sponsors and collaborators

Lead sponsor

Echosens

Industry

Registry information

Official study title

Feasibility and Performances of Spleen Stiffness Measurement as Surrogate Marker for Oesophageal Varices in Cirrhotic Patients.

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jul 2, 2014
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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