Spleen Stiffness Measurement With FibroScan

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180113
• Other study ID #: M116
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: June 2017

Study information

• Verified date: October 2018
• Source: Echosens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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 ßblockers 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.

Related Conditions & MeSH terms

• Cirrhosis

Intervention

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).

Locations

Country	Name	City	State
France	CHU, Service Hépato-gastroentérologie	Angers
France	Hôpital Jean Verdier, Service Hépato-gastroentérologie	Bondy
France	Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive	Pessac
Italy	Department of Clinical Medicine, Policlinico S. Orsola Malpighi	Bologna
Italy	Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico,	Milano
Romania	Iuliu Hatieganu University of Medicine and Pharmacy	Cluj-Napoca
United Kingdom	Royal Free Hospital, Pond Street	London

Sponsors (1)

Lead Sponsor	Collaborator
Echosens

Countries where clinical trial is conducted

France,  Italy,  Romania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of patients with large OV in cirrhotic patients: 30%		Up to 36 month
Primary	Selection of patient with cirrhosis using LSM = 14 kPa (kilopascal)		Up to 36 month
Secondary	Diagnosis of large OV with an sensitivity of 95% and an acceptable lower bound of 85%		Up to 36 month