Spleen Stiffness Measurement With FibroScan

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

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Device: Fibroscan® examination

• Study Type: Interventional
• Enrollment (Actual): 403
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU, Service Hépato-gastroentérologie
  • Bondy, France, 93140
    • Hôpital Jean Verdier, Service Hépato-gastroentérologie
  • Pessac, France, 33604
    • Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive
• Italy
  • Bologna, Italy, 40138
    • Department of Clinical Medicine, Policlinico S. Orsola Malpighi
  • Milano, Italy, 20122
    • Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico,
• Romania
  • Cluj-Napoca, Romania, 400162
    • Iuliu Hatieganu University of Medicine and Pharmacy
• United Kingdom
  • London, United Kingdom, NW3 2QR
    • Royal Free Hospital, Pond Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Selection of patient with cirrhosis using LSM ≥ 14 kPa (kilopascal)	Up to 36 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Diagnosis of large OV with an sensitivity of 95% and an acceptable lower bound of 85%	Up to 36 month

Other Outcome Measures

Outcome Measure	Time Frame
Prevalence of patients with large OV in cirrhotic patients: 30%	Up to 36 month

Collaborators and Investigators

• Sponsor: Echosens
• Investigators: Principal Investigator: Davide FESTI, Pr., Department of Clinical Medicine, Policlinico S. Orsola Malpighi, Bologna, Italy; Principal Investigator: Horia STEFANESCU, Dr., Iuliu Hatieganu University of Medicine and Pharmacy, Clu-Napoca, Romania; Principal Investigator: Victor de LEDINGHEN, Pr., Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive, Pessac, France; Principal Investigator: Paul CALES, Pr., CHU, Service Hépato-gastroentérologie, Angers, France; Principal Investigator: Mirella FRAQUELLI, Dr., Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milano, Italy; Principal Investigator: Nathalie CARRIE-GANNE, Pr., Hôpital Jean Verdier, Service Hépato-gastroentérologie, Bondy, France

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: July 1, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 2, 2014

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Portal Hypertension; Fibroscan; Cirrhotic patients; Liver Stiffness Measurement; Oesophageal Varices; Spleen Stiffness Measurement
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: M116