Spleen Stiffness Measurement With FibroScan

NCT02180113 | Completed

• 1 other identifier: M116
• Study Type: interventional
• Target: 403
• Locations: 4 countries
• Sites: 7

Brief 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.

Conditions

Cirrhosis

Keywords

Cirrhotic patients; Fibroscan; Liver Stiffness Measurement; Oesophageal Varices; Portal Hypertension; Spleen Stiffness Measurement

Outcome Measures

Primary Outcomes (1)

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

  Up to 36 month

Secondary Outcomes (1)

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

  Up to 36 month

Other Outcomes (1)

• Prevalence of patients with large OV in cirrhotic patients: 30%

  Up to 36 month

Study Arms (1)

Fibroscan®

OTHER

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

Interventions

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).

Fibroscan®

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patient unable or unwilling to provide written informed consent.
• Consuming illness (HIV infection, malignancy).
• Associated comorbidities: NASH, hemochromatosis, primary sclerosing cholangitis, primary biliary cirrhosis.
• 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.

Sponsors & Collaborators

• Echosens: lead

Study Sites (7)

CHU, Service Hépato-gastroentérologie

Angers, 49933, France

Location

Hôpital Jean Verdier, Service Hépato-gastroentérologie

Bondy, 93140, France

Location

Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive

Pessac, 33604, France

Location

Department of Clinical Medicine, Policlinico S. Orsola Malpighi

Bologna, 40138, Italy

Location

Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico,

Milan, 20122, Italy

Location

Iuliu Hatieganu University of Medicine and Pharmacy

Cluj-Napoca, 400162, Romania

Location

Royal Free Hospital, Pond Street

London, NW3 2QR, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31444849 DERIVED

MeSH Terms

Conditions

Fibrosis; Esophageal and Gastric Varices; Hypertension, Portal

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Liver Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 2, 2014
• Study Start: March 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

IT (2); GB (1); FR (3); RO (1)