Clinical trial NCT02180113: Spleen Stiffness Measurement With FibroScan
Official title: Feasibility and Performances of Spleen Stiffness Measurement as Surrogate Marker for Oesophageal Varices in Cirrhotic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Keywords: Cirrhotic patients
Fibroscan
Liver Stiffness Measurement
Oesophageal Varices
Portal Hypertension
Spleen Stiffness Measurement
Lead sponsor: Echosens
Sponsor class: INDUSTRY
First posted: 2014-07-02
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Selection of patient with cirrhosis using LSM ≥ 14 kPa (kilopascal)
timeFrame: Up to 36 month
Secondary outcomes:
measure: Diagnosis of large OV with an sensitivity of 95% and an acceptable lower bound of 85%
timeFrame: Up to 36 month
Other outcomes:
measure: Prevalence of patients with large OV in cirrhotic patients: 30%
timeFrame: Up to 36 month
Locations:
city: Angers
country: France
facility: CHU, Service Hépato-gastroentérologie
city: Bondy
country: France
facility: Hôpital Jean Verdier, Service Hépato-gastroentérologie
city: Pessac
country: France
facility: Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive
city: Bologna
country: Italy
facility: Department of Clinical Medicine, Policlinico S. Orsola Malpighi
city: Milano
country: Italy
facility: Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico,
city: Cluj-Napoca
country: Romania
facility: Iuliu Hatieganu University of Medicine and Pharmacy
city: London
country: United Kingdom
facility: Royal Free Hospital, Pond Street
Study officials:
affiliation: Department of Clinical Medicine, Policlinico S. Orsola Malpighi, Bologna, Italy
name: Davide FESTI, Pr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Iuliu Hatieganu University of Medicine and Pharmacy, Clu-Napoca, Romania
name: Horia STEFANESCU, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive, Pessac, France
name: Victor de LEDINGHEN, Pr.
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU, Service Hépato-gastroentérologie, Angers, France
name: Paul CALES, Pr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milano, Italy
name: Mirella FRAQUELLI, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Jean Verdier, Service Hépato-gastroentérologie, Bondy, France
name: Nathalie CARRIE-GANNE, Pr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.