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Spleen Stiffness Measurement With FibroScan

Primary Purpose

Cirrhosis

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Fibroscan® examination

About this trial

This is an interventional diagnostic trial for Cirrhosis focused on measuring Cirrhotic patients, Fibroscan, Liver Stiffness Measurement, Oesophageal Varices, Portal Hypertension, Spleen Stiffness Measurement

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

CHU, Service Hépato-gastroentérologie
Hôpital Jean Verdier, Service Hépato-gastroentérologie
Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive
Department of Clinical Medicine, Policlinico S. Orsola Malpighi
Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico,
Iuliu Hatieganu University of Medicine and Pharmacy
Royal Free Hospital, Pond Street

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Fibroscan®

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02180113

First Posted

July 1, 2014

Last Updated

October 9, 2018

Sponsor

Echosens

1. Study Identification

Unique Protocol Identification Number

NCT02180113

Brief Title

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

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Echosens

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

403 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fibroscan®

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Fibroscan® examination

Intervention Description

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 Outcome Measure Information:

Title

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

Time Frame

Up to 36 month

Secondary Outcome Measure Information:

Title

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

Time Frame

Up to 36 month

Other Pre-specified Outcome Measures:

Title

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

Time Frame

Up to 36 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: