Prospective, Cross-sectional and Multicenter Study, Evaluating the Diagnosis Accuracy of the Controlled Attenuation Parameter(CAP) Measured by FibroScan® (Either With M+ or XL+ Probe) in Patient With Non-Alcoholic Fatty Liver Disease Using Liver Biopsy as Reference.

July 26, 2017 updated by: Echosens

Evaluating the Diagnosis Accuracy of the Controlled Attenuation Parameter(CAP) Measured by FibroScan® (Either With M+ or XL+ Probe) in Patient With Non-Alcoholic Fatty Liver Disease (NAFLD)Using Liver Biopsy as Reference.

The non-alcoholic fatty liver disease (NAFLD) represents the most common cause of liver disease in the western world. It can progress from steatosis to non-alcoholic steatohepatitis (NASH), and then onto cirrhosis where there is a concomitant risk of developing hepatocellular carcinoma (HCC). The prevalence of hepatic steatosis is high, ranging from 16 to 31% in the general population, up to 80% in the obese populationand up to 96% in severely obese patients.

Liver biopsy (LB) has traditionally been regarded as the gold standard for the assessment of patients with NAFLD, although it has several limitations. LB has a potential sampling error, is an invasive and often painful procedure.

The natural history of patients with NAFLD is generally determined by the extent of liver fibrosis, hence non-invasive assessment of fibrosis with FibroScan® is often sufficient. For patients with proven NASH, changes in hepatic steatosis and serum ALT levels may provide information on the patient's course and/or response to treatment.

Several clinical studies have shown the benefit of measuring hepatic stiffness with the FibroScan® machine using the M+ probe. The ability to identify significant fibrosis and cirrhosis has been demonstrated in normal and overweight patients affected with chronic hepatitis B and C, biliary diseases, alcohol related liver disease (ALD) and NAFLD.

Recently, Echosens has also developed a novel ultrasonic controlled attenuation parameter (CAP) designed to quantify hepatic steatosis using a process based on vibration controlled transient elastography (VCTE™). Studies comparing CAP with liver biopsies in multi-aetiology cases and patients with Hepatitis C Virus (HCV) have shown that there is a good correlation between steatosis assessed histologically and using CAP.

The main objective of this prospective study is to evaluate the diagnosis accuracy of the Controlled attenuation Parameter (CAP) measured by FibroScan® (either with M+ or XL+)in patients with NAFLD to assess liver steatosis using biopsy as a reference.

The study involves adults' patients with suspected NAFLD scheduled to have a liver biopsy within 2 weeks of fibroscan examination and followed by the Hepatology service of four centers in United Kingdom.

Approximately 450 patients (of which 350 will be evaluable) will be enrolled in this study: Around 100 patients will be measured with the M+ probe and around 250 with the XL+ probe.

The inclusion period is from 18 to 24 months. Starting date: January 2014. End of recruitment: June 2017. The duration of the study for a patient is from 1 to 7 days, depending to the exams calendar.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2WB
        • Queen Elizabeth Hospital Birmingham
      • Cambridge, United Kingdom, CB20QQ
        • Addenbrooke's Hospital
      • London, United Kingdom, NW3 2QR
        • Royal Free Hospital
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • Queen's Medical Centre Nottingham
      • Oxford, United Kingdom, OX39DU
        • John Radcliffe Hopsital
      • Plymouth, United Kingdom, PL68DH
        • Derriford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must be at least 18 years of age
  • Patients must be able to give written informed consent
  • Patients with suspected NAFLD
  • Patients scheduled to have a liver biopsy within 2 weeks of Fibroscan examination
  • HBsAg negative, Anti-HCV negative, HCV-RNA negative, HBV-DNA negative

Exclusion Criteria:

  • Unable or unwilling to provide written informed consent
  • Patients with ascites
  • Pregnant women
  • Patients with any active implantable medical device (such as pacemaker or defibrillator)
  • Patients who have had a liver transplant
  • Patients with cardiac failure and/or significant valvular disease
  • Patients with hematochromatosis
  • Refusal to undergo a liver biopsy and/or blood test
  • Alcohol consumption above recommended limits (>14 units/week for women and >21 units/week for men)
  • Confirmed diagnosis of active malignancy, or other terminal disease
  • Patient participation in another clinical trial within the preceding 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fibroscan®
Single arm study. See intervention item for détails..
Device: FibroScan® examination.
The study involves adults' patients with suspected Non-Alcoholic Fatty Liver Disease(NAFLD). The FibroScan® is a device equipped with probes (M+ or XL+), each of which consists of an ultrasonic transducer mounted on the axis of a mechanical vibrator. Liver stiffness and CAP measurements are performed on the right lobe of the liver with the patient in a dorsal decubitus and maximal abduction position. The procedure is non-invasive and painless.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Performance of CAP will be assessed using ROC analysis for the detection of steatosis above 5% - 10% - 30% and 60% using liver biopsy as the reference.
Time Frame: Up to 24 month
Up to 24 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical, histological and biological factors associated CAP will be assessed using multivariate correlation.
Time Frame: Up to 24 month
Up to 24 month

Other Outcome Measures

Outcome Measure
Time Frame
Performances of stiffness will be assessed by ROC analysis for the diagnosing above or equal to F2 fibrosis and cirrhosis (F4)using liver biopsy as the reference.
Time Frame: Up to 24 month
Up to 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Echosens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 17, 2017

Study Completion (Actual)

January 17, 2017

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

November 8, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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