Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
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.
Verified date | August 2016 |
Source | Echosens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 450 |
Est. completion date | January 17, 2017 |
Est. primary completion date | January 17, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Elizabeth Hospital Birmingham | Birmingham | |
United Kingdom | Addenbrooke's Hospital | Cambridge | |
United Kingdom | Royal Free Hospital | London | |
United Kingdom | Freeman Hospital | Newcastle upon Tyne | |
United Kingdom | Queen's Medical Centre Nottingham | Nottingham | |
United Kingdom | John Radcliffe Hopsital | Oxford | |
United Kingdom | Derriford Hospital | Plymouth |
Lead Sponsor | Collaborator |
---|---|
Echosens |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | Up to 24 month | ||
Primary | 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. | Up to 24 month | ||
Secondary | Clinical, histological and biological factors associated CAP will be assessed using multivariate correlation. | Up to 24 month |
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