Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399932
Status:
UNKNOWN
Last Update Posted:
2009-09-18
First Post:
2006-11-14
Brief Title:
Non-invasive Evaluation of Hepatic Fibrosis in Patients With the Metabolic Syndrome
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2009-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Non-alcoholic fatty liver disease NAFLD is now recognised as the hepatic complication of the metabolic syndrome of insulin resistance In some patients the disease can progress into steatohepatitis NASH which associates fatty liver hepatocellular damage chronic inflammation and variable and progressive fibrosis The latter can evolve into cirrhosis and end-stage liver disease
Thus the presence of fibrosis sign the severity of the disease and therefore its accurate detection is crucial for the identification of patients in need of treatment and appropriate follow-up
To date histological examination of a biopsy of the liver is the gold standard in the diagnosis of fibrosis the procedure is however associated with significant complication in 001 to 01 of cases and with sampling errors because it analyses only a minimal portion fo the liver
The aim of the study is to evaluate in a population of patients with the metabolic syndrome whether non-invasive tests may identify those with hepatic fibrosis
At inclusion serum tests fibroscan elastography of the liver by ultra-sounds and elastography by MRI will be performed Those tests will be repeated within 2 months
A liver biopsy will be performed if 2 out of the 3 serum test fibroscan or elastography tests are suggestive of hepatic fibrosis
This study will allow to determine
whether hepatic fibrosis may be detected by non-invasive means in patients with NAFLDNASH
whether there is a correlation between non-invase tests and liver biopsy for assessment of fibrosis and it severity
whether the presence of fatty liver interfere with the results of the fibroscan and the elastography
whether there are metabolic factors associated with an increased risk of fibrosis in this population
Thus the presence of fibrosis sign the severity of the disease and therefore its accurate detection is crucial for the identification of patients in need of treatment and appropriate follow-up
To date histological examination of a biopsy of the liver is the gold standard in the diagnosis of fibrosis the procedure is however associated with significant complication in 001 to 01 of cases and with sampling errors because it analyses only a minimal portion fo the liver
The aim of the study is to evaluate in a population of patients with the metabolic syndrome whether non-invasive tests may identify those with hepatic fibrosis
At inclusion serum tests fibroscan elastography of the liver by ultra-sounds and elastography by MRI will be performed Those tests will be repeated within 2 months
A liver biopsy will be performed if 2 out of the 3 serum test fibroscan or elastography tests are suggestive of hepatic fibrosis
This study will allow to determine
whether hepatic fibrosis may be detected by non-invasive means in patients with NAFLDNASH
whether there is a correlation between non-invase tests and liver biopsy for assessment of fibrosis and it severity
whether the presence of fatty liver interfere with the results of the fibroscan and the elastography
whether there are metabolic factors associated with an increased risk of fibrosis in this population
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None