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Transient Elastography in the Determination of Advanced Fibrosis in Alcoholic Liver Disease. (FIBR-OH)

R

Rennes University Hospital

Status

Completed

Conditions

Alcoholism
Liver Fibrosis
Liver Disease

Treatments

Other: Determination of Advanced Fibrosis in Alcoholic Liver Disease

Study type

Interventional

Funder types

Other

Identifiers

NCT01789008
2012-A01171-42
PHRC/12-01

Details and patient eligibility

About

Alcoholic liver disease is the most frequent complication of excessive alcohol consumption. Early diagnosis of alcoholic liver disease is essential to avoid its complications that could be fatal. To date, the reference diagnostic tool is an invasive procedure: the liver biopsy. The transient elastography is a useful tool for early diagnosis of liver fibrosis. This tool is validated in the diagnosis of liver fibrosis due to C chronic hepatitis. Because it is non-invasive, fast, given immediate results; transient elastography could be repeated in alcoholic patients for liver fibrosis follow-up. In the present study, the investigators propose to realize liver biopsy and transient elastography in 300 alcoholic patients in weaning to evaluate the transient elastography accuracy in the exclusion of sever liver fibrosis (Metavir 3 and 4). The reference liver fibrosis diagnosis tool will be the liver biopsy.

Enrollment

300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients more than 18 years old; hospitalised for alcoholic weaning; with an alcoholic liver disease; with at risk alcoholic consumption; with an indication of liver biopsy; with a signed consentment.

Exclusion criteria

  • patients with a cirrhosis; with other causes of liver disease; with a contraindication of liver biopsy; having had a liver biopsy in the last 3 years; pregnancy; major benefiting from a legal protective measure; no coverage care.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 2 patient groups

Transient elastography
Other group
Description:
evaluation of fibrosis stage by transient elastography
Treatment:
Other: Determination of Advanced Fibrosis in Alcoholic Liver Disease
liver biopsie
Active Comparator group
Description:
evaluation of fibrosis stage by liver biopsie
Treatment:
Other: Determination of Advanced Fibrosis in Alcoholic Liver Disease

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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