Transient Elastography in the Determination of Advanced Fibrosis in Alcoholic Liver Disease.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-08-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcoholism Liver Disease Liver Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Transient elastography

evaluation of fibrosis stage by transient elastography

Group Type OTHER

Determination of Advanced Fibrosis in Alcoholic Liver Disease

Intervention Type OTHER

liver biopsie

evaluation of fibrosis stage by liver biopsie

Group Type ACTIVE_COMPARATOR

Determination of Advanced Fibrosis in Alcoholic Liver Disease

Intervention Type OTHER

Interventions

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Determination of Advanced Fibrosis in Alcoholic Liver Disease

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No