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

Sponsor

Rennes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01789008

Collaborator

(none)

300

Enrollment

Location

Arms

54.5

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholism Liver Disease Liver Fibrosis	Other: Determination of Advanced Fibrosis in Alcoholic Liver Disease	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Interest of Transient Elastography in the Determination of Advanced Fibrosis in Alcoholic Liver Didease in Alcoholic Patients in Weaning.

Actual Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Jun 19, 2017

Actual Study Completion Date :

Aug 18, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Transient elastography

evaluation of fibrosis stage by transient elastography

Other: Determination of Advanced Fibrosis in Alcoholic Liver Disease

Active Comparator: liver biopsie

evaluation of fibrosis stage by liver biopsie

Other: Determination of Advanced Fibrosis in Alcoholic Liver Disease

Outcome Measures

Primary Outcome Measures

Accuracy of transient elastography will be evaluated by AUC [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.