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

Not Applicable

Completed

• Conditions: Alcoholism; Liver Disease; Liver Fibrosis
• Interventions: Other: Determination of Advanced Fibrosis in Alcoholic Liver Disease

• Registration Number: NCT01789008
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-11
• Primary Completion: 2017-06-19
• Study Completion: 2017-08-18
• Status Verified: 2018-09
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transient elastography	Determination of Advanced Fibrosis in Alcoholic Liver Disease	evaluation of fibrosis stage by transient elastography
liver biopsie	Determination of Advanced Fibrosis in Alcoholic Liver Disease	evaluation of fibrosis stage by liver biopsie

Primary Outcome Measures

Name	Time	Method
Accuracy of transient elastography will be evaluated by AUC	2 months

Trial Locations

Locations (1)

Rennes university hospital; 🇫🇷 Rennes, France