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

Alcoholism Clinical Trial

— FIBR-OH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789008
• Other study ID #: PHRC/12-01
• Secondary ID: 2012-A01171-42
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: August 18, 2017

Study information

• Verified date: September 2018
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 18, 2017
• Est. primary completion date: June 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholism
• Fibrosis
• Liver Cirrhosis
• Liver Disease
• Liver Diseases
• Liver Fibrosis

Intervention

Other:
• Determination of Advanced Fibrosis in Alcoholic Liver Disease

Locations

Country	Name	City	State
France	Rennes university hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (2)

Chalin A, Turlin B, Ousmen A, Michalak S, Mueller J, Mueller S, Legros L, Bardou-Jacquet E, Viel JF, Samson M, Moirand R. Non-invasive diagnosis of alcohol-related steatohepatitis in patients ongoing alcohol withdrawal based on cytokeratin 18 and transient elastography. Aliment Pharmacol Ther. 2023 Apr 20. doi: 10.1111/apt.17515. Online ahead of print. — View Citation

Kiani A, Brun V, Laine F, Turlin B, Morcet J, Michalak S, Le Gruyer A, Legros L, Bardou-Jacquet E, Gandon Y, Moirand R. Acoustic radiation force impulse imaging for assessing liver fibrosis in alcoholic liver disease. World J Gastroenterol. 2016 May 28;22 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of transient elastography will be evaluated by AUC		2 months