Clinical trial NCT01789008: Transient Elastography in the Determination of Advanced Fibrosis in Alcoholic Liver Disease.
Official title: Interest of Transient Elastography in the Determination of Advanced Fibrosis in Alcoholic Liver Didease in Alcoholic Patients in Weaning.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Liver Disease
Liver Fibrosis
Keywords: Transient elastography
Alcoholic liver disease
liver fibrosis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of transient elastography will be evaluated by AUC
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes university hospital
Study officials:
References:
citation: 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 Jul;58(1):80-88. doi: 10.1111/apt.17515. Epub 2023 Apr 20.
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(20):4926-35. doi: 10.3748/wjg.v22.i20.4926.
citation: Legros L, Bardou-Jacquet E, Turlin B, Michalak S, Hamonic S, Le Gruyer A, Aziz K, Lemoine C, Bouvard N, Chavagnat JJ, Silvain C, Kerjean J, Le Dreau G, Lacave-Oberti N, Oberti F, Le Lan C, Guyader D, Moirand R. Transient Elastography Accurately Screens for Compensated Advanced Chronic Liver Disease in Patients With Ongoing or Recent Alcohol Withdrawal. Clin Gastroenterol Hepatol. 2022 Jul;20(7):1542-1552.e6. doi: 10.1016/j.cgh.2021.02.021. Epub 2021 Feb 12.