Back to resultsTransient Elastography in the Determination of Advanced Fibrosis in Alcoholic Liver Disease. (FIBR-OH)
Primary Purpose
Alcoholism, Liver Disease, Liver Fibrosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Determination of Advanced Fibrosis in Alcoholic Liver Disease
Sponsored by
About this trial
This is an interventional diagnostic trial for Alcoholism focused on measuring Transient elastography, Alcoholic liver disease, liver fibrosis
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.
Sites / Locations
- Rennes university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Transient elastography
liver biopsie
Arm Description
evaluation of fibrosis stage by transient elastography
evaluation of fibrosis stage by liver biopsie
Outcomes
Primary Outcome Measures
Accuracy of transient elastography will be evaluated by AUC
Secondary Outcome Measures
Full Information
NCT ID
NCT01789008
First Posted
February 7, 2013
Last Updated
May 19, 2023
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01789008
Brief Title
Transient Elastography in the Determination of Advanced Fibrosis in Alcoholic Liver Disease.
Acronym
FIBR-OH
Official Title
Interest of Transient Elastography in the Determination of Advanced Fibrosis in Alcoholic Liver Didease in Alcoholic Patients in Weaning.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
June 19, 2017 (Actual)
Study Completion Date
August 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Liver Disease, Liver Fibrosis
Keywords
Transient elastography, Alcoholic liver disease, liver fibrosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transient elastography
Arm Type
Other
Arm Description
evaluation of fibrosis stage by transient elastography
Arm Title
liver biopsie
Arm Type
Active Comparator
Arm Description
evaluation of fibrosis stage by liver biopsie
Intervention Type
Other
Intervention Name(s)
Determination of Advanced Fibrosis in Alcoholic Liver Disease
Primary Outcome Measure Information:
Title
Accuracy of transient elastography will be evaluated by AUC
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Rennes university hospital
City
Rennes
ZIP/Postal Code
35000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
37078366
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.
Results Reference
background
PubMed Identifier
27239119
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.
Results Reference
result
PubMed Identifier
33588101
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.
Results Reference
derived
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Transient Elastography in the Determination of Advanced Fibrosis in Alcoholic Liver Disease.
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