NCT01789008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2017

Completed
Last Updated

May 22, 2023

Status Verified

September 1, 2018

Enrollment Period

4.4 years

First QC Date

February 7, 2013

Last Update Submit

May 19, 2023

Conditions

AlcoholismLiver DiseaseLiver Fibrosis

Keywords

Transient elastographyAlcoholic liver diseaseliver fibrosis

Outcome Measures

Primary Outcomes (1)

  • Accuracy of transient elastography will be evaluated by AUC

    2 months

Study Arms (2)

Transient elastography

OTHER

evaluation of fibrosis stage by transient elastography

Other: Determination of Advanced Fibrosis in Alcoholic Liver Disease

liver biopsie

ACTIVE COMPARATOR

evaluation of fibrosis stage by liver biopsie

Other: Determination of Advanced Fibrosis in Alcoholic Liver Disease

Interventions

Determination of Advanced Fibrosis in Alcoholic Liver DiseaseOTHER
Transient elastographyliver biopsie

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes university hospital

Rennes, 35000, France

Location

Related Publications (3)

  • 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.

    PMID: 37078366BACKGROUND

  • 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.

    PMID: 27239119RESULT

  • 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.

    PMID: 33588101DERIVED

MeSH Terms

Conditions

AlcoholismLiver DiseasesLiver CirrhosisLiver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAlcohol-Induced Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 11, 2013

Study Start

February 1, 2013

Primary Completion

June 19, 2017

Study Completion

August 18, 2017

Last Updated

May 22, 2023

Record last verified: 2018-09

Locations

FR(1)