Status:
COMPLETED
Combining MRI Steatosis Assessment and Transient Elastography to Improve Liver Fibrosis Diagnosis in Non Alcoholic Fatty Liver Disease
Lead Sponsor:
Rennes University Hospital
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18+ years
Brief Summary
The main objective is to compare the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with N...
Detailed Description
No alcoholic fatty liver disease (NAFLD) is induced by an abnormal build up of fat in the liver. It can induce liver damage, namely fibrosis, which leads to cirrhosis and an increased risk of liver ca...
Eligibility Criteria
Inclusion
- Patients older than 18 years old
- For which a liver biopsy is indicated for NAFLD according to current guidelines
- Presenting with at least one of the metabolic syndrome criteria:
- BMI \> 25 kg/m² and/or Waist circumference ≥ à 94cm for men / ≥ à 80cm for women
- Fasting glucose \> or = to 5,6 mmol/L or diabetes / or lowering glucose treatment
- Blood pressure ≥ 130/85 mmHg / or treatment
- Triglycerides ≥ than 1,7 mmol/L
- HDL-C ≤ than 1 mmol/L (men), ≤ 1,3 mmol/L (women) /or lipid lowering treatment
- Affiliated to medical care insurance
- Having signed informed consent for participating in the study
Exclusion
- Associated other chronic liver disease : infectious, auto immune, genetic
- Alcohol consumption higher than 21 standard unit per week for men, or 14 standard unit for women;
- Steatosis inducing treatment: steroids, amiodarone, methotrexate, tamoxifen
- History of bariatric surgery
- Contra indication to MRI (pace maker, metallic foreign body, claustrophobia)
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
Key Trial Info
Start Date :
December 7 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 7 2020
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT03245606
Start Date
December 7 2017
End Date
July 7 2020
Last Update
July 14 2020
Active Locations (9)
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1
CHU d'Angers
Angers, France, 49933
2
CHU de Bordeaux
Bordeaux, France, 33604
3
CHD Vendée
La Roche-sur-Yon, France, 85925
4
Groupe Hospitalier Bretagne Sud
Lorient, France, 56100