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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 NAFLD.
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 cancer. The diagnosis of liver fibrosis is thus critical to identify patients at risk.
Liver biopsy is the gold standard for the diagnosis of liver fibrosis. However this invasive test is expensive and has a significant morbidity.
To avoid this others non invasive test have been developed to assess steatosis and fibrosis of the liver :
The hypothesis driving this study is that by accounting for liver steatosis through the mean of MRI, we could more accurately interpret transient elastography value to accurately diagnose the severity of liver fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Non Alcoholic Fatty Liver Disease | Patients (240) will undergo a medical examination in order to analyse their medical history and check inclusion and non-inclusion criterions. Then will be performed:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver biopsy | Procedure | Measurement of liver fibrosis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of 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 NAFLD | Determination of the fibrosis stage by a double blind reading of liver biopsy by experienced pathologist | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of accuracy of transient elastography corrected according to the degree of liver steatosis determined by MRI for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD compared to liver biopsy | Day 1 | |
| Assessment of accuracy of transient elastography taking into account liver steatosis determined by MRI, for the diagnosis of liver fibrosis at all fibrosis stage (F1-F2-F3-F4) in patient with NAFLD compared to liver biopsy |
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Inclusion Criteria:
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:
Affiliated to medical care insurance
Having signed informed consent for participating in the study
Exclusion Criteria:
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Patients with NAFLD
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Angers | 49933 | France | |||
| CHU de Bordeaux |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41334457 | Derived | Masrour O, Ehrhard F, Guillaume M, Boursier J, Gournay J, Aziz K, Schnee M, Garlantezec R, de Ledinghen V, Morcet J, Laine F, Allaume P, Turlin B, Gandon Y, Bardou-Jacquet E. Diagnostic accuracy of transient elastography in MASLD is independent of MRI-PDFF steatosis in a multicenter study. JHEP Rep. 2025 Sep 11;7(12):101589. doi: 10.1016/j.jhepr.2025.101589. eCollection 2025 Dec. |
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| Abdominal MRI |
| Device |
Measurement of liver fibrosis |
|
| Transient elastography | Device | Measurement of liver fibrosis |
|
| Day 1 |
| Assessment of accuracy of transient elastography corrected according to the degree of liver steatosis determined by MRI for the diagnosis of liver fibrosis at all fibrosis stage (F1-F2-F3-F4) in patient with NAFLD compared to liver biopsy | Day 1 |
| Assessment of accuracy of Acoustic Radiation Force Impulse for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD compared to liver biopsy | Day 1 |
| Bordeaux |
| 33604 |
| France |
| CHD Vendée | La Roche-sur-Yon | 85925 | France |
| Groupe Hospitalier Bretagne Sud | Lorient | 56100 | France |
| CHU de Nantes | Nantes | 44035 | France |
| CHU de Rennes | Rennes | 35033 | France |
| CH de Saint Brieuc | Saint-Brieuc | 22027 | France |
| CHU de Toulouse | Toulouse | 31059 | France |
| Centre Hospitalier Bretagne Atlantique | Vannes | 56000 | France |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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