Combining MRI Steatosis Assessment and Transient Elastography to Improve Liver Fibrosis Diagnosis in Non Alcoholic Fatty Liver Disease

Completed

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Procedure: Liver biopsy; Device: Abdominal MRI; Device: Transient elastography

• Registration Number: NCT03245606
• Lead Sponsor: Rennes University Hospital

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 NAFLD.

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 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 :

* Magnetic Resonance Imaging can quantify liver steatosis accurately.

* Transient elastography (Fibroscan®) is approved for the diagnosis of fibrosis in chronic hepatitis C. However results in NAFLD were disappointing. Further, steatosis by heightening liver elasticity is thought to be the cause of these poor results.

* Several biological tests or score are also approved in chronic hepatitis C, but not in NAFLD.

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.

Study Timeline

• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-10
• Study Start: 2017-12-07
• Status Verified: 2020-07
• Primary Completion: 2020-07-07
• Study Completion: 2020-07-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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:

  • 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Non Alcoholic Fatty Liver Disease	Transient elastography	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: * a liver biopsy * an abdominal MRI * a transient elastography
Patients with Non Alcoholic Fatty Liver Disease	Liver biopsy	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: * a liver biopsy * an abdominal MRI * a transient elastography
Patients with Non Alcoholic Fatty Liver Disease	Abdominal MRI	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: * a liver biopsy * an abdominal MRI * a transient elastography

Primary Outcome Measures

Name	Time	Method
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	Day 1	Determination of the fibrosis stage by a double blind reading of liver biopsy by experienced pathologist

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (9)

CHD Vendée; 🇫🇷 La Roche-sur-Yon, France

CHU de Nantes; 🇫🇷 Nantes, France

Centre Hospitalier Bretagne Atlantique; 🇫🇷 Vannes, France

Groupe Hospitalier Bretagne Sud; 🇫🇷 Lorient, France

CHU d'Angers; 🇫🇷 Angers, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU de Rennes; 🇫🇷 Rennes, France

CH de Saint Brieuc; 🇫🇷 Saint-Brieuc, France

CHU de Toulouse; 🇫🇷 Toulouse, France