Comparison of Two sTRAtegies For the Non-Invasive Diagnosis of advanCed Liver Fibrosis in NAFLD

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

NAFLD, closely linked to overweight and insulin resistance, has reached 25% prevalence worldwide. Advanced liver fibrosis(ALF) must be accurately diagnosed in NAFLD because it defines a subgroup of patients with impaired prognosis, and these patients need a specific management to prevent the occurrence of liver-related complication. Relatively few NAFLD patients develop ALF and it is a challenge for physicians to identify them. Liver biopsy is the reference for liver fibrosis evaluation but this invasive procedure cannot be first-line used in NAFLD. Non-invasive diagnosis of liver fibrosis is now available, especially liver stiffness measurement (LSM) with Fibroscan and blood fibrosis tests. However, Fibroscan is a costly device available only in few specialized centres with thus poor accessibility in face of the large NAFLD population. Blood fibrosis tests can be performed by every physician and are distinguished as complex or simple. Because they include specialized biomarkers, complex blood fibrosis tests are accurate for the diagnosis of ALF but they are quite expensive and not reimbursed, with therefore limited use in clinical practice. Simple blood fibrosis tests have the advantage to include cheap and easy-to-obtain biomarkers with simple calculation thanks to free websites or smartphone applications. Simple blood fibrosis tests are globally less accurate than complex blood fibrosis tests or Fibroscan but, used with a high-sensitivity cut-off, they have the high interest of being able to accurately rule out advanced fibrosis in a significant proportion of NAFLD patients. Recently, two sequential diagnostic procedures have been developed for the diagnosis of ALF with the idea to combine the advantages of the different kind of fibrosis tests: the FIB4-Fibroscan (FIB4-FS) and the eLIFT-FibroMeterVCTE (eLIFT-FMVCTE) algorithms. These algorithms include as first-line procedure a simple blood fibrosis test (FIB4 or eLIFT) which identifies the patients who require a further second-line evaluation with a more accurate non-invasive test (Fibroscan or FibroMeterVCTE). Liver biopsy is finally used as third-line procedure in patients for whom the diagnosis remains undetermined. Such algorithms have the advantage to limit the use of complex fibrosis tests only to a subset of at risk-patients. The TRAFIC study compare two strategies for the diagnosis of ALF in NAFLD patients: the FIB4-Fibroscan algorithm and the eLIFT-FibroMeterVCTE algorithm

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Presence of NAFLD as defined by :

‣ The presence of liver steatosis as assessed by ultrasonography (bright liver) or magnetic resonance imaging/spectroscopy (fat fraction \>5.6%) or Controlled Attenuation Parameter (≥248 dB/m)

⁃ The absence of steatosis-inducing drugs (systemic corticosteroids, methotrexate, amiodarone, tamoxifen)

⁃ The absence of excessive alcohol consumption (\<210 g/week in men or \<140 g/week in women)

⁃ The absence of other causes of chronic liver disease (chronic viral hepatitis B or C, hemochromatosis, auto-immune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease alpha-1-antitrypsin deficiency).

• Age ≥18 years and ≤80 years

• Affiliated person or beneficiary of a social security regime

• Written informed consent of the patient who agree to comply with the study protocol.

Locations
Other Locations
France
University Hospital of Angers
RECRUITING
Angers
Avicenne Hospital (Greater Paris University Hospitals)
NOT_YET_RECRUITING
Bobigny
University Hospital of Dijon
RECRUITING
Dijon
Departemental Hospital Center of Vendée
RECRUITING
La Roche-sur-yon
University Hospital of Grenoble
ACTIVE_NOT_RECRUITING
La Tronche
University Hospital of Lille
ACTIVE_NOT_RECRUITING
Lille
University Hospital of Limoges
ACTIVE_NOT_RECRUITING
Limoges
La Croix Rousse Hospital
RECRUITING
Lyon
University Hospital of Montpellier
RECRUITING
Montpellier
University Hospital of Nantes
ACTIVE_NOT_RECRUITING
Nantes
La Pitié Salpétrière Hospital (Greater Paris University Hospitals)
NOT_YET_RECRUITING
Paris
Saint-Antoine Hospital (Greater Paris University Hospitals)
ACTIVE_NOT_RECRUITING
Paris
University Hospital of Bordeaux
ACTIVE_NOT_RECRUITING
Pessac
University Hospital of Rennes
ACTIVE_NOT_RECRUITING
Rennes
University Hospital of Tours
ACTIVE_NOT_RECRUITING
Tours
Contact Information
Primary
Jérôme Boursier, MD-PHD
jeboursier@chu-angers.fr
+33241353410
Backup
Marc de Saint Loup
madesaintloup@chu-angers.fr
+33241357812
Time Frame
Start Date: 2022-04-07
Estimated Completion Date: 2028-12-07
Participants
Target number of participants: 1045
Treatments
Other: Single ARM
Only one arm
Sponsors
Leads: University Hospital, Angers

This content was sourced from clinicaltrials.gov