Comparison of Two sTRAtegies For the Non-Invasive Diagnosis of advanCed Liver Fibrosis in NAFLD
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- NAFLD
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Single Arm study including patients with NAFLDMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
FIB4-FS and the eLIFT-FMVCTE were previosuly directly compared in a database of biopsy-proven NAFLD patients. These two algorithms showed a very good >80% diagnostic accuracy for advanced fibrosis and a very low <15% rate of liver biopsy requirement. The eLIFT-FMVCTE had a significantly higher diagn...
FIB4-FS and the eLIFT-FMVCTE were previosuly directly compared in a database of biopsy-proven NAFLD patients. These two algorithms showed a very good >80% diagnostic accuracy for advanced fibrosis and a very low <15% rate of liver biopsy requirement. The eLIFT-FMVCTE had a significantly higher diagnostic accuracy (84.6% vs 80.6%, p=0.15), was more specific, and provided higher negative and positive predictive value and higher non-invasive diagnostic accuracy. Finally, these preliminary results suggested the eLIFT-FMVCTE was most suitable for clinical practice than the FIB4-FS. However, because almost all these patients from this preliminary comparative study came from the population where the eLIFT-FMVCTE was developed with thus an optimism bias, the results from this direct comparison require further validation. Therefore, FIB4-FS and the eLIFT-FMVCTE algorithms must now be evaluated and compared in an independent population of NAFLD patients to determine which strategy is the best one for clinical practice.
Tracking Information
- NCT #
- NCT04681573
- Collaborators
- Not Provided
- Investigators
- Not Provided