Trials / Completed
CompletedNCT01241227
Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease
Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease. A Prospective Follow-up of 4,935 Person-years
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,830 (actual)
- Sponsor
- Association HGE CHU Bordeaux Sud · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this prospective study was to compare the 5-year prognostic value of transient elastography (TE), FibroTest (FT), APRI , FIB-4, Lok, and Child-Pugh scores for predicting survival and complications of cirrhosis in patients with chronic liver diseases.
Detailed description
A total of 1616 patients with chronic hepatitis C was included. At 5 years, 79 patients were dead (39 liver-related deaths) and 16 patients had liver transplantation. Overall survival was 91.7% and survival without liver-related death 94.4%. Survival was significantly decreased in patients diagnosed with severe fibrosis, whatever the non-invasive method used. All these methods were able to predict a shorter survival in this large population. Patients had their prognosis decreased as liver stiffness increased. By multivariate analysis, only FibroTest \> 0.74 (OR 4.41, 95%CI 1.62-12.01, p=0.004) was associated with overall survival, and liver stiffness \> 9.5 kPa (OR 4.71, 95%CI 1.06-21.01, p=0.04) associated with liver-related death.
Conditions
Timeline
- Start date
- 2003-04-01
- Primary completion
- 2009-02-01
- Completion
- 2009-02-01
- First posted
- 2010-11-16
- Last updated
- 2023-07-20
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01241227. Inclusion in this directory is not an endorsement.