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Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease (PVTE)

This study has been completed.
Sponsor:
Information provided by:
Association HGE CHU Bordeaux Sud
ClinicalTrials.gov Identifier:
NCT01241227
First received: October 22, 2010
Last updated: November 15, 2010
Last verified: November 2010
History of Changes

October 22, 2010
November 15, 2010
April 2003
Not Provided
Overall survival [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01241227 on ClinicalTrials.gov Archive Site
  • Survival without liver complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Survival without liver transplantation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

We included all consecutive patients with an age over eighteen and a chronic hepatitis C of any severity. The determination of chronic hepatitis C was made using standard diagnostic criteria: serological detection of hepatitis C antibodies and positive serum HCV-RNA by PCR for more than 6 months. Exclusion criteria were chronic hepatitis B virus infection and all other causes of chronic liver disease. Patients with HIV infection were included.
Liver Fibrosis
Not Provided
Chronic liver disease
All patients with chronic liver disease followed using FibroScan and non-invasive markers
Vergniol J, Foucher J, Terrebonne E, Bernard PH, le Bail B, Merrouche W, Couzigou P, de Ledinghen V. Noninvasive tests for fibrosis and liver stiffness predict 5-year outcomes of patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1970-9, 1979.e1-3. Epub 2011 Mar 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1830
February 2009
Not Provided

Inclusion Criteria:

  • chronic hepatitis C
  • chronic hepatitis B
  • alcoholic liver disease
  • non alcoholic steatohepatitis

Exclusion Criteria:

  • ascitis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01241227
HLV-0403
Yes
Dr Julien Vergniol, CHU de Bordeaux
Association HGE CHU Bordeaux Sud
Not Provided
Principal Investigator: Julien Vergniol, MD Association HGE CHU Bordeaux Sud
Study Chair: Juliette Foucher, MD Association HGE CHU Bordeaux Sud
Study Chair: Eric Terrebonne, MD Association HGE CHU Bordeaux Sud
Study Chair: Wassil Merrouche Association HGE CHU Bordeaux Sud
Study Director: Victor De Ledinghen, MD, PhD Association HGE CHU Bordeaux Sud
Study Chair: Pierre-Henri Bernard, MD Association HGE CHU Bordeaux Sud
Study Chair: Couzigou Patrice, MD, PhD Association HGE CHU Bordeaux Sud
Association HGE CHU Bordeaux Sud
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP