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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.
Information provided by:
Association HGE CHU Bordeaux Sud Identifier:
First received: October 22, 2010
Last updated: November 15, 2010
Last verified: November 2010
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.

Liver Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Association HGE CHU Bordeaux Sud:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Survival without liver complications [ Time Frame: 3 months ]
  • Survival without liver transplantation [ Time Frame: 3 months ]

Enrollment: 1830
Study Start Date: April 2003
Study Completion Date: February 2009
Chronic liver disease
All patients with chronic liver disease followed using FibroScan and non-invasive markers

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

Inclusion Criteria:

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

Exclusion Criteria:

  • ascitis
  Contacts and Locations
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Please refer to this study by its identifier: NCT01241227

Centre d'Investigation de la Fibrose hépatique Service Hepato-Gastroentérologie Hopital Haut-Leveque
Pessac, France, 33200
Sponsors and Collaborators
Association HGE CHU Bordeaux Sud
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Julien Vergniol, CHU de Bordeaux Identifier: NCT01241227     History of Changes
Other Study ID Numbers: HLV-0403
Study First Received: October 22, 2010
Last Updated: November 15, 2010

Keywords provided by Association HGE CHU Bordeaux Sud:
liver fibrosis
transient elastography

Additional relevant MeSH terms:
Liver Diseases
Liver Cirrhosis
Pathologic Processes
Digestive System Diseases processed this record on May 24, 2017