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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
  Purpose

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.


Condition
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:

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

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

Primary Outcome Measures:
  • Overall survival [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1830
Study Start Date: April 2003
Study Completion Date: February 2009
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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

No publications provided by Association HGE CHU Bordeaux Sud

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Julien Vergniol, CHU de Bordeaux
ClinicalTrials.gov Identifier: NCT01241227     History of Changes
Other Study ID Numbers: HLV-0403
Study First Received: October 22, 2010
Last Updated: November 15, 2010
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Fibrosis
Liver Diseases
Liver Cirrhosis
Pathologic Processes
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013