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NCT Number: NCT01241227

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

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.

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Key information

Conditions

Liver Fibrosis Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre d'Investigation de la Fibrose hépatique Service Hepato-Gastroentérologie Hopital Haut-Leveque

Pessac, 33200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • ascitis

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 3 months

Secondary outcomes

  1. Survival without liver complications

    Time frame: 3 months

  2. Survival without liver transplantation

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Association HGE CHU Bordeaux Sud

Other

Registry information

Official study 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

Acronym: PVTE

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Nov 16, 2010
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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