Clinical trial NCT01241227: Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Fibrosis
Keywords: liver fibrosis
survival
transient elastography
Lead sponsor: Association HGE CHU Bordeaux Sud
Sponsor class: OTHER
First posted: 2010-11-16
Enrollment: 1830
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* ascitis

Primary outcomes:
measure: Overall survival
timeFrame: 3 months
Secondary outcomes:
measure: Survival without liver complications
timeFrame: 3 months
measure: Survival without liver transplantation
timeFrame: 3 months
Other outcomes:
Locations:
city: Pessac
country: France
facility: Centre d'Investigation de la Fibrose hépatique Service Hepato-Gastroentérologie Hopital Haut-Leveque
Study officials:
affiliation: Association HGE CHU Bordeaux Sud
name: Julien Vergniol, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Association HGE CHU Bordeaux Sud
name: Juliette Foucher, MD
role: STUDY_CHAIR
affiliation: Association HGE CHU Bordeaux Sud
name: Eric Terrebonne, MD
role: STUDY_CHAIR
affiliation: Association HGE CHU Bordeaux Sud
name: Wassil Merrouche
role: STUDY_CHAIR
affiliation: Association HGE CHU Bordeaux Sud
name: Victor De Ledinghen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Association HGE CHU Bordeaux Sud
name: Pierre-Henri Bernard, MD
role: STUDY_CHAIR
affiliation: Association HGE CHU Bordeaux Sud
name: Couzigou Patrice, MD, PhD
role: STUDY_CHAIR
References:
citation: Vergniol J, Boursier J, Coutzac C, Bertrais S, Foucher J, Angel C, Chermak F, Hubert IF, Merrouche W, Oberti F, de Ledinghen V, Cales P. Evolution of noninvasive tests of liver fibrosis is associated with prognosis in patients with chronic hepatitis C. Hepatology. 2014 Jul;60(1):65-76. doi: 10.1002/hep.27069.
citation: 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. doi: 10.1053/j.gastro.2011.02.058. Epub 2011 Mar 2.