Fibrosis, Liver
Conditions
Keywords
Chlordecone, fibrosis, cirrhosis, chronic hepatitis B, C, alcohol, viral hepatitis, transaminases, fibroscan
Brief summary
Chlordecone is known to induce liver damage in rat and mice but no data exists in human being. However chlordecone was used until 1993 in French West Indies for banana fields, it is important to test what damage can be induced now, for patients exposed. We should consider chlordecone as a potential cofactor of liver fibrosis. So we have chosen to compare two populations of chronic hepatitis B, C or alcoholic, with cirrhosis or without fibrosis due to active hepatitis, who had been exposed to chlordecone.
Detailed description
Actually, there is no data concerning the impact of chlordecone on the evolution of fibrosis to cirrhosis in chronic hepatitis whereas many studies have been reported liver damage in mice. The goal of this study is to know if co-exposition to chlordecone can induce evolution to cirrhosis in chronic hepatitis due to alcohol or viral hepatitis. At first, we will assess a group of patients with chronic hepatitis B, C or due to alcohol without fibrosis. And they will be compared to patients with cirrhosis exposed to chlordecone too. Patients will be included in 2 hospital centers. All these patients should have an active liver disease. The activity will be defined by histology or elevated transaminases (\>2N), fibrosis will be defined by histology or an association of fibroscan and biological markers. Exposition to chlordecone will be evaluated by a blood chlordecone measure for every patient.
Interventions
DIAGNOSTIC_TESTBlood samples
Collected data will contain epidemiological and biological data, blood samples with chlordecone dosage.
Sponsors
Centre Hospitalier Universitaire de la Guadeloupe
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
It is a case-control study. There will be two groups. The patient will be assigned to a group according to the Metavir classification. F0 patients will be in the control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age above 18 years * Active chronic hepatitis B or C or alcoholic * Patient without previous antiviral therapy, activity confirmed by histology or elevated transaminases * Alcohol consumption more than 20g/d for women and 30g/d for men responsible of chronic alcoholic disease * Seronegative HIV status, inform consent signed, health insurance
Exclusion criteria
* Inactive chronic hepatitis * Other chronic hepatitis as auto-immune hepatitis, hemochromatosis, wilson disease, acute hepatitis due to medication, transplantation, antiviral or imunosupressive treatment, psychiatric disease * Co-infection with HIV, HBV or HCV * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of progression to cirrhosis with a correlation test between chlordecone exposure and fibrosis in active and chronic hepatitis due to virus B, C or alcohol. | through study completion, an average of 5 years. | : Chlordecone level will be compared among the two groups (patients with or without significant fibrosis) in order to determine the impact of chlordecone on the evolution of fibrosis. Patients of each group will be paired according to the age, sex, origin of the liver disease. Analysis will be performed using SPSS software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epidemiological study of hepatitis B, C and alcoholic in Guadeloupe | through study completion, an average of 5 years. | Distribution of the main etiologies of chronic hepatitis according to age, sex and origin and severity of the liver disease for patients of each group will be performed. |
Countries
Guadeloupe
Outcome results
None listed