Alveolar Echinococcosis
Conditions
Keywords
Albendazole, Benzimidazole, Echinococcus multilocularis, Alveolar echinococcosis, Liver Diseases
Brief summary
Study design to define improved management of patients with hepatic alveolar echinococcosis treated with albendazole and especially make appropriate and timely decision of treatment withdrawal . Based on exploratory analysis of existing and newly developed biological and imaging exams, for diagnosis and follow-up, and study of the relationship of these markers to the viability of the parasite and/or the activity of the parasitic lesions The study included two series of patients: operated on (curative hepatectomy) // non-operated on
Detailed description
Close follow-up of the patients, based on WHO guidelines (Brunetti, Acta tropica 2010), including albendazole bloods levels determination. Clinical exam, sampling and storing (biobank) of blood specimens at inclusion, M1, M3, M6, M9, M12, M18, M24, M30, M36, M44, M48. Additional sampling for operated on patients : M15 and M21. Imaging each year (US, CT, PET-CT & RMI). Preservation of operative specimens samples at -80°C: samples taken at different location (center and periphery of the lesions) and in distant non-infected liver, for further studies of the immune response, RNA detection, and albendazole dosages.
Interventions
DRUGBenzimidazole
Withdrawal of benzimidazole after 4 years (non operable AE) or one year after surgery (curative hepatectomy)
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* hepatic alveolar echinococcosis * without antiparasitic treatment or with antiparasitic treatment and hepatectomy programmed
Exclusion criteria
* Patients with exclusively extra-hepatic form of alveolar echinococcosis * Women without effective contraception (Contraindication to benzimidazoles) * The immunosuppressed patients or receiving an immunosuppressive treatment will not be the object of a stop of the post-operative treatment by albendazole on 1 year after the intervention of radical resection; they can be included in the study but will receive the albendazole during 2 years; this exclusion applies to the patients treated by liver transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of non-operated on patients with negative viability markers after a 4 years benzimidazole treatment | 4 years after last inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of non-operated on patients without AE relapse after benzimidazole withdrawal | 7 years after last inclusion | Benzimidazole withdrawal after 4 years, then 3 years of close follow-up |
| Ratio of operated on patients without AE relapse after benzimidazole withdrawal | 3 years after last inclusion | Benzimidazole withdrawal one year after surgery, then 3 years of close follow-up |
Outcome results
None listed