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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatic alveolar echinococcosis | Other | Follow-up of standardized clinical, biological, and imaging characteristics (according to the WHO-expert consensus). Albendazole treatment, 400 mg x 2/d (or mebendazole if adverse effects) Standardized earlier withdrawal of benzimidazole :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benzimidazole | Drug | Withdrawal of benzimidazole after 4 years (non operable AE) or one year after surgery (curative hepatectomy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of non-operated on patients with negative viability markers after a 4 years benzimidazole treatment | 4 years after last inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of non-operated on patients without AE relapse after benzimidazole withdrawal | Benzimidazole withdrawal after 4 years, then 3 years of close follow-up | 7 years after last inclusion |
| Ratio of operated on patients without AE relapse after benzimidazole withdrawal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric GRENOUILLET, PharmD, PhD | University Hospital Besançon | Study Chair |
| Carine RICHOU, MD | University Hospital Besançon | Principal Investigator |
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| ID | Term |
|---|---|
| C536591 | Alveolar echinococcosis |
| D004443 | Echinococcosis |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D002590 | Cestode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C031000 | benzimidazole |
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Benzimidazole withdrawal one year after surgery, then 3 years of close follow-up |
| 3 years after last inclusion |
| D004066 |
| Digestive System Diseases |