Alveolar Echinococcosis: Parasite Viability and Innovative Markers for the Follow-up of Patients Treated With Albendazole

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Alveolar Echinococcosis: Parasite Viability and Innovative Markers for Follow-up of Patients Treated With Albendazole - EchinoVISTA Prospective Clinical Study

Conditions
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Alveolar Echinococcosis

Intervention / Treatment
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* Drug: Benzimidazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hepatic alveolar echinococcosis<br>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 : Patients with non operable hepatic AE lesion : Withdrawal of benzimidazole treatment for patients without metastasis or neighbouring lesions (PxN0M0) after at least 4 years when viability markers became negative (PET-CT, serological markers) Curative hepatectomy : Earlier withdrawal of benzimidazole treatment for patients without metastasis or neighbouring lesions (PxN0M0) after one year (WHO guidelines : 2 years), if viability markers became negative. Close prospective follow-up after withdrawal (PET-CT, serological markers) | Drug: Benzimidazole<br>* Withdrawal of benzimidazole after 4 years (non operable AE) or one year after surgery (curative hepatectomy)<br>* Other names: Standardized earlier withdrawal of albendazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Benzimidazole withdrawal one year after surgery, then 3 years of close follow-up | 3 years after last inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Albendazole, Benzimidazole, Echinococcus multilocularis, Alveolar echinococcosis, Liver Diseases