Alveolar Echinococcosis: Parasite Viability and Innovative Markers for the Follow-up of Patients Treated With Albendazole
- Registration Number
- NCT02876146
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- hepatic alveolar echinococcosis
- without antiparasitic treatment or with antiparasitic treatment and hepatectomy programmed
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hepatic alveolar echinococcosis Benzimidazole 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)
- Primary Outcome Measures
Name Time Method Ratio of non-operated on patients with negative viability markers after a 4 years benzimidazole treatment 4 years after last inclusion
- Secondary Outcome Measures
Name Time Method 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
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