Clinical trial NCT02876146: Alveolar Echinococcosis: Parasite Viability and Innovative Markers for the Follow-up of Patients Treated With Albendazole
Official title: Alveolar Echinococcosis: Parasite Viability and Innovative Markers for Follow-up of Patients Treated With Albendazole - EchinoVISTA Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Echinococcosis
Keywords: Albendazole
Benzimidazole
Echinococcus multilocularis
Alveolar echinococcosis
Liver Diseases
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ratio of non-operated on patients with negative viability markers after a 4 years benzimidazole treatment
timeFrame: 4 years after last inclusion
Secondary outcomes:
measure: Ratio of non-operated on patients without AE relapse after benzimidazole withdrawal
timeFrame: 7 years after last inclusion
measure: Ratio of operated on patients without AE relapse after benzimidazole withdrawal
timeFrame: 3 years after last inclusion
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Besançon
name: Frédéric GRENOUILLET, PharmD, PhD
role: STUDY_CHAIR
affiliation: University Hospital Besançon
name: Carine RICHOU, MD
role: PRINCIPAL_INVESTIGATOR
References: