Trials / Completed
CompletedNCT02876146
Alveolar Echinococcosis: Parasite Viability and Innovative Markers for the Follow-up of Patients Treated With Albendazole
Alveolar Echinococcosis: Parasite Viability and Innovative Markers for Follow-up of Patients Treated With Albendazole - EchinoVISTA Prospective Clinical Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Besancon · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Benzimidazole | Withdrawal of benzimidazole after 4 years (non operable AE) or one year after surgery (curative hepatectomy) |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2021-08-01
- Completion
- 2021-08-01
- First posted
- 2016-08-23
- Last updated
- 2021-08-23
Source: ClinicalTrials.gov record NCT02876146. Inclusion in this directory is not an endorsement.