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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Centre Hospitalier Universitaire de Besancon

Current Primary Outcome: Ratio of non-operated on patients with negative viability markers after a 4 years benzimidazole treatment [ Time Frame: 4 years after last inclusion ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Ratio of non-operated on patients without AE relapse after benzimidazole withdrawal [ Time Frame: 7 years after last inclusion ]
  Benzimidazole withdrawal after 4 years, then 3 years of close follow-up
• Ratio of operated on patients without AE relapse after benzimidazole withdrawal [ Time Frame: 3 years after last inclusion ]
  Benzimidazole withdrawal one year after surgery, then 3 years of close follow-up

Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Besancon

Dates:
Date Received: August 16, 2016
Date Started: June 2012
Date Completion: June 2023
Last Updated: August 22, 2016
Last Verified: July 2016