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

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

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Key information

Conditions

Alveolar Echinococcosis Cestode Infections Digestive System Diseases Echinococcosis Helminthiasis Infections Liver Diseases Parasitic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Benzimidazole

Drug

Withdrawal of benzimidazole after 4 years (non operable AE) or one year after surgery (curative hepatectomy)

Other names: Standardized earlier withdrawal of albendazole

Primary outcomes

Ratio of non-operated on patients with negative viability markers after a 4 years benzimidazole treatment

Time frame: 4 years after last inclusion

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: EchinoVISTA

Important dates

Study start: 2012
Primary completion: 2021
Study completion: 2021
First posted: Aug 23, 2016
Registry last updated: Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed