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

August 20, 2021 updated by: Centre Hospitalier Universitaire de Besancon

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Hepatic alveolar echinococcosis

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)
Drug: Benzimidazole
Withdrawal of benzimidazole after 4 years (non operable AE) or one year after surgery (curative hepatectomy)
Other Names:
  • Standardized earlier withdrawal of albendazole

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 years after last inclusion
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
3 years after last inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Study Chair: Frédéric GRENOUILLET, PharmD, PhD, University Hospital Besancon
  • Principal Investigator: Carine RICHOU, MD, University Hospital Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

August 1, 2021

Study Completion (ACTUAL)

August 1, 2021

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (ESTIMATE)

August 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R/2011/41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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