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

NCT02876146 | Completed

• 1 other identifier: R/2011/41
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Alveolar Echinococcosis

Keywords

Albendazole; Benzimidazole; Echinococcus multilocularis; Alveolar echinococcosis; Liver Diseases

Outcome Measures

Primary Outcomes (1)

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

  4 years after last inclusion

Secondary Outcomes (2)

• Ratio of non-operated on patients without AE relapse after benzimidazole withdrawal

  7 years after last inclusion

• Ratio of operated on patients without AE relapse after benzimidazole withdrawal

  3 years after last inclusion

Study Arms (1)

Hepatic alveolar echinococcosis

OTHER

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

Interventions

Benzimidazole DRUG

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

Also known as: Standardized earlier withdrawal of albendazole

Hepatic alveolar echinococcosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hepatic alveolar echinococcosis
• without antiparasitic treatment or with antiparasitic treatment and hepatectomy programmed

You may not qualify if:

• Patients with exclusively extra-hepatic form of alveolar echinococcosis
• Women without effective contraception (Contraindication to benzimidazoles)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Conditions

Alveolar echinococcosis; Echinococcosis; Liver Diseases

Interventions

benzimidazole

Condition Hierarchy (Ancestors)

Cestode Infections; Helminthiasis; Parasitic Diseases; Infections; Digestive System Diseases

Study Officials

• Frédéric GRENOUILLET, PharmD, PhD

  University Hospital Besançon

  STUDY CHAIR

• Carine RICHOU, MD

  University Hospital Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 23, 2016
• Study Start: June 1, 2012
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 23, 2021

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share