Clinical Trials Directory

Trials / Unknown

UnknownNCT06483880

The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection

The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection: a Randomised Controlled Trial

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
24 (estimated)
Sponsor
Ain Shams University · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

The aim of this study is to study the role of adjuvant Albendazole after pulmonary hydatid cyst resection versus placebo in reducing recurrence with a short- term follow-up of six months.

Detailed description

Hydatid disease, also referred to as cystic echinococcosis, is a major zoonotic disease with global distribution caused by the larval stage of the Echinococcus parasite, which belongs to the Taeniidae family and Echinococcus genus. Cystic Echinococcosis is prevalent in several regions across the globe, including Mediterranean countries, southern America, Australia, eastern and northern Africa, as well as the Tibetan terrain of Asia. Dogs and other members of the canid family serve as definitive hosts, as they harbor adult tapeworms within their intestinal tract and excrete parasite eggs in their feces. The intermediate hosts, which encompass a wide range of mammalian species including humans, can get accidentally infected through the ingestion of eggs via food or water that has been contaminated. Upon ingestion of tapeworm eggs found in the feces of dogs, the embryos are liberated from the eggs, traverse the intestinal mucosa, and disseminate to various organs via the bloodstream. The liver accounting for 60% to 70% of infections, and the lungs, comprising around 20% to 30% of infected cases, are the organs most frequently affected by infection. Surgery is the gold standard treatment to get rid of a pulmonary hydatid cyst, though in some rare cases chemotherapy may be necessary. Despite claims that very small cysts can disappear on their own, surgery remains the gold standard for treating hydatid cysts. Re-surgery after recurrence is associated with increased operative morbidity and mortality. Surgical intervention may sometimes be required due to the development of complications in patients who receive only medical treatment. Mebendazole was initially used for the therapeutic treatment of the hydatid cyst. Nevertheless, the drug's uptake from the gastrointestinal tract was poor, prompting its substitution with albendazole, which has better absorption. The drug's activity is enhanced by its metabolite, albendazole sulfoxide, which readily diffuses through the cyst membrane and accumulates in the cyst fluid. It has been shown that adjuvant albendazole treatment is effective in reducing recurrence postoperatively in liver hydatidosis. The standard care in Ain Shams University Hospitals regarding prescription of albendazole after surgery is surgeon's preference. To the best of our knowledge, there was a gap of knowledge regarding the role of adjuvant Albendazole after pulmonary hydatid cyst resection. So, we will conduct this study.

Conditions

Interventions

TypeNameDescription
DRUGAlbendazolePatients will receive albendazole therapy at the recommended dosage.
DRUGPlaceboPatients will receive the placebo, which will be starch tablets in the same dosage of albendazole.

Timeline

Start date
2024-02-01
Primary completion
2025-06-01
Completion
2025-07-01
First posted
2024-07-03
Last updated
2025-02-17

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06483880. Inclusion in this directory is not an endorsement.