The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection

Ain Shams University

Status: Enrolling

Conditions: Pulmonary Hydatid Cyst

Treatments: Drug: Albendazole; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06483880

FMASU MS187/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. All patients regardless of age with pulmonary hydatid disease requiring surgical resection.
2. Patients achieving complete resection of pulmonary hydatid disease.
3. Patients with no extra pulmonary hydatid disease.
4. Patients who have received preoperative albendazole.

Exclusion criteria

1. Patients with extra pulmonary hydatid disease requiring treatment after pulmonary resection.
2. Patients with incomplete resection of pulmonary hydatid disease.
3. Patients with pulmonary hydatid disease not amenable for resection.
4. Patients with hypersensitivity to Albendazole.
5. Patients with liver dysfunction.
6. Patients refusing to be enrolled in the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups, including a placebo group

Albendazole arm

Active Comparator group

Description:

The administration of albendazole therapy is recommended at a dosage of 15 mg/kg/day, given in two equally split doses per day. This is within two 15-day cycles following surgery.

Treatment:

Drug: Albendazole

Placebo arm

Placebo Comparator group

Description:

Patients will receive the placebo, which will be in two equally split doses per day. This is within two 15-day cycles following surgery.

Treatment:

Drug: Placebo