Clinical trial NCT06483880: The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection
Official title: The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Hydatid Cyst
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence of pulmonary hydatid disease
timeFrame: six months
Secondary outcomes:
measure: Liver function tests (AST and ALT) between both groups.
timeFrame: Six months
measure: Length of hospital stay between both groups.
timeFrame: Six months
measure: In hospital mortality between both groups.
timeFrame: Six months
measure: Financial cost between both groups.
timeFrame: Six months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
state: Al Abbasiya
Study officials:
References:
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citation: Teggi A, Lastilla MG, De Rosa F. Therapy of human hydatid disease with mebendazole and albendazole. Antimicrob Agents Chemother. 1993 Aug;37(8):1679-84. doi: 10.1128/AAC.37.8.1679.