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Trial Title:
The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection
NCT ID:
NCT06483880
Condition:
Pulmonary Hydatid Cyst
Conditions: Official terms:
Echinococcosis
Echinococcosis, Pulmonary
Cysts
Parovarian Cyst
Albendazole
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Albendazole
Description:
Patients will receive albendazole therapy at the recommended dosage.
Arm group label:
Albendazole arm
Intervention type:
Drug
Intervention name:
Placebo
Description:
Patients will receive the placebo, which will be starch tablets in the same dosage of
albendazole.
Arm group label:
Placebo arm
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.
Criteria for 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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Ain Shams University Hospitals
Address:
City:
Cairo
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Mohaymen Seddik
Phone:
01278317165
Email:
mohaymen96@gmail.com
Start date:
February 1, 2024
Completion date:
August 31, 2024
Lead sponsor:
Agency:
Ain Shams University
Agency class:
Other
Source:
Ain Shams University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06483880
