Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483880
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-23
Brief Title:
The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection a Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 drugs uptake from the gastrointestinal tract was poor prompting its substitution with albendazole which has better absorption The drugs 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 surgeons 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
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 drugs uptake from the gastrointestinal tract was poor prompting its substitution with albendazole which has better absorption The drugs 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 surgeons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None