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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albendazole arm | Active Comparator | 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. |
|
| Placebo arm | Placebo Comparator | Patients will receive the placebo, which will be in two equally split doses per day. This is within two 15-day cycles following surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albendazole | Drug | Patients will receive albendazole therapy at the recommended dosage. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of pulmonary hydatid disease | Recurrence of pulmonary hydatid disease in six months in both groups, assessed by:
| six months |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function tests (AST and ALT) between both groups. | AST and ALT will be measured in U/L before operation and after completing the two 15-day cycles of Albendazole or Placebo in either group. And after six months in both groups. | Six months |
| Length of hospital stay between both groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Recruiting | Cairo | Al Abbasiya | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18819855 | Background | Arif SH, Shams-Ul-Bari, Wani NA, Zargar SA, Wani MA, Tabassum R, Hussain Z, Baba AA, Lone RA. Albendazole as an adjuvant to the standard surgical management of hydatid cyst liver. Int J Surg. 2008 Dec;6(6):448-51. doi: 10.1016/j.ijsu.2008.08.003. Epub 2008 Aug 16. | |
| 34587626 | Background | Aydin Y, Ulas AB, Ince I, Kalin A, Can FK, Gundogdu B, Kasali K, Kerget B, Ogul Y, Eroglu A. Evaluation of albendazole efficiency and complications in patients with pulmonary hydatid cyst. Interact Cardiovasc Thorac Surg. 2022 Jan 18;34(2):245-249. doi: 10.1093/icvts/ivab259. |
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| ID | Term |
|---|---|
| D004445 | Echinococcosis, Pulmonary |
| ID | Term |
|---|---|
| D004443 | Echinococcosis |
| D002590 | Cestode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Patients will receive the placebo, which will be starch tablets in the same dosage of albendazole. |
|
| Six months |
| In hospital mortality between both groups. | Six months |
| Financial cost between both groups. | Six months |
| 29956639 | Background | Dehkordi AB, Sanei B, Yousefi M, Sharafi SM, Safarnezhad F, Jafari R, Darani HY. Albendazole and Treatment of Hydatid Cyst: Review of the Literature. Infect Disord Drug Targets. 2019;19(2):101-104. doi: 10.2174/1871526518666180629134511. |
| 28319358 | Background | Fattahi Masoom SH, Lari SM, Fattahi AS, Ahmadnia N, Rajabi M, NaderiKalat M. Albendazole therapy in human lung and liver hydatid cysts: A 13-year experience. Clin Respir J. 2018 Mar;12(3):1076-1083. doi: 10.1111/crj.12630. Epub 2017 Apr 20. |
| 31681642 | Background | Rawat S, Kumar R, Raja J, Singh RS, Thingnam SKS. Pulmonary hydatid cyst: Review of literature. J Family Med Prim Care. 2019 Sep 30;8(9):2774-2778. doi: 10.4103/jfmpc.jfmpc_624_19. eCollection 2019 Sep. |
| 27051107 | Background | Sarkar M, Pathania R, Jhobta A, Thakur BR, Chopra R. Cystic pulmonary hydatidosis. Lung India. 2016 Mar-Apr;33(2):179-91. doi: 10.4103/0970-2113.177449. |
| 8215283 | Background | 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. |
| D007239 |
| Infections |
| D008174 | Lung Diseases, Parasitic |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |