Pulmonary Hydatid CystNCT06483880
The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection
A study testing Albendazole in people with Pulmonary Hydatid Cyst, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hydatid Cyst
- What is being tested?
- Albendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients regardless of age with pulmonary hydatid disease requiring surgical resection.
- Patients achieving complete resection of pulmonary hydatid disease.
- Patients with no extra pulmonary hydatid disease.
- Patients who have received preoperative albendazole.
Who cannot join
- Patients with extra pulmonary hydatid disease requiring treatment after pulmonary resection.
- Patients with incomplete resection of pulmonary hydatid disease.
- Patients with pulmonary hydatid disease not amenable for resection.
- Patients with hypersensitivity to Albendazole.
- Patients with liver dysfunction.
- Patients refusing to be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospitals
Cairo, Al Abbasiya
Mohaymen Seddik, 01278317165, mohaymen96@gmail.com
About this study
Official title: The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection: a Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Pulmonary Hydatid Cyst
- Being tested
- Albendazole, Placebo
- Medical subject headings
- Echinococcosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
Patients will receive albendazole therapy at the recommended dosage.
PlaceboDrug
Patients will receive the placebo, which will be starch tablets in the same dosage of albendazole.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Albendazole |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of pulmonary hydatid disease
Recurrence of pulmonary hydatid disease in six months in both groups, assessed by:
- Chest X-ray radiography after the 2 weeks.
- CT chest in six months and after one year or symptoms requiring CT chest at any timing.
Measured: six months
Secondary outcomes (4)
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.
Measured: Six months
Length of hospital stay between both groups.
Measured: Six months
In hospital mortality between both groups.
Measured: Six months
Financial cost between both groups.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Feb 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Hydatid CystStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483880
- Sponsor's protocol ID
- FMASU MS187/2024
- Status last verified
- Feb 2024
- First submitted
- 23 Jun 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18819855Aydin 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.
PubMed 34587626Dehkordi 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.
PubMed 29956639Fattahi 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.
PubMed 28319358Rawat 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.
PubMed 31681642Sarkar 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.
PubMed 27051107Teggi 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.
PubMed 8215283
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06483880
- Acronym / sponsor ID
- FMASU MS187/2024
- Conditions
- Pulmonary Hydatid Cyst
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albendazole arm | Active comparator | Drug: AlbendazoleThe 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 | Drug: PlaceboPatients will receive the placebo, which will be in two equally split doses per day. This is within two 15-day cycles following surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All patients regardless of age with pulmonary hydatid disease requiring surgical resection.
- Patients achieving complete resection of pulmonary hydatid disease.
- Patients with no extra pulmonary hydatid disease.
- Patients who have received preoperative albendazole.
Key exclusion criteria (6 listed)
- Patients with extra pulmonary hydatid disease requiring treatment after pulmonary resection.
- Patients with incomplete resection of pulmonary hydatid disease.
- Patients with pulmonary hydatid disease not amenable for resection.
- Patients with hypersensitivity to Albendazole.
- Patients with liver dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbendazolePatients will receive albendazole therapy at the recommended dosage. | Drug | Albendazole arm |
| PlaceboPatients will receive the placebo, which will be starch tablets in the same dosage of albendazole. | Drug | Placebo arm |
Primary outcome
Recurrence of pulmonary hydatid disease
Time frame: six months
Recurrence of pulmonary hydatid disease in six months in both groups, assessed by: 1. Chest X-ray radiography after the 2 weeks. 2. CT chest in six months and after one year or symptoms requiring CT chest at any timing.
4 secondary outcomes
Liver function tests (AST and ALT) between both groups.
Time frame: Six months
Length of hospital stay between both groups.
Time frame: Six months
In hospital mortality between both groups.
Time frame: Six months
Financial cost between both groups.
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Background: PubMed 18819855Arif 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.
- Background: PubMed 34587626Aydin 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.
- Background: PubMed 29956639Dehkordi 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.
- Background: PubMed 28319358Fattahi 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.
- Background: PubMed 31681642Rawat 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.
- Background: PubMed 27051107Sarkar 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.
- Background: PubMed 8215283Teggi 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albendazole in people with Pulmonary Hydatid Cyst, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of pulmonary hydatid disease (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06483880, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.