The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection

February 14, 2025 updated by: Ain Shams University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al Abbasiya
      • Cairo, Al Abbasiya, Egypt
        • Recruiting
        • Ain shams university hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Albendazole arm
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.
Drug: Albendazole
Patients will receive albendazole therapy at the recommended dosage.
Placebo Comparator: Placebo arm
Patients will receive the placebo, which will be in two equally split doses per day. This is within two 15-day cycles following surgery.
Drug: Placebo
Patients will receive the placebo, which will be starch tablets in the same dosage of albendazole.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver function tests (AST and ALT) between both groups.
Time Frame: Six months
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.
Time Frame: Six months
Six months
In hospital mortality between both groups.
Time Frame: Six months
Six months
Financial cost between both groups.
Time Frame: Six months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

June 23, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS187/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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