Status:
COMPLETED
Bleomycin as an Effective and Curative Adjunct Therapy for Lymphangioma
Lead Sponsor:
National Children's Hospital, Vietnam
Conditions:
Lymphangioma
Lymphatic Malformations
Eligibility:
All Genders
Up to 18 years
Brief Summary
Lymphatic malformations (LM), or lymphangiomas, are common vascular anomalies in children, most often occurring in the head and neck, less commonly in the axilla, abdomen, thorax, groin, and extremiti...
Detailed Description
Lymphatic malformations (LM), often referred to as lymphangiomas, are a form of vascular malformation that arises due to the abnormal development of the lymphatic system. These benign but locally inva...
Eligibility Criteria
Inclusion
- Age: Pediatric patients under the age of 18 years.
- Diagnosis: Confirmed diagnosis of lymphangioma (lymphatic malformation).
- Location of Lesions: Lymphangiomas located in the head and neck, axilla, abdomen, thorax, groin, or extremities.
- Treatment History: No prior treatment with Bleomycin for lymphangioma.
- Health Status: No serious comorbidities or medical conditions that could interfere with the study or treatment process.
- Informed Consent: Patients (or their legal guardians) provide informed consent to participate in the study.
Exclusion
- Age: Patients over the age of 18 years.
- Pregnancy: Pregnant or breastfeeding patients.
- Other Treatments: Patients who have received prior treatments with Bleomycin for lymphangioma.
- Severe Comorbidities: Presence of serious comorbidities (e.g., uncontrolled cardiovascular disease, active infections) that may interfere with the study or treatment process.
- Allergy: Known allergy or hypersensitivity to Bleomycin or any of its components.
- Active Infections: Patients with active local or systemic infections at the time of enrollment.
- Immunosuppression: Immunocompromised patients (due to illness or medications).
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 4 2025
Estimated Enrollment :
809 Patients enrolled
Trial Details
Trial ID
NCT06943703
Start Date
January 1 2018
End Date
February 4 2025
Last Update
April 24 2025
Active Locations (1)
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1
Department of Surgery, The National Children Hospital, Hanoi
Hanoi, Vietnam