Efficacy and Safety of Different Concentrations of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients

What this Trial Is About

Lymphatic malformations (LMs) are vascular anomalies caused by abnormal development of the lymphatic system, often appearing as dilated lymphatic channels or cysts. These malformations commonly occur in the head, neck, and axilla areas, and can cause symptoms ranging from none at all to serious complications such as pain, infection, or organ compression. Surgical removal can be challenging and risky due to the nature of the lesions. This research aims to compare the effectiveness and safety of different concentrations of Bleomycin, a drug used in sclerotherapy, for treating LMs in children. Participants will receive sclerotherapy treatment with Bleomycin at either low-dose (1 mg/ml) or high-dose (2 mg/ml) concentrations through intracapsular injections. This randomized, double-blind study evaluates these two dosing groups to determine which concentration is better for pediatric patients with LMs that cannot be fully removed surgically. The trial is designed as a Phase 2 study focusing on the dose-dependent effects of Bleomycin. During the 3 to 6 months following treatment, researchers will measure changes in the volume of lymphatic malformations as the primary outcome. Secondary assessments will include pain levels, overall treatment effectiveness, quality of life, and safety monitoring. Pediatric participants and their guardians will provide consent or assent, and the study includes imaging evaluations and symptom tracking to support the analysis of treatment impact.

Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients