Bleomycin Intralesional Injections of Cystic Hygromas

Not Applicable

Completed

• Conditions: Management of Cystic Hygromas n Pediatric Patients

• Registration Number: NCT07189832
• Lead Sponsor: Delta University for Science and Technology

Brief Summary

Thirty pediatric patients with cystic hygromas participated in this study. The cystic fluid was aspirated from the cystic hygroma, and the lesion was simultaneously injected with Bleomycin. Then, the lesion was re-injected at 4-week intervals until satisfactory results were obtained. Clinical response was evaluated as complete response (\> 90% reduction of lesion size), marked improvement (\>70% reduction of lesion size), moderate improvement (40 - 70% reduction of lesion size), slight improvement (\< 40%), and no response (\< 10% reduction of lesion size).

Detailed Description

A total of 30 pediatric patients of age up to 12 years having Cervicofacial cystic hygromas (macrocystic lymphatic malformations) were chosen from the vascular anomalies clinic in Cairo University Specialized Pediatric Hospital (CUSPH). Diagnosis was accomplished by taking history from parents, clinical examination, and confirmed by ultrasonography (USG) and\\or magnetic resonance imaging (MRI) for deep lesions.

The procedure was explained in simple, clear words to the parents of each infant/child before the study, and an informed written consent was signed by each parent, containing treatment benefits, potential risks as outlined in the principles of Helsinki Declaration. Each infant/child was treated and followed up for 12 months after the last BLM intralesional injection.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01
• Study First Submitted: 2025-09-22
• Study First Submitted QC: 2025-09-22
• Last Update Submitted: 2025-09-22
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

pediatric patients of age up to 12 years having Cervicofacial cystic hygromas (macrocystic lymphatic malformations), from the vascular anomalies clinic at the pediatric surgery department in Cairo University Specialized Pediatric Hospital (Abu EL-Reesh hospital).

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Exclusion Criteria

pediatric patients with lung, liver, or kidney diseases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
improvement	6 months	reduction of lesion size

Trial Locations

Locations (1)

Cairo University Specialized Pediatric Hospital (Abu EL-Reesh hospital); 🇪🇬 Cairo, Cairo Governorate, Egypt