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Bleomycin Intralesional Injections of Cystic Hygromas

Bleomycin Intralesional Injections of Cystic Hygromas in Pediatric Patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07189832
Enrollment
30
Registered
2025-09-24
Start date
2024-09-01
Completion date
2025-04-01
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphatic Malformations

Keywords

Bleomycin, Cervico-facial, Cystic Hygroma, Lymphatic Malformation

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.

Interventions

PROCEDUREIntralesional Injections

Intralesional Injections

Sponsors

Delta University for Science and Technology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

pediatric patients of age up to 12 years having Cervicofacial cystic hygromas

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Years
Healthy volunteers
Yes

Inclusion criteria

Clinical diagnosis of Cervicofacial cystic hygromas (macrocystic lymphatic malformations) Pediatric patients from age 1 month to 12 years, recruited from the vascular anomalies clinic at the pediatric surgery department in Cairo University Specialized Pediatric Hospital (Abu EL-Reesh hospital).

Design outcomes

Primary

MeasureTime frameDescription
improvement6 monthschange of lesion size

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026