An interventional study of Intralesional Injections in Lymphatic Malformations, sponsored by Delta University for Science and Technology. Completed at 1 site in Egypt. Open to participants aged 1 Month to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Delta University for Science and Technology · Not applicable, Interventional, and Treatment
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).
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.
42 studies on the registry are indexed under Lymphatic Abnormalities; 17 are open to participants now.
This study's enrollment of 30 is below the median of 46 across 28 interventional studies indexed under Lymphatic Abnormalities.
Browse Lymphatic Abnormalities studies →Delta University for Science and Technology is the lead sponsor of 86 studies on the registry; 16 are open to participants now.
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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).
Bleomycin Intralesional Injections
Procedure: Intralesional Injections
Intralesional Injections
improvement
change of lesion size
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2024 to primary completion in Apr 2025, 7 months.
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Delta University for Science and Technology