Bleomycin Intralesional Injections of Cystic Hygromas

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphatic Malformations Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hemic and Lymphatic Diseases Lymphangioma Lymphangioma, Cystic Lymphatic Abnormalities Lymphatic Diseases Neoplasm, Lymphatic Tissue Neoplasms Neoplasms by Histologic Type

Age range

1 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Specialized Pediatric Hospital (Abu EL-Reesh hospital)

Cairo, Cairo Governorate, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intralesional Injections

Procedure

Intralesional Injections

Primary outcomes

improvement

Time frame: 6 months

change of lesion size

Sponsors and collaborators

Lead sponsor

Delta University for Science and Technology

Other

Registry information

Official study title

Bleomycin Intralesional Injections of Cystic Hygromas in Pediatric Patients

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 24, 2025
Registry last updated: Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed