Bleomycin Intralesional Injections of Cystic Hygromas

NCT07189832 | Completed

• 1 other identifier: 025081962
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Lymphatic Malformations

Keywords

Bleomycin, Cervico-facial, Cystic Hygroma, Lymphatic Malformation

Outcome Measures

Primary Outcomes (1)

• improvement

  change of lesion size

  6 months

Study Arms (1)

Intralesional Injections

EXPERIMENTAL

Bleomycin Intralesional Injections

Procedure: Intralesional Injections

Interventions

Intralesional Injections PROCEDURE

Intralesional Injections

Intralesional Injections

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

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

Cairo, Cairo Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Lymphatic Abnormalities; Lymphangioma, Cystic

Interventions

Injections, Intralesional

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

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

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 24, 2025
• Study Start: September 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 28, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)