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Bleomycin Intralesional Injections of Cystic Hygromas

D

Delta University for Science and Technology

Status

Completed

Conditions

Lymphatic Malformations

Treatments

Procedure: Intralesional Injections

Study type

Interventional

Funder types

Other

Identifiers

NCT07189832
025081962

Details and patient eligibility

About

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).

Full 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.

Enrollment

30 patients

Sex

All

Ages

1 month to 12 years old

Volunteers

Accepts Healthy Volunteers

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).

Exclusion criteria

lung disease cardiac disease Liver disease kidney disease

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Intralesional Injections
Experimental group
Description:
Bleomycin Intralesional Injections
Treatment:
Procedure: Intralesional Injections

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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