Bleomycin Intralesional Injections of Cystic Hygromas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-04-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Lymphatic Malformations

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intralesional Injections

Bleomycin Intralesional Injections

Group Type EXPERIMENTAL

Intralesional Injections

Intervention Type PROCEDURE

Intralesional Injections

Interventions

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Intralesional Injections

Intervention Type PROCEDURE

Eligibility Criteria

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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).