Bleomycin Intralesional Injections of Cystic Hygromas in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- improvement
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •lung disease cardiac disease Liver disease kidney disease
研究组 & 干预措施
Intralesional Injections
Bleomycin Intralesional Injections
干预措施: Intralesional Injections (Procedure)
结局指标
主要结局
improvement
时间窗: 6 months
change of lesion size
improvement
时间窗: 6 months
change of lesion size
次要结局
未报告次要终点
研究者
Sarah Arafat
Lecturer
Delta University for Science and Technology