Trattamento Delle Malformazioni Venose a Basso Flusso Con l'Elettroscleroterapia. Studio Osservazionale Prospettico
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Volume reduction in cm
研究概览
简要总结
Venous malformations (MVs) are congenital abnormalities of the central or periphery caused by developmental errors at different stages of embryogenesis. Histologically they are characterized by large, venous-like vascular spaces. Scleroembolization constitutes the most widespread method in the treatment of venous malformations allowing good results with low invasiveness. Currently, Bleomycin (and its derivatives) is among the most widely used sclerosing agents for slow-flowing vascular malformations (venous and lymphatic malformations) because of the low rate of local serious adverse events such as swelling, necrosis, and nerve injury compared with others.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of low-flow venous malformations eligible for electrosclerotherapy
- •Non-indication for embolizing treatment
- •Previous treatments are not an exclusion factor, provided that at least 30 days have elapsed.
排除标准
- •Previous treatment for < 30 days
- •Pregnancy and lactation status
- •Patients of childbearing age without contraceptive use
- •Presence of metal synthetic media
- •COPD with FiO2 < 30 mmHg
- •Impaired renal function with eGFR<30 ml/min/1.73mq
- •Patients with Bleomycin intolerance or previous episodes of toxicity Bleomycin-related
- •Patients who have already received a cumulative dose of Bleomycin ≥100 mg
- •Patients who have undergone prior thoracic radiotherapy
- •Patients with a history of seizures and epilepsy
研究组 & 干预措施
Performed electrosclerotherapy
All patients who performed electrosclerotherapy in the treatment of vascular malformations
干预措施: Bleomycin (Drug)
结局指标
主要结局
Volume reduction in cm
时间窗: 1 year
Reduction of the lesion of at least 30% evaluated with MRI, measuring the diameter of the lesion in cm.
次要结局
- Reduction of pain (VAS score)(1 year)
- Improvement in quality of life ( EuroQol-5D questionnaire)(1 year)