Cryoablation of Venous Vascular Malformations Located in Soft Tissues
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- To evaluate the safety of cryoablation by measuring the immediate complications using NCI-CTCAE toxicity scale.
研究概览
简要总结
To now, two alternatives for the management of venous vascular malformations are recognized, appropriate to the location, size and patients: sclerosis and surgery. However, sclerosis is effective on symptoms in 80% of cases and excision removes the malformation completely or partially, but it is aggressive and recurrences are common.
详细描述
In order to propose an additional alternative option, cryoablation has been recently tested with promising results. Therefore, the purpose of this study is to evaluate the safety and efficacy of cryotherapy on venous vascular malformations.
Fourteen patients will be included after discussion in multidisciplinary meeting. Patients will be follow until 6 months to evaluate the safety and the 6 months efficacy on symptoms. A MRI will be perform at 6 months to evaluate the size of ablated zone following RECIST criteria.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years,
- •Initial radiological diagnosis of venous or glomovenous vascular malformation proved by Doppler ultrasound and MRI,
- •Recurrence of symptoms after initial treatment,
- •Symptomatic deformation :pain, tangible mass,functional discomfort
- •Recurrence after treatment by surgery or sclerosis
- •Cryotherapy considered technically feasible after discussion in multidisciplinary committee,
- •Localization at distance from the skin and major neurovascular structures,
- •Absence of contra-indication of anaesthesia,
- •Signed informed consent,
- •Coverage by French social security
排除标准
- •Localization of the lesion does not allow the implementation of cryotherapy in adequate conditions: ablation zone too close to the major anatomic structures (nerve),
- •TP <50% TCA> 1.5 x control, anticoagulation
- •Platelets <90000/mm3,
- •Progressive infection
- •Patient included in another clinical study,
- •Unable to undergo medical tests for geographical, social or psychological,
- •Adult under a legal guardianship or unable to consent,
- •Pregnancy and breastfeeding.
研究组 & 干预措施
only one treatment group
Patients presenting inoperable venous vascular malformations in soft tissues with indication of cryoablation.
干预措施: Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles) (Device)
结局指标
主要结局
To evaluate the safety of cryoablation by measuring the immediate complications using NCI-CTCAE toxicity scale.
时间窗: 7 days after cryoablation
To evaluate the safety of cryoablation by measuring the late complications using NCI-CTCAE toxicity scale.
时间窗: 6 months after cryoablation
To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale.
时间窗: 2 months after cryoablation
次要结局
- Imaging response (RECIST 1.1)(6 months after cryoablation)
- Quality of life using QLQ-C30(2 months & 6 months after cryoablation)
- All adverse events using NCI-CTCAE(7 days, 1 month ,2 months + 6 months after cryoablation)
- Clinical response (decrease of pain and/or functional discomfort)(6 months after cryoablation)
- Pain using visual analogue scale(7 days, 1 month ,2 months & 6 months after cryoablation)