Endoscopic Treatment With 3D Customized Versus Standard Stent for Non-malignant Airway Stenoses: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 试验地点
- 6
- 主要终点
- Rate of patients (Cox model) experiencing one or more severe stent and/or procedure-related complication(s)
研究概览
简要总结
The placement of an endoprosthesis in the airways leads to rapid and dramatic clinical improvement in the majority of cases of central airway obstruction. However, the limited diversity of device shapes available on the market is a major limitation, as these devices are poorly adapted, or not adapted at all, to the patient's anatomy. The main consequences of this lack of congruity are stent migration and granulomatous inflammatory reactions. The investigators hypothesized that personalized endoprostheses could significantly reduce the complication rate and improve tolerability. In this randomized controlled trial, the investigators propose to evaluate whether personalized endoprostheses allow for better management of non-malignant central airway stenoses by comparing this new approach to standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Age >18 years,
- •Central non-malignant symptomatic (dyspnea > grade 2 mMRC or post-stenotic infection) airway stenosis with silicone stent implantation indication (viable downstream airways, pulmonary artery and parenchyma),
- •To have access to a personal telephone for the teleconsultation scheduled in the protocol,
- •Informed consent signed,
- •Health insurance beneficiary.
排除标准
- •Acute respiratory distress,
- •Mechanical ventilation,
- •Contraindication to rigid bronchoscopy: severe coagulation disorders that cannot be corrected, anticoagulant or antiplatelet therapy other than aspirin within 5 days prior to the stent implantation,
- •Malignant stenosis,
- •Pregnancy or breast-feeding,
- •A situation in which emergency or semi-emergency intervention (less than 48 hours) may be anticipated (like an acute respiratory distress for example),
- •Patient under legal protection, - Participation in another study with an exclusion period still in progress,
- •Impossibility of giving the person informed information and of ensuring the subject's compliance due to impaired physical and/or psychological health.
结局指标
主要结局
Rate of patients (Cox model) experiencing one or more severe stent and/or procedure-related complication(s)
时间窗: 47 months
Rate of patients (Cox model) experiencing one or more severe stent and/or procedure-related complication(s)
次要结局
- Change in pulmonary function tests(15 months)
- Rate (percent) of all adverse events(15 months)
- Evolution in dyspnea(15 months)
- Evolution of quality of life(15 months)