NCT04850742Unknown不适用
Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- 90-day mortality
研究概览
简要总结
We used a segment of cryopreserved aorta as a graft for reconstruction for long segment tracheobronchial lesion in human.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced benign or malignant lesions involving trachea or bronchi, and has failed conventional treatment.
- •Patients with proximal pulmonary tumors that require surgical resection and has involved proximal airways which is indicated for a pneumonectomy, sleeve lobectomy, or carina resection.
排除标准
- •Less than 20-year-old
- •Unable to obtain informed consent.
- •Pulmonary tumors that can be treated with standard lobectomy.
- •Unresectable locally advanced malignant tumors
- •Malignant tumors with contralateral lymph nodes involvement.
- •Malignant tumors with distal metastases; except for simple resectable brain metastasis.
- •Tracheal lesions which can be treated with standard resection and direct anastomosis.
- •Allergic to iodine
- •Unable to tolerate standard lobectomy
- •Has human immunodeficiency virus infection
- •Tracheal stenosis at proximal 2 cm on upper trachea
研究组 & 干预措施
Cryopreserved aorta
Experimental
After resection of a segment of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft.
干预措施: Cryopreserved aorta (Procedure)
结局指标
主要结局
90-day mortality
时间窗: 90 days
The rate of death at 90 days.
次要结局
- 90-day morbidity(90 days)
研究者
研究点 (1)
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