NCT06935110招募中不适用
Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- 90-day mortality
研究概览
简要总结
The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.
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
- •Congenital tracheal deformities: Includes congenital tracheomalacia, congenital tracheobronchial malformations, complete tracheal rings, etc., with severe clinical symptoms and cases where treatment is recommended after evaluation.
- •Acquired tracheal stenosis: Includes tracheal narrowing caused by diseases, endotracheal intubation, or postoperative scar tissue, with severe clinical symptoms and cases where treatment is recommended after evaluation.
- •Tracheal injury or tissue defect caused by trauma or burns: Cases requiring surgical repair.
- •Tracheal tumors: Reconstruction of tracheal tissue following the removal of benign or malignant tumors.
排除标准
- •Patients who are unable to provide informed consent.
- •Pulmonary tumors that can be treated with standard lobectomy.
- •Locally invasive tumors that are unresectable.
- •Presence of contralateral lymph node metastasis.
- •Presence of distant metastasis, except for solitary, resectable brain metastasis.
- •Tracheal lesions amenable to standard resection with direct anastomosis.
- •Preoperative evaluation indicates inability to undergo standard lobectomy.
- •Patients infected with human immunodeficiency virus (HIV) or with other immunodeficiency disorders.
- •Any condition or circumstance deemed by the principal investigator to potentially interfere with the conduct of the trial (e.g., severely impaired cardiopulmonary function, significant liver or kidney dysfunction, poorly controlled diabetes, high-risk groups, or pregnancy).
- •Individuals with concerns about the potential risks of the trial.
研究组 & 干预措施
Cryopreserved aortic patch
Experimental
Using the cryopreserve aortic patch to repair the tracheobronchial defect.
干预措施: Cryopreserved aortic patch (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 (2)
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