NCT07240259Enrolling By Invitation不适用
Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 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
Feasibility and safety of repairing tracheal and bronchial defects in infants and children using cryopreserved donor aortic patches.
详细描述
This trial plans to use cryopreserved donor aortic tissue patches to repair and treat pediatric patients with end-stage, life-threatening or severely disabling tracheal diseases who have not responded to conventional conservative therapies or lack sufficient native tracheal tissue for tracheal defect reconstruction.
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
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting any of the following conditions, and being unsuitable for standard end-to-end tracheal anastomosis or lacking sufficient native tracheal tissue for defect reconstruction:
- •Congenital tracheal malformations: including congenital tracheomalacia, congenital tracheobronchial anomalies, complete tracheal rings, etc., with severe clinical respiratory symptoms and recommended for treatment after evaluation.
- •Acquired tracheal stenosis: including tracheal narrowing caused by disease, endotracheal intubation, or postoperative scar formation, with severe clinical respiratory symptoms and recommended for treatment after evaluation.
- •Tracheal injury or tissue loss due to trauma or burns requiring surgical repair.
- •Tracheal tumors: reconstruction of tracheal tissue after resection of benign or malignant tumors.
- •The term "severe clinical respiratory symptoms" includes:
- •Dependence on mechanical ventilation for more than 1 month due to airway narrowing or defect, with inability to wean.
- •Airway stenosis exceeding 50% (confirmed by bronchoscopy or CT imaging), accompanied by persistent stridor, inspiratory dyspnea, or suprasternal/substernal retractions, causing impairment of daily activities or feeding difficulties.
- •Unilateral or bilateral lung atelectasis persisting for more than 1 month due to tracheal or bronchial stenosis, with no sign of recovery.
- •Recurrent post-obstructive pneumonia (≥3 episodes) in one or both lungs caused by tracheal or bronchial stenosis, requiring hospitalization for treatment.
排除标准
- •Inability to obtain legal informed consent from the lawful guardian.
- •Locally invasive tracheal tumors that cannot be completely resected surgically.
- •Malignant solid tumors with distant metastases that cannot be completely resected surgically or controlled with medication.
- •Presence of severe immunodeficiency (e.g., congenital immunodeficiency, HIV infection, ongoing chemotherapy, or recovery period after bone marrow transplantation).
- •Presence of major congenital diseases or chromosomal abnormalities (e.g., Trisomy 13, Trisomy 18) with extremely poor prognosis as assessed clinically.
- •End-stage organ failure (e.g., persistent multiple organ failure, irreversible cardiopulmonary failure, or brain death).
研究组 & 干预措施
Cryopreserved aorta
Experimental
After resection 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: Postoperative 90 days
Survival status of patients within 90 days after surgery. This primary endpoint evaluates patient mortality, as patients undergoing this type of surgery often have a high short-term risk of death.
次要结局
- Anastomotic Leakage(Within 90 days postoperatively)
- Difficult Extubation(Within 90 days postoperatively)
- Pneumonia(Within 90 days postoperatively)
- Granulation Tissue Obstruction(Within 90 days postoperatively)
- Stenosis Caused by Scar Fibrosis and Related Complications(Within 90 days postoperatively)
研究者
研究点 (1)
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