By InvitationNot Applicable

Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children

Taiwan5 participantsStarted 2025-06-09

Plain-language summary

Feasibility and safety of repairing tracheal and bronchial defects in infants and children using cryopreserved donor aortic patches.

Age range0 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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).

90-day Mortality

Timeframe: Postoperative 90 days

NCT IDNCT07240259

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-31

Who can participate

Age range0 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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).