Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children

National Taiwan University

Status: Invitation-only

Conditions: Airway Disease; Trachea Diseases; Tracheal Stenosis; Tracheal Stenosis Following Tracheostomy; Tracheomalacia; Tracheal Reconstruction Surgery; Tuberculosis; Tracheitis

Treatments: Procedure: Cryopreserved aorta

Study type: Interventional

Funder types: Other

Identifiers

NCT07240259

202404094DINC

Details and patient eligibility

About

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

Full description

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.

Enrollment: 5 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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:

1. Congenital tracheal malformations: including congenital tracheomalacia, congenital tracheobronchial anomalies, complete tracheal rings, etc., with severe clinical respiratory symptoms and recommended for treatment after evaluation.

2. 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.

3. Tracheal injury or tissue loss due to trauma or burns requiring surgical repair.

4. Tracheal tumors: reconstruction of tracheal tissue after resection of benign or malignant tumors.

5. The term "severe clinical respiratory symptoms" includes:

   1. Dependence on mechanical ventilation for more than 1 month due to airway narrowing or defect, with inability to wean.
   2. 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.
   3. Unilateral or bilateral lung atelectasis persisting for more than 1 month due to tracheal or bronchial stenosis, with no sign of recovery.
   4. Recurrent post-obstructive pneumonia (≥3 episodes) in one or both lungs caused by tracheal or bronchial stenosis, requiring hospitalization for treatment.

Exclusion criteria

1. Inability to obtain legal informed consent from the lawful guardian.
2. Locally invasive tracheal tumors that cannot be completely resected surgically.
3. Malignant solid tumors with distant metastases that cannot be completely resected surgically or controlled with medication.
4. Presence of severe immunodeficiency (e.g., congenital immunodeficiency, HIV infection, ongoing chemotherapy, or recovery period after bone marrow transplantation).
5. Presence of major congenital diseases or chromosomal abnormalities (e.g., Trisomy 13, Trisomy 18) with extremely poor prognosis as assessed clinically.
6. End-stage organ failure (e.g., persistent multiple organ failure, irreversible cardiopulmonary failure, or brain death).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Cryopreserved aorta

Experimental group

Description:

After resection of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft.

Treatment:

Procedure: Cryopreserved aorta