Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children

N/AEnrolling By InvitationNCT07240259

National Taiwan University Hospital5 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Cryopreserved aortaPROCEDURE

After resection of the tracheal or bronchial lesion with standard surgical techniques, the airway gap is reconstructed with a segment of human cryopreserved (-80 celsius degree) aortic allograft, which was not matched by the ABO and leukocyte antigen systems. The anastomosis is performed with standard technique for airway anastomosis.

Eligibility

Sex: ALLMin age: 0 YearsMax age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Taiwan National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

90-day Mortality

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.

Time frame: Postoperative 90 days