Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children

NCT ID: NCT07240259

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-09
• Study Completion Date: 2028-01-31

Brief Summary

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

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cryopreserved aorta

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

Group Type: EXPERIMENTAL

Cryopreserved aorta

Intervention Type: PROCEDURE

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.

Interventions

Cryopreserved aorta

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taiwan National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

References

Tsou KC, Hung WT, Ju YT, Liao HC, Hsu HH, Chen JS. Application of aortic allograft in trachea transplantation. J Formos Med Assoc. 2023 Sep;122(9):940-946. doi: 10.1016/j.jfma.2023.03.006. Epub 2023 Mar 29.

Reference Type: BACKGROUND

PMID: 37002174 (View on PubMed)

Lu CW, Liao HC, Tsou KC, Hung WT, Huang PM, Hsu HH, Chen JS. Cryopreserved aortic graft patch repair of traumatic tracheal rupture defect: A case report. JTCVS Tech. 2024 Aug 17;27:182-184. doi: 10.1016/j.xjtc.2024.07.023. eCollection 2024 Oct. No abstract available.

Reference Type: BACKGROUND

PMID: 39478918 (View on PubMed)

Hung WT, Liao HC, Hsu HH, Chen JS. Stented cryopreserved aortic allograft for reconstruction of long-segment post-tuberculosis tracheal stenosis. J Formos Med Assoc. 2024 Jul;123(7):818-820. doi: 10.1016/j.jfma.2024.03.006. Epub 2024 Mar 16.

Reference Type: BACKGROUND

PMID: 38494361 (View on PubMed)

Other Identifiers

202404094DINC

Identifier Type: -

Identifier Source: org_study_id