Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch

National Taiwan University

Status: Enrolling

Conditions: Trachea Diseases; Airway Remodeling; Reconstruction Surgery

Treatments: Procedure: Cryopreserved aortic patch

Study type: Interventional

Funder types: Other

Identifiers

NCT06935110

202407061DINE

Details and patient eligibility

About

The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Congenital tracheal deformities: Includes congenital tracheomalacia, congenital tracheobronchial malformations, complete tracheal rings, etc., with severe clinical symptoms and cases where treatment is recommended after evaluation.
2. Acquired tracheal stenosis: Includes tracheal narrowing caused by diseases, endotracheal intubation, or postoperative scar tissue, with severe clinical symptoms and cases where treatment is recommended after evaluation.
3. Tracheal injury or tissue defect caused by trauma or burns: Cases requiring surgical repair.
4. Tracheal tumors: Reconstruction of tracheal tissue following the removal of benign or malignant tumors.

Exclusion criteria

1. Patients who are unable to provide informed consent.
2. Pulmonary tumors that can be treated with standard lobectomy.
3. Locally invasive tumors that are unresectable.
4. Presence of contralateral lymph node metastasis.
5. Presence of distant metastasis, except for solitary, resectable brain metastasis.
6. Tracheal lesions amenable to standard resection with direct anastomosis.
7. Preoperative evaluation indicates inability to undergo standard lobectomy.
8. Patients infected with human immunodeficiency virus (HIV) or with other immunodeficiency disorders.
9. Any condition or circumstance deemed by the principal investigator to potentially interfere with the conduct of the trial (e.g., severely impaired cardiopulmonary function, significant liver or kidney dysfunction, poorly controlled diabetes, high-risk groups, or pregnancy).
10. Individuals with concerns about the potential risks of the trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Cryopreserved aortic patch

Experimental group

Description:

Using the cryopreserve aortic patch to repair the tracheobronchial defect.

Treatment:

Procedure: Cryopreserved aortic patch