Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch
National Taiwan University Hospital
10 participants
Sep 15, 2025
INTERVENTIONAL
Conditions
Summary
The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.
Eligibility
Inclusion Criteria4
- 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.
- 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.
- Tracheal injury or tissue defect caused by trauma or burns: Cases requiring surgical repair.
- Tracheal tumors: Reconstruction of tracheal tissue following the removal of benign or malignant tumors.
Exclusion Criteria10
- Patients who are unable to provide informed consent.
- Pulmonary tumors that can be treated with standard lobectomy.
- Locally invasive tumors that are unresectable.
- Presence of contralateral lymph node metastasis.
- Presence of distant metastasis, except for solitary, resectable brain metastasis.
- Tracheal lesions amenable to standard resection with direct anastomosis.
- Preoperative evaluation indicates inability to undergo standard lobectomy.
- Patients infected with human immunodeficiency virus (HIV) or with other immunodeficiency disorders.
- 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).
- Individuals with concerns about the potential risks of the trial.
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Interventions
After identifying the tracheal or bronchial defect with standard surgical techniques, the airway gap is reconstructed with a patch 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. An silicon stent is inserted to prevent collapse for the aortic graft.
Locations(2)
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NCT06935110