Status:
RECRUITING
Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Trachea Diseases
Airway Remodeling
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06935110
Start Date
September 15 2025
End Date
October 1 2029
Last Update
December 3 2025
Active Locations (2)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100
2
National Taiwan University Hospital
Taipei, Taiwan