Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to repair damaged areas of the trachea (the windpipe) and bronchial tubes using special patches made from donated aortic tissue that has been preserved. The goal is to see if these patches are safe and effective for patients who have serious breathing problems due to conditions like congenital deformities, injuries, or tumors. The trial is not yet recruiting participants, but it will involve individuals aged 65 to 74 who meet specific criteria.

To participate, patients may have severe breathing issues caused by conditions like tracheal narrowing from previous treatments or congenital malformations. However, not everyone will qualify; for example, patients with certain types of tumors that can be treated with standard surgery may be excluded. Those who take part in the trial can expect to receive care focused on repairing their tracheal damage, and they will be monitored closely for their safety throughout the study. It's important for potential participants to discuss any concerns about the trial risks with their healthcare provider before deciding to join.

Gender

ALL

Eligibility criteria

• 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.