Using Cryopreserved Aortic Patches to Repair Tracheal and Bronchial Defects A Study on the Safety and Feasibility of Airway Reconstruction Surgery

What this Trial Is About

Researchers are studying the feasibility and safety of using cryopreserved human aortic patches to repair tracheal or bronchial defects. This treatment is being evaluated for patients with various tracheal conditions including congenital deformities, acquired stenosis, trauma-related injuries, and tumors requiring reconstruction. The study is an interventional trial focused on treatment and is sponsored by the National Taiwan University Hospital. Participants will undergo surgical repair where the tracheal or bronchial defect is reconstructed using a cryopreserved aortic allograft patch. This allograft is preserved at -80 degrees Celsius and is not matched by ABO or leukocyte antigen systems. Standard airway anastomosis techniques are used to attach the patch, and a silicon stent is inserted afterwards to prevent collapse of the graft. During the study, participants will be monitored for outcomes including mortality and morbidity within 90 days following the procedure. Researchers will assess safety and treatment feasibility through these measures. The total study period extends until October 2029, with primary outcome evaluation at 90 days post-treatment. Participants will receive follow-up care as part of the trial to track these results.

Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch