Airway Remodeling, Reconstruction Surgery, Trachea Diseases
Conditions
Keywords
cryopreserved aortic patch, airway repair, tracheal reconstruction, bronchial reconstruction
Brief summary
The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.
Interventions
PROCEDURECryopreserved aortic patch
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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day mortality | 90 days | The rate of death at 90 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90-day morbidity | 90 days | The occurrence of complication including 1) anastomotic leakage, 2) pneumonia, 3) difficult weaning, 4) airway obstruction by granulation tissue, 5) stenosis. |
Countries
Taiwan
Contacts
CONTACTChao-Wen Lu, MD
PRINCIPAL_INVESTIGATORJin-Shing Chen, MD, PhD
National Taiwan University Hospital, Taipei, 100
Outcome results
None listed