Airway Disease, Lung Cancer, Trachea Diseases, Tracheal Stenosis, Tuberculosis; Tracheitis
Conditions
Keywords
tracheal reconstruction, bronchial reconstruction, cryopreserved aorta
Brief summary
We used a segment of cryopreserved aorta as a graft for reconstruction for long segment tracheobronchial lesion in human.
Interventions
PROCEDURECryopreserved aorta
After resection of the tracheal or bronchial lesion with standard surgical techniques, the airway gap is reconstructed with a segment 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 Ultraflex covered tracheobronchial 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
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with advanced benign or malignant lesions involving trachea or bronchi, and has failed conventional treatment. * Patients with proximal pulmonary tumors that require surgical resection and has involved proximal airways which is indicated for a pneumonectomy, sleeve lobectomy, or carina resection.
Exclusion criteria
* Less than 20-year-old * Unable to obtain informed consent. * Pulmonary tumors that can be treated with standard lobectomy. * Unresectable locally advanced malignant tumors * Malignant tumors with contralateral lymph nodes involvement. * Malignant tumors with distal metastases; except for simple resectable brain metastasis. * Tracheal lesions which can be treated with standard resection and direct anastomosis. * Allergic to iodine * Unable to tolerate standard lobectomy * Has human immunodeficiency virus infection * Tracheal stenosis at proximal 2 cm on upper trachea
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
Outcome results
None listed