Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices

Study Overview
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Brief Summary
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We used a segment of cryopreserved aorta as a graft for reconstruction for long segment tracheobronchial lesion in human.

Official Title
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Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices

Conditions
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Lung Cancer, Trachea Diseases, Tracheal Stenosis, Tuberculosis; Tracheitis, Airway Disease

Intervention / Treatment
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* Procedure: Cryopreserved aorta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryopreserved aorta<br>After resection of a segment of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft. | Procedure: Cryopreserved aorta<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day mortality | The rate of death at 90 days. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day morbidity | The occurrence of complication including 1) anastomotic leakage, 2) pneumonia, 3) difficult weaning, 4) airway obstruction by granulation tissue, 5) stenosis. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tracheal reconstruction, bronchial reconstruction, cryopreserved aorta