Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04850742

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Trachea Diseases Tracheal Stenosis Lung Cancer Tuberculosis; Tracheitis Airway Disease	Procedure: Cryopreserved aorta	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cryopreserved aorta After resection of a segment of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft.	Procedure: Cryopreserved 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.

Arm

Intervention/Treatment

Experimental: Cryopreserved aorta

After resection of a segment of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft.

Procedure: Cryopreserved 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.

Outcome Measures

Primary Outcome Measures

90-day mortality [90 days]
The rate of death at 90 days.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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