Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2024-03-31

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.

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Detailed Description

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Conditions

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Trachea Diseases Tracheal Stenosis Lung Cancer Tuberculosis; Tracheitis Airway Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cryopreserved aorta

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

Group Type EXPERIMENTAL

Cryopreserved aorta

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No