Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices

National Taiwan University Hospital5 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Trachea Diseases Tracheal Stenosis Lung Cancer Tuberculosis; Tracheitis Airway Disease

Interventions

Cryopreserved aortaPROCEDURE

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

90-day mortality

The rate of death at 90 days.

Time frame: 90 days

Secondary Outcomes

90-day morbidity

The occurrence of complication including 1) anastomotic leakage, 2) pneumonia, 3) difficult weaning, 4) airway obstruction by granulation tissue, 5) stenosis.

Time frame: 90 days

Data from ClinicalTrials.gov

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