Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices

National Taiwan University

Status: Unknown

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

Treatments: Procedure: Cryopreserved aorta

Study type: Interventional

Funder types: Other

Identifiers

NCT04850742

201812035DINC

Details and patient eligibility

About

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

Enrollment: 5 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

Cryopreserved aorta

Experimental group

Description:

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

Treatment:

Procedure: Cryopreserved aorta