Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices

Not Applicable

• Conditions: Airway Disease; Trachea Diseases; Lung Cancer; Tracheal Stenosis; Tuberculosis; Tracheitis
• Interventions: Procedure: Cryopreserved aorta

• Registration Number: NCT04850742
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-18
• Study First Submitted QC: 2021-04-18
• Study First Posted: 2021-04-20
• Last Update Submitted: 2021-05-09
• Last Update Posted: 2021-05-11
• Primary Completion: 2023-12-31
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryopreserved aorta	Cryopreserved aorta	After resection of a segment of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft.

Primary Outcome Measures

Name	Time	Method
90-day mortality	90 days	The rate of death at 90 days.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan