Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch

November 25, 2025 updated by: National Taiwan University Hospital
The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Not yet recruiting
        • National Taiwan University Hospital
        • Contact:
          • Jin-Shing Chen, MD, PhD
          • Phone Number: 02-23123456 Ext. 65178
          • Email: chenjs@ntu.edu.tw
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Congenital tracheal deformities: Includes congenital tracheomalacia, congenital tracheobronchial malformations, complete tracheal rings, etc., with severe clinical symptoms and cases where treatment is recommended after evaluation.
  2. Acquired tracheal stenosis: Includes tracheal narrowing caused by diseases, endotracheal intubation, or postoperative scar tissue, with severe clinical symptoms and cases where treatment is recommended after evaluation.
  3. Tracheal injury or tissue defect caused by trauma or burns: Cases requiring surgical repair.
  4. Tracheal tumors: Reconstruction of tracheal tissue following the removal of benign or malignant tumors.

Exclusion Criteria:

  1. Patients who are unable to provide informed consent.
  2. Pulmonary tumors that can be treated with standard lobectomy.
  3. Locally invasive tumors that are unresectable.
  4. Presence of contralateral lymph node metastasis.
  5. Presence of distant metastasis, except for solitary, resectable brain metastasis.
  6. Tracheal lesions amenable to standard resection with direct anastomosis.
  7. Preoperative evaluation indicates inability to undergo standard lobectomy.
  8. Patients infected with human immunodeficiency virus (HIV) or with other immunodeficiency disorders.
  9. Any condition or circumstance deemed by the principal investigator to potentially interfere with the conduct of the trial (e.g., severely impaired cardiopulmonary function, significant liver or kidney dysfunction, poorly controlled diabetes, high-risk groups, or pregnancy).
  10. Individuals with concerns about the potential risks of the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryopreserved aortic patch
Using the cryopreserve aortic patch to repair the tracheobronchial defect.
Procedure: Cryopreserved aortic patch
After identifying the tracheal or bronchial defect with standard surgical techniques, the airway gap is reconstructed with a patch 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 silicon stent is inserted to prevent collapse for the aortic graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
90-day mortality
Time Frame: 90 days
The rate of death at 90 days.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
90-day morbidity
Time Frame: 90 days
The occurrence of complication including 1) anastomotic leakage, 2) pneumonia, 3) difficult weaning, 4) airway obstruction by granulation tissue, 5) stenosis.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Jin-Shing Chen, MD, PhD, National Taiwan University Hospital, Taipei, 100

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

April 11, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202407061DINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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