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Recruiting

NCT Number: NCT06935110

Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch

The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital, Taipei, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.
  • Tracheal injury or tissue defect caused by trauma or burns: Cases requiring surgical repair.
  • Tracheal tumors: Reconstruction of tracheal tissue following the removal of benign or malignant tumors.

Exclusion criteria

  • Patients who are unable to provide informed consent.
  • Pulmonary tumors that can be treated with standard lobectomy.
  • Locally invasive tumors that are unresectable.
  • Presence of contralateral lymph node metastasis.
  • Presence of distant metastasis, except for solitary, resectable brain metastasis.
  • Tracheal lesions amenable to standard resection with direct anastomosis.
  • Preoperative evaluation indicates inability to undergo standard lobectomy.
  • Patients infected with human immunodeficiency virus (HIV) or with other immunodeficiency disorders.
  • 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).
  • Individuals with concerns about the potential risks of the trial.

Treatment and study plan

Cryopreserved aortic patch

Procedure

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.

Primary outcomes

  1. 90-day mortality

    Time frame: 90 days

    The rate of death at 90 days.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao-Wen Lu, MD

CONTACT

[email protected]

+886972652324

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 20, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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