Repairing tracheal and bronchial defects with a donated cryopreserved aortic patch

Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch

This test tries a donated cryopreserved aortic patch to repair tracheal or bronchial defects in people who need airway reconstruction after congenital problems, injury, or tumor removal.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 2 sites (Taipei and 1 other locations)
• Trial ID: NCT06935110 on ClinicalTrials.gov

What this trial studies

This single-center interventional program uses cryopreserved donor aortic patches as graft material to reconstruct defects of the trachea or bronchi. Eligible patients include those with severe congenital tracheal deformities, acquired tracheal stenosis, traumatic or burn-related airway defects, or tissue loss after tumor resection. Surgical implantation of the aortic patch will be followed by clinical assessment, imaging, and bronchoscopic exams to monitor healing, airway patency, and complications. The primary aim is to establish the safety and technical feasibility of this repair approach at National Taiwan University Hospital in Taipei.

Who should consider this trial

Good fit: Ideal candidates are adults or children with severe tracheal or bronchial defects from congenital malformations, post-intubation or disease-related stenosis, trauma or burns, or tissue loss after tumor removal who are recommended for surgical repair and can provide consent.

Not a fit: Patients with unresectable locally invasive tumors, contralateral lymph node involvement, distant metastases (except solitary resectable brain lesions), those who can be treated with standard lobectomy, or who cannot give informed consent are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, this approach could provide an alternative graft material to restore airway continuity and avoid more extensive reconstruction procedures.

How similar studies have performed: Use of cryopreserved vascular or aortic patches for airway reconstruction has appeared in limited case reports and small series with promising but preliminary results, so the approach remains relatively novel.

Eligibility criteria

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.

Where this trial is running

Taipei and 1 other locations

• National Taiwan University Hospital — Taipei, Taiwan (Not_yet_recruiting)
• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Jin-Shing Chen, MD, PhD — National Taiwan University Hospital, Taipei, 100
• Study coordinator: Chao-Wen Lu, MD

Conditions Trachea Diseases; Airway Remodeling; Reconstruction Surgery; cryopreserved aortic patch; airway repair; tracheal reconstruction; bronchial reconstruction