Status:

UNKNOWN

Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices

Lead Sponsor:

National Taiwan University Hospital

Conditions:

Trachea Diseases

Tracheal Stenosis

Eligibility:

All Genders

20+ years

Phase:

NA

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 1 2024

    Estimated Enrollment :

    5 Patients enrolled

    Trial Details

    Trial ID

    NCT04850742

    Start Date

    January 1 2019

    End Date

    March 1 2024

    Last Update

    May 11 2021

    Active Locations (1)

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    1

    National Taiwan University Hospital

    Taipei, Taiwan, 100