Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital
About this trial
The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Cryopreserved aortic patch
Procedure/SurgeryAfter 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Cryopreserved aortic patchExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
90-day mortality
The rate of death at 90 days.
Time frame
90 daysSecondary outcomes
1
90-day morbidity
The occurrence of complication including 1) anastomotic leakage, 2) pneumonia, 3) difficult weaning, 4) airway obstruction by granulation tissue, 5) stenosis.
Time frame
90 daysSponsors and contacts
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Source ClinicalTrials.gov