Enrolling by invitation NCT07240259
Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cryopreserved aorta.
- Who it may be relevant to
- Registry conditions: Trachea Diseases, Tracheal Stenosis, Tuberculosis; Tracheitis, Airway Disease. Basic parameters: 0 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Feasibility and safety of repairing tracheal and bronchial defects in infants and children using cryopreserved donor aortic patches.
Detailed description
This trial plans to use cryopreserved donor aortic tissue patches to repair and treat pediatric patients with end-stage, life-threatening or severely disabling tracheal diseases who have not responded to conventional conservative therapies or lack sufficient native tracheal tissue for tracheal defect reconstruction.
Interventions
- Procedure Cryopreserved aorta
After resection of the tracheal or bronchial lesion with standard surgical techniques, the airway gap is reconstructed with a segment 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.
Primary outcome measures
- 90-day Mortality [Time frame: Postoperative 90 days]
Secondary outcome measures (5)
- Anastomotic Leakage [Time frame: Within 90 days postoperatively]
- Pneumonia [Time frame: Within 90 days postoperatively]
- Difficult Extubation [Time frame: Within 90 days postoperatively]
- Granulation Tissue Obstruction [Time frame: Within 90 days postoperatively]
- Stenosis Caused by Scar Fibrosis and Related Complications [Time frame: Within 90 days postoperatively]
Eligibility criteria
Inclusion criteria
Meeting any of the following conditions, and being unsuitable for standard end-to-end tracheal anastomosis or lacking sufficient native tracheal tissue for defect reconstruction:
- Congenital tracheal malformations: including congenital tracheomalacia, congenital tracheobronchial anomalies, complete tracheal rings, etc., with severe clinical respiratory symptoms and recommended for treatment after evaluation.
- Acquired tracheal stenosis: including tracheal narrowing caused by disease, endotracheal intubation, or postoperative scar formation, with severe clinical respiratory symptoms and recommended for treatment after evaluation.
- Tracheal injury or tissue loss due to trauma or burns requiring surgical repair.
- Tracheal tumors: reconstruction of tracheal tissue after resection of benign or malignant tumors.
- The term "severe clinical respiratory symptoms" includes:
- Dependence on mechanical ventilation for more than 1 month due to airway narrowing or defect, with inability to wean.
- Airway stenosis exceeding 50% (confirmed by bronchoscopy or CT imaging), accompanied by persistent stridor, inspiratory dyspnea, or suprasternal/substernal retractions, causing impairment of daily activities or feeding difficulties.
- Unilateral or bilateral lung atelectasis persisting for more than 1 month due to tracheal or bronchial stenosis, with no sign of recovery.
- Recurrent post-obstructive pneumonia (≥3 episodes) in one or both lungs caused by tracheal or bronchial stenosis, requiring hospitalization for treatment.
Exclusion criteria
- Inability to obtain legal informed consent from the lawful guardian.
- Locally invasive tracheal tumors that cannot be completely resected surgically.
- Malignant solid tumors with distant metastases that cannot be completely resected surgically or controlled with medication.
- Presence of severe immunodeficiency (e.g., congenital immunodeficiency, HIV infection, ongoing chemotherapy, or recovery period after bone marrow transplantation).
- Presence of major congenital diseases or chromosomal abnormalities (e.g., Trisomy 13, Trisomy 18) with extremely poor prognosis as assessed clinically.
- End-stage organ failure (e.g., persistent multiple organ failure, irreversible cardiopulmonary failure, or brain death).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taiwan National Taiwan University Hospital — Taipei
Publications
- Tsou KC, Hung WT, Ju YT, Liao HC, Hsu HH, Chen JS. Application of aortic allograft in trachea transplantation. J Formos Med Assoc. 2023 Sep;122(9):940-946. doi: 10.1016/j.jfma.2023.03.006. Epub 2023 Mar 29. PMID 37002174
- Lu CW, Liao HC, Tsou KC, Hung WT, Huang PM, Hsu HH, Chen JS. Cryopreserved aortic graft patch repair of traumatic tracheal rupture defect: A case report. JTCVS Tech. 2024 Aug 17;27:182-184. doi: 10.1016/j.xjtc.2024.07.023. eCollection 2024 Oct. No abstract available. PMID 39478918
- Hung WT, Liao HC, Hsu HH, Chen JS. Stented cryopreserved aortic allograft for reconstruction of long-segment post-tuberculosis tracheal stenosis. J Formos Med Assoc. 2024 Jul;123(7):818-820. doi: 10.1016/j.jfma.2024.03.006. Epub 2024 Mar 16. PMID 38494361
Identifiers
NCT: NCT07240259 · 202404094DINC