Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children

NCT07240259 | Enrolling By Invitation DMC

• 1 other identifier: 202404094DINC
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility and safety of repairing tracheal and bronchial defects in infants and children using cryopreserved donor aortic patches.

Conditions

Trachea Diseases; Tracheal Stenosis; Tuberculosis; Tracheitis; Airway Disease; Tracheomalacia; Tracheal Stenosis Following Tracheostomy; Tracheal Reconstruction Surgery

Keywords

tracheomalacia; bronchial reconstruction; cryopreserved aorta; tracheal reconstruction; tracheal stenosis

Outcome Measures

Primary Outcomes (1)

• 90-day Mortality

  Survival status of patients within 90 days after surgery. This primary endpoint evaluates patient mortality, as patients undergoing this type of surgery often have a high short-term risk of death.

  Postoperative 90 days

Secondary Outcomes (5)

• Anastomotic Leakage

  Within 90 days postoperatively

• Pneumonia

  Within 90 days postoperatively

• Difficult Extubation

  Within 90 days postoperatively

• Granulation Tissue Obstruction

  Within 90 days postoperatively

• Stenosis Caused by Scar Fibrosis and Related Complications

  Within 90 days postoperatively

Other Outcomes (1)

• Long-term Clinical Follow-up

  At least 1 year postoperatively; infants and young children followed until at least puberty

Study Arms (1)

Cryopreserved aorta

EXPERIMENTAL

After resection of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft.

Procedure: Cryopreserved aorta

Interventions

Cryopreserved aorta PROCEDURE

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.

Cryopreserved aorta

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Taiwan National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Tracheal Diseases; Tracheal Stenosis; Tuberculosis; Tracheitis; Tracheomalacia

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Tracheobronchomalacia; Cartilage Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: November 20, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)