Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Tracheal Stenosis; Airway Disease; Tracheomalacia; Trachea Diseases; Tuberculosis; Tracheitis; Tracheal Reconstruction Surgery; Tracheal Stenosis Following Tracheostomy
• Intervention / Treatment: Procedure: Cryopreserved aorta

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.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taiwan National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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:

1. Congenital tracheal malformations: including congenital tracheomalacia, congenital tracheobronchial anomalies, complete tracheal rings, etc., with severe clinical respiratory symptoms and recommended for treatment after evaluation.
2. 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.
3. Tracheal injury or tissue loss due to trauma or burns requiring surgical repair.
4. Tracheal tumors: reconstruction of tracheal tissue after resection of benign or malignant tumors.

5. The term "severe clinical respiratory symptoms" includes:

   1. Dependence on mechanical ventilation for more than 1 month due to airway narrowing or defect, with inability to wean.
   2. 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.
   3. Unilateral or bilateral lung atelectasis persisting for more than 1 month due to tracheal or bronchial stenosis, with no sign of recovery.
   4. Recurrent post-obstructive pneumonia (≥3 episodes) in one or both lungs caused by tracheal or bronchial stenosis, requiring hospitalization for treatment.

Exclusion Criteria:

1. Inability to obtain legal informed consent from the lawful guardian.
2. Locally invasive tracheal tumors that cannot be completely resected surgically.
3. Malignant solid tumors with distant metastases that cannot be completely resected surgically or controlled with medication.
4. Presence of severe immunodeficiency (e.g., congenital immunodeficiency, HIV infection, ongoing chemotherapy, or recovery period after bone marrow transplantation).
5. Presence of major congenital diseases or chromosomal abnormalities (e.g., Trisomy 13, Trisomy 18) with extremely poor prognosis as assessed clinically.
6. End-stage organ failure (e.g., persistent multiple organ failure, irreversible cardiopulmonary failure, or brain death).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryopreserved aorta; After resection of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic Leakage	Incidence of anastomotic leakage at the tracheal anastomosis site.	Within 90 days postoperatively
Pneumonia	Incidence of postoperative pneumonia.	Within 90 days postoperatively
Difficult Extubation	Occurrence of difficulties in extubation after surgery.	Within 90 days postoperatively
Granulation Tissue Obstruction	Incidence of airway obstruction due to granulation tissue formation.	Within 90 days postoperatively
Stenosis Caused by Scar Fibrosis and Related Complications	Occurrence of airway stenosis due to scar fibrosis or other related complications.	Within 90 days postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term Clinical Follow-up	Patients will undergo long-term follow-up including medical history review, physical examination, and imaging studies as clinically indicated (including but not limited to X-ray, CT scan, and bronchoscopy) to monitor long-term airway status and overall health.	At least 1 year postoperatively; infants and young children followed until at least puberty

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: September 12, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: tracheal stenosis; tracheal reconstruction; bronchial reconstruction; cryopreserved aorta; tracheomalacia
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Cartilage Diseases; Tracheobronchomalacia; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Tuberculosis; Tracheomalacia; Tracheal Diseases; Tracheal Stenosis; Tracheitis
• Other Study ID Numbers: 202404094DINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No