Back to resultsFeasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices
Primary Purpose
Trachea Diseases, Tracheal Stenosis, Lung Cancer
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Cryopreserved aorta
Sponsored by
About this trial
This is an interventional treatment trial for Trachea Diseases focused on measuring tracheal reconstruction, bronchial reconstruction, cryopreserved aorta
Eligibility Criteria
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
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cryopreserved aorta
Arm Description
After resection of a segment of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft.
Outcomes
Primary Outcome Measures
90-day mortality
The rate of death at 90 days.
Secondary Outcome Measures
90-day morbidity
The occurrence of complication including 1) anastomotic leakage, 2) pneumonia, 3) difficult weaning, 4) airway obstruction by granulation tissue, 5) stenosis.
Full Information
NCT ID
NCT04850742
First Posted
April 18, 2021
Last Updated
May 9, 2021
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04850742
Brief Title
Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices
Official Title
Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We used a segment of cryopreserved aorta as a graft for reconstruction for long segment tracheobronchial lesion in human.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trachea Diseases, Tracheal Stenosis, Lung Cancer, Tuberculosis; Tracheitis, Airway Disease
Keywords
tracheal reconstruction, bronchial reconstruction, cryopreserved aorta
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cryopreserved aorta
Arm Type
Experimental
Arm Description
After resection of a segment of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft.
Intervention Type
Procedure
Intervention Name(s)
Cryopreserved aorta
Intervention Description
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. An Ultraflex covered tracheobronchial stent is inserted to prevent collapse for the aortic graft.
Primary Outcome Measure Information:
Title
90-day mortality
Description
The rate of death at 90 days.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
90-day morbidity
Description
The occurrence of complication including 1) anastomotic leakage, 2) pneumonia, 3) difficult weaning, 4) airway obstruction by granulation tissue, 5) stenosis.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Shing Chen, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12735581
Citation
Martinod E, Seguin A, Pfeuty K, Fornes P, Kambouchner M, Azorin JF, Carpentier AF. Long-term evaluation of the replacement of the trachea with an autologous aortic graft. Ann Thorac Surg. 2003 May;75(5):1572-8; discussion 1578. doi: 10.1016/s0003-4975(03)00120-6.
Results Reference
background
PubMed Identifier
15734409
Citation
Martinod E, Seguin A, Holder-Espinasse M, Kambouchner M, Duterque-Coquillaud M, Azorin JF, Carpentier AF. Tracheal regeneration following tracheal replacement with an allogenic aorta. Ann Thorac Surg. 2005 Mar;79(3):942-8; discussion 949. doi: 10.1016/j.athoracsur.2004.08.035.
Results Reference
background
PubMed Identifier
19231406
Citation
Seguin A, Radu D, Holder-Espinasse M, Bruneval P, Fialaire-Legendre A, Duterque-Coquillaud M, Carpentier A, Martinod E. Tracheal replacement with cryopreserved, decellularized, or glutaraldehyde-treated aortic allografts. Ann Thorac Surg. 2009 Mar;87(3):861-7. doi: 10.1016/j.athoracsur.2008.11.038.
Results Reference
background
PubMed Identifier
29800033
Citation
Martinod E, Chouahnia K, Radu DM, Joudiou P, Uzunhan Y, Bensidhoum M, Santos Portela AM, Guiraudet P, Peretti M, Destable MD, Solis A, Benachi S, Fialaire-Legendre A, Rouard H, Collon T, Piquet J, Leroy S, Venissac N, Santini J, Tresallet C, Dutau H, Sebbane G, Cohen Y, Beloucif S, d'Audiffret AC, Petite H, Valeyre D, Carpentier A, Vicaut E. Feasibility of Bioengineered Tracheal and Bronchial Reconstruction Using Stented Aortic Matrices. JAMA. 2018 Jun 5;319(21):2212-2222. doi: 10.1001/jama.2018.4653.
Results Reference
background
PubMed Identifier
28109571
Citation
Martinod E, Paquet J, Dutau H, Radu DM, Bensidhoum M, Abad S, Uzunhan Y, Vicaut E, Petite H. In Vivo Tissue Engineering of Human Airways. Ann Thorac Surg. 2017 May;103(5):1631-1640. doi: 10.1016/j.athoracsur.2016.11.027. Epub 2017 Jan 18.
Results Reference
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Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices
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