Trachea DiseasesNCT04850742
Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices
A study testing Cryopreserved aorta in people with Trachea Diseases and Tracheal Stenosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
We used a segment of cryopreserved aorta as a graft for reconstruction for long segment tracheobronchial lesion in human. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Trachea Diseases, Tracheal Stenosis, Lung Cancer
- What is being tested?
- Cryopreserved aorta
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2019to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
We used a segment of cryopreserved aorta as a graft for reconstruction for long segment tracheobronchial lesion in human.
- Conditions
- Trachea Diseases, Tracheal Stenosis, Lung Cancer, Tuberculosis; Tracheitis, Airway Disease
- Being tested
- Cryopreserved aorta
- Keywords
- tracheal reconstruction, bronchial reconstruction, cryopreserved aorta
- Medical subject headings
- Tracheal Diseases, Tracheal Stenosis, Lung Neoplasms, Tuberculosis, Tracheitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryopreserved aortaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cryopreserved aorta | Experimental | After resection of a segment of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft. Receives: Procedure: Cryopreserved aorta |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day mortality
The rate of death at 90 days.
Measured: 90 days
Secondary 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Jan 2019
- Primary completion31 Dec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Trachea DiseasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Shing Chen, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850742
- Sponsor's protocol ID
- 201812035DINC
- Status last verified
- Apr 2021
- First submitted
- 18 Apr 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12735581Martinod 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.
PubMed 15734409Seguin 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.
PubMed 19231406Martinod 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.
PubMed 29800033Martinod 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.
PubMed 28109571
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices
- ClinicalTrials.gov ID
- NCT04850742
- Acronym / sponsor ID
- 201812035DINC
- Conditions
- Trachea Diseases, Tracheal Stenosis, Lung Cancer, Tuberculosis; Tracheitis, Airway Disease
- Keywords
- tracheal reconstruction, bronchial reconstruction, cryopreserved aorta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We used a segment of cryopreserved aorta as a graft for reconstruction for long segment tracheobronchial lesion in human.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryopreserved aorta | Experimental | Procedure: Cryopreserved aortaAfter resection of a segment of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryopreserved aortaAfter 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. | Procedure or surgery | Cryopreserved aorta |
Primary outcome
90-day mortality
Time frame: 90 days
The rate of death at 90 days.
1 secondary outcome
90-day morbidity
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Background: PubMed 12735581Martinod 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.
- Background: PubMed 15734409Martinod 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.
- Background: PubMed 19231406Seguin 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.
- Background: PubMed 29800033Martinod 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.
- Background: PubMed 28109571Martinod 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Shing Chen, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryopreserved aorta in people with Trachea Diseases and Tracheal Stenosis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04850742, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.