Tracheal DiseaseTRITONNCT04263129
Tracheobronchial Bioengineering Using Aortic Matrices for Airway Reconstruction
An observational study of Tracheal Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A technic of tracheal, carinal or bronchial transplantation using a stented cryopreserved aortic has been implemented by Pr E. Martinod in his thoracic surgery dept. The purpose of this study is to analyze the records of all the patients who have benefited from this treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Disease
- What is being tested?
- Tracheal, carinal or bronchial transplantation using a stented cryopreserved aortic
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 31 Oct 2021
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients treated by human cryopreserved (-80°C) aortic allograft in thoracic surgery dept of Avicenne Hospital, Bobigny, France
Inclusion Criteria:Eligible patients were treated by human cryopreserved (-80°C) aortic allograft after undergoing a standard preoperative evaluation and cardiopulmonary tests. A multidisciplinary team approve d the treatment based on the following criteria: Patients (1) had proximal lung tumors requiring a surgical resection (pneumonectomy, carinal resection, or sleeve lobectomy) that may or may not have been treated with neoadjuvant chemotherapy and had adequate or compromised preoperative lung function tests; or (2) had significant major malignant or benign lesions of the trachea and bronchi untreated with conventional therapeutic approaches, and (3) have signed an informed consent form for this specific surgical intervention.
Exclusion Criteria:Patients were not treated by human cryopreserved (-80°C) aortic allograft if they :
(1) had a lung tumor requiring a standard lobectomy; (2) had nonresectable major locally invasive tumors; (3) had contralateral lymph node invasion; (4) had metastatic disease with the exception of a unique resectable brain metastasis; (5) had tracheal lesions requiring standard resection with direct anastomosis; (6) had an iodine allergy; or (7) received a preoperative evaluation indicating an inability to undergo a standard lobectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tracheobronchial Bioengineering Using Aortic Matrices
A technic of tracheal, carinal or bronchial transplantation using a stented cryopreserved aortic has been implemented by Pr E. Martinod in his thoracic surgery dept. The purpose of this study is to analyze the records of all the patients who have benefited from this treatment.
Read the detailed description
In the context of end-stage tracheobronchial disease (in particular tracheal or carinal indication) this technic propose a therapeutic alternative, in the context of bronchial replacement it allows to avoid pneumonectomy.
The advantages are to reduce mortality at 90 days, functional consequences and long-term complications.
In this observationnel study, data were collected prospectively in the medical records of all patients who have undergone a trachea or artificial bronchus transplant.
- Conditions
- Tracheal Disease
- Being tested
- Tracheal, carinal or bronchial transplantation using a stented cryopreserved aortic
- Keywords
- artificial trachea, tracheal reconstruction, bronchial reconstruction
- Medical subject headings
- Tracheal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal, carinal or bronchial transplantation using a stented cryopreserved aorticProcedure or surgery
Radical resection of the lesions was performed using standard surgical techniques. After resection, airway reconstruction was performed using a human cryopreserved (-80°C) aortic allograft, which was not matched by the ABO and leukocyte antigen systems. To prevent airway collapse, a custom-made stent was inserted into the allograft. In patients with proximal lung tumors, the lung-sparing intervention of bronchial transplantation was used.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of survival at 3 months
Rate of death at 3 months
Measured: 3 months
Secondary outcomes (2)
Assessment of survival at 12 months
Rate of death at 12 months
Measured: 12 months
Assessment of survival at 60 months
Rate of death at 60 months
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Jul 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tracheal DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263129
- Sponsor's protocol ID
- TRITON
- Acronym
- TRITON
- Status last verified
- Oct 2022
- First submitted
- 22 Nov 2019
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martinod E, Onorati I, Radu DM, Santos Portela AM, Peretti M, Bardet J, Maiolino E, Lo Torto S, Uzunhan Y, Freynet O, Chouahnia K, Duchemann B, Brillet PY, Clero D, Juvin C, Lebreton G, Rouard H, Kabbani J, Maurer C, Gauthier A, Mangiapan G, Dutau H, Marquette CH, Malet J, Deslee G, Galvaing G, Chadeyras JB, Tronc F, Gandher C, Buffet C, Bensidhoum M, Miyara M, Dard N, Besnard V, Planes C, Tresallet C, Fournier C, Venissac N, Huet O, Beloucif S, Vicaut E. Tracheobronchial Replacement Using Cryopreserved Aortic Allografts: Results in 50 Patients (TRITON-01 Registry). Eur J Cardiothorac Surg. 2026 Jan 6;68(1):ezaf445. doi: 10.1093/ejcts/ezaf445.
PubMed 41390914Onorati I, Radu DM, Portela AMS, Peretti M, Guiraudet P, Bardet J, Freynet O, Didier M, Uzunhan Y, Chouahnia K, Duchemann B, Bourinet V, Dutau H, Berthet JP, Marquette CH, Tronc F, Sanchez ML, Tresallet C, Fournier C, Venissac N, Miyara M, Vicaut E, Martinod E. Preliminary results in tracheal replacement using stented aortic matrices for primary extensive tracheal cancer. JTCVS Tech. 2023 Jun 23;21:227-236. doi: 10.1016/j.xjtc.2023.05.021. eCollection 2023 Oct.
PubMed 37854807Martinod E, Radu DM, Onorati I, Portela AMS, Peretti M, Guiraudet P, Destable MD, Uzunhan Y, Freynet O, Chouahnia K, Duchemann B, Kabbani J, Maurer C, Brillet PY, Fath L, Brenet E, Debry C, Buffet C, Leenhardt L, Clero D, Julien N, Venissac N, Tronc F, Dutau H, Marquette CH, Juvin C, Lebreton G, Cohen Y, Zogheib E, Beloucif S, Planes C, Tresallet C, Bensidhoum M, Petite H, Rouard H, Miyara M, Vicaut E. Airway replacement using stented aortic matrices: Long-term follow-up and results of the TRITON-01 study in 35 adult patients. Am J Transplant. 2022 Dec;22(12):2961-2970. doi: 10.1111/ajt.17137. Epub 2022 Jul 14.
PubMed 35778956
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheobronchial Bioengineering Using Aortic Matrices
- ClinicalTrials.gov ID
- NCT04263129
- Acronym / sponsor ID
- TRITON / TRITON
- Conditions
- Tracheal Disease
- Keywords
- artificial trachea, tracheal reconstruction, bronchial reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 10 Feb 2020 (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.
A technic of tracheal, carinal or bronchial transplantation using a stented cryopreserved aortic has been implemented by Pr E. Martinod in his thoracic surgery dept. The purpose of this study is to analyze the records of all the patients who have benefited from this treatment.
Detailed description
In the context of end-stage tracheobronchial disease (in particular tracheal or carinal indication) this technic propose a therapeutic alternative, in the context of bronchial replacement it allows to avoid pneumonectomy.
The advantages are to reduce mortality at 90 days, functional consequences and long-term complications.
In this observationnel study, data were collected prospectively in the medical records of all patients who have undergone a trachea or artificial bronchus transplant.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients treated by human cryopreserved (-80°C) aortic allograft in thoracic surgery dept of Avicenne Hospital, Bobigny, France
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 |
|---|---|---|
| Tracheal, carinal or bronchial transplantation using a stented cryopreserved aorticRadical resection of the lesions was performed using standard surgical techniques. After resection, airway reconstruction was performed using a human cryopreserved (-80°C) aortic allograft, which was not matched by the ABO and leukocyte antigen systems. To prevent airway collapse, a custom-made stent was inserted into the allograft. In patients with proximal lung tumors, the lung-sparing intervention of bronchial transplantation was used. | Procedure or surgery | – |
Primary outcome
Assessment of survival at 3 months
Time frame: 3 months
Rate of death at 3 months
2 secondary outcomes
Assessment of survival at 12 months
Time frame: 12 months
Assessment of survival at 60 months
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Derived from this study: PubMed 41390914Martinod E, Onorati I, Radu DM, Santos Portela AM, Peretti M, Bardet J, Maiolino E, Lo Torto S, Uzunhan Y, Freynet O, Chouahnia K, Duchemann B, Brillet PY, Clero D, Juvin C, Lebreton G, Rouard H, Kabbani J, Maurer C, Gauthier A, Mangiapan G, Dutau H, Marquette CH, Malet J, Deslee G, Galvaing G, Chadeyras JB, Tronc F, Gandher C, Buffet C, Bensidhoum M, Miyara M, Dard N, Besnard V, Planes C, Tresallet C, Fournier C, Venissac N, Huet O, Beloucif S, Vicaut E. Tracheobronchial Replacement Using Cryopreserved Aortic Allografts: Results in 50 Patients (TRITON-01 Registry). Eur J Cardiothorac Surg. 2026 Jan 6;68(1):ezaf445. doi: 10.1093/ejcts/ezaf445.
- Derived from this study: PubMed 37854807Onorati I, Radu DM, Portela AMS, Peretti M, Guiraudet P, Bardet J, Freynet O, Didier M, Uzunhan Y, Chouahnia K, Duchemann B, Bourinet V, Dutau H, Berthet JP, Marquette CH, Tronc F, Sanchez ML, Tresallet C, Fournier C, Venissac N, Miyara M, Vicaut E, Martinod E. Preliminary results in tracheal replacement using stented aortic matrices for primary extensive tracheal cancer. JTCVS Tech. 2023 Jun 23;21:227-236. doi: 10.1016/j.xjtc.2023.05.021. eCollection 2023 Oct.
- Derived from this study: PubMed 35778956Martinod E, Radu DM, Onorati I, Portela AMS, Peretti M, Guiraudet P, Destable MD, Uzunhan Y, Freynet O, Chouahnia K, Duchemann B, Kabbani J, Maurer C, Brillet PY, Fath L, Brenet E, Debry C, Buffet C, Leenhardt L, Clero D, Julien N, Venissac N, Tronc F, Dutau H, Marquette CH, Juvin C, Lebreton G, Cohen Y, Zogheib E, Beloucif S, Planes C, Tresallet C, Bensidhoum M, Petite H, Rouard H, Miyara M, Vicaut E. Airway replacement using stented aortic matrices: Long-term follow-up and results of the TRITON-01 study in 35 adult patients. Am J Transplant. 2022 Dec;22(12):2961-2970. doi: 10.1111/ajt.17137. Epub 2022 Jul 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 18 Oct 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of survival at 3 months (time frame: 3 months). 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 NCT04263129, which also lists 3 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 18 Oct 2022.