NCT04263129

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

2.3 years

First QC Date

November 22, 2019

Last Update Submit

October 17, 2022

Conditions

Tracheal Disease

Keywords

artificial tracheatracheal reconstructionbronchial reconstruction

Outcome Measures

Primary Outcomes (1)

  • Assessment of survival at 3 months

    Rate of death at 3 months

    3 months

Secondary Outcomes (2)

  • Assessment of survival at 12 months

    12 months

  • Assessment of survival at 60 months

    60 months

Interventions

Tracheal, carinal or bronchial transplantation using a stented cryopreserved aorticPROCEDURE

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients treated by human cryopreserved (-80°C) aortic allograft in thoracic surgery dept of Avicenne Hospital, Bobigny, France

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital AVICENNES Service de Chirurgie Thoracique

Bobigny, 93000, France

Location

Related Publications (3)

  • 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.

    PMID: 41390914DERIVED

  • Onorati 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.

    PMID: 37854807DERIVED

  • Martinod 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.

    PMID: 35778956DERIVED

MeSH Terms

Conditions

Tracheal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2019

First Posted

February 10, 2020

Study Start

July 1, 2019

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

October 18, 2022

Record last verified: 2022-10

Locations

FR(1)