Tracheobronchial Bioengineering Using Aortic Matrices for Airway Reconstruction

NCT ID: NCT04263129

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2021-10-31

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Tracheal, carinal or bronchial transplantation using a stented cryopreserved aortic

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

(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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital AVICENNES Service de Chirurgie Thoracique

Bobigny, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 37854807 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35778956 (View on PubMed)

Other Identifiers

TRITON

Identifier Type: -

Identifier Source: org_study_id