Tracheobronchial Bioengineering Using Aortic Matrices for Airway Reconstruction

Tracheal Disease Clinical Trial

— TRITON  

Official title:

Tracheobronchial Bioengineering Using Aortic Matrices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04263129
• Other study ID #: TRITON
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tracheal Disease
• Tracheal Diseases

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Hopital AVICENNES Service de Chirurgie Thoracique	Bobigny

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of survival at 3 months	Rate of death at 3 months	3 months
Secondary	Assessment of survival at 12 months	Rate of death at 12 months	12 months
Secondary	Assessment of survival at 60 months	Rate of death at 60 months	60 months