Clinical Trials Directory

Trials / Completed

CompletedNCT04263129

Tracheobronchial Bioengineering Using Aortic Matrices for Airway Reconstruction

Tracheobronchial Bioengineering Using Aortic Matrices

Status
Completed
Phase
Study type
Observational
Enrollment
35 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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

Interventions

TypeNameDescription
PROCEDURETracheal, 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.

Timeline

Start date
2019-07-01
Primary completion
2021-10-31
Completion
2021-10-31
First posted
2020-02-10
Last updated
2022-10-18

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04263129. Inclusion in this directory is not an endorsement.