Tracheobronchial Bioengineering Using Aortic Matrices for Airway Reconstruction

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 19 February 2024

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.

Details
Condition Tracheal disorder
Age 18-100 years
Treatment Tracheal, carinal or bronchial transplantation using a stented cryopreserved aortic
Clinical Study IdentifierNCT04263129
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Eligible patients were treated by human cryopreserved (80C)
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 (80C)
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
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