Tracheobronchial Bioengineering Using Aortic Matrices for Airway Reconstruction

Completed

• Conditions: Tracheal Disease

• Registration Number: NCT04263129
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-10
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of survival at 3 months	3 months	Rate of death at 3 months

Secondary Outcome Measures

Name	Time	Method
Assessment of survival at 12 months	12 months	Rate of death at 12 months
Assessment of survival at 60 months	60 months	Rate of death at 60 months

Trial Locations

Locations (1)

Hopital AVICENNES Service de Chirurgie Thoracique; 🇫🇷 Bobigny, France