Tracheobronchial Bioengineering Using Aortic Matrices for Airway Reconstruction (TRITON)

Tracheobronchial Bioengineering Using Aortic Matrices

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.

Study Overview

• Status: Completed
• Conditions: Tracheal Disease
• Intervention / Treatment: Procedure: Tracheal, carinal or bronchial transplantation using a stented cryopreserved aortic

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 Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• France
  • Bobigny, France, 93000
    • Hopital AVICENNES Service de Chirurgie Thoracique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients treated by human cryopreserved (-80°C) aortic allograft in thoracic surgery dept of Avicenne Hospital, Bobigny, France

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of survival at 3 months	Rate of death at 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of survival at 12 months	Rate of death at 12 months	12 months
Assessment of survival at 60 months	Rate of death at 60 months	60 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: tracheal reconstruction; bronchial reconstruction; artificial trachea
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Tracheal Diseases
• Other Study ID Numbers: TRITON

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No