Clinical trial NCT04263129: Tracheobronchial Bioengineering Using Aortic Matrices for Airway Reconstruction
Official title: Tracheobronchial Bioengineering Using Aortic Matrices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheal Disease
Keywords: artificial trachea
tracheal reconstruction
bronchial reconstruction
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of survival at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Assessment of survival at 12 months
timeFrame: 12 months
measure: Assessment of survival at 60 months
timeFrame: 60 months
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hopital AVICENNES Service de Chirurgie Thoracique
Study officials:
References:
citation: 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.