Clinical trial NCT04850742: Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices
Official title: Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trachea Diseases
Tracheal Stenosis
Lung Cancer
Tuberculosis; Tracheitis
Airway Disease
Keywords: tracheal reconstruction
bronchial reconstruction
cryopreserved aorta
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We used a segment of cryopreserved aorta as a graft for reconstruction for long segment tracheobronchial lesion in human.


Eligibility criteria: Inclusion criteria:

* Patients with advanced benign or malignant lesions involving trachea or bronchi, and has failed conventional treatment.
* Patients with proximal pulmonary tumors that require surgical resection and has involved proximal airways which is indicated for a pneumonectomy, sleeve lobectomy, or carina resection.

Exclusion criteria:

* Less than 20-year-old
* Unable to obtain informed consent.
* Pulmonary tumors that can be treated with standard lobectomy.
* Unresectable locally advanced malignant tumors
* Malignant tumors with contralateral lymph nodes involvement.
* Malignant tumors with distal metastases; except for simple resectable brain metastasis.
* Tracheal lesions which can be treated with standard resection and direct anastomosis.
* Allergic to iodine
* Unable to tolerate standard lobectomy
* Has human immunodeficiency virus infection
* Tracheal stenosis at proximal 2 cm on upper trachea

Primary outcomes:
measure: 90-day mortality
timeFrame: 90 days
Secondary outcomes:
measure: 90-day morbidity
timeFrame: 90 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jin-Shing Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinod E, Seguin A, Pfeuty K, Fornes P, Kambouchner M, Azorin JF, Carpentier AF. Long-term evaluation of the replacement of the trachea with an autologous aortic graft. Ann Thorac Surg. 2003 May;75(5):1572-8; discussion 1578. doi: 10.1016/s0003-4975(03)00120-6.
citation: Martinod E, Seguin A, Holder-Espinasse M, Kambouchner M, Duterque-Coquillaud M, Azorin JF, Carpentier AF. Tracheal regeneration following tracheal replacement with an allogenic aorta. Ann Thorac Surg. 2005 Mar;79(3):942-8; discussion 949. doi: 10.1016/j.athoracsur.2004.08.035.
citation: Seguin A, Radu D, Holder-Espinasse M, Bruneval P, Fialaire-Legendre A, Duterque-Coquillaud M, Carpentier A, Martinod E. Tracheal replacement with cryopreserved, decellularized, or glutaraldehyde-treated aortic allografts. Ann Thorac Surg. 2009 Mar;87(3):861-7. doi: 10.1016/j.athoracsur.2008.11.038.
citation: Martinod E, Chouahnia K, Radu DM, Joudiou P, Uzunhan Y, Bensidhoum M, Santos Portela AM, Guiraudet P, Peretti M, Destable MD, Solis A, Benachi S, Fialaire-Legendre A, Rouard H, Collon T, Piquet J, Leroy S, Venissac N, Santini J, Tresallet C, Dutau H, Sebbane G, Cohen Y, Beloucif S, d'Audiffret AC, Petite H, Valeyre D, Carpentier A, Vicaut E. Feasibility of Bioengineered Tracheal and Bronchial Reconstruction Using Stented Aortic Matrices. JAMA. 2018 Jun 5;319(21):2212-2222. doi: 10.1001/jama.2018.4653.
citation: Martinod E, Paquet J, Dutau H, Radu DM, Bensidhoum M, Abad S, Uzunhan Y, Vicaut E, Petite H. In Vivo Tissue Engineering of Human Airways. Ann Thorac Surg. 2017 May;103(5):1631-1640. doi: 10.1016/j.athoracsur.2016.11.027. Epub 2017 Jan 18.