Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices

Lung Cancer Clinical Trial

Official title:

Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04850742
• Other study ID #: 201812035DINC
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 2024

Study information

• Verified date: April 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5
• Est. completion date: March 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Disease
• Lung Cancer
• Tracheal Stenosis
• Tracheitis
• Tuberculosis

Intervention

Procedure:
• Cryopreserved aorta
After resection of the tracheal or bronchial lesion with standard surgical techniques, the airway gap is reconstructed with a segment of human cryopreserved (-80 celsius degree) aortic allograft, which was not matched by the ABO and leukocyte antigen systems. The anastomosis is performed with standard technique for airway anastomosis. An Ultraflex covered tracheobronchial stent is inserted to prevent collapse for the aortic graft.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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, Vénissac 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day mortality	The rate of death at 90 days.	90 days
Secondary	90-day morbidity	The occurrence of complication including 1) anastomotic leakage, 2) pneumonia, 3) difficult weaning, 4) airway obstruction by granulation tissue, 5) stenosis.	90 days