Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices

NCT04850742 | Unknown DMC

• 1 other identifier: 201812035DINC
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Trachea Diseases; Tracheal Stenosis; Lung Cancer; Tuberculosis; Tracheitis; Airway Disease

Keywords

tracheal reconstruction; bronchial reconstruction; cryopreserved aorta

Outcome Measures

Primary Outcomes (1)

• 90-day mortality

  The rate of death at 90 days.

  90 days

Secondary Outcomes (1)

• 90-day morbidity

  90 days

Study Arms (1)

Cryopreserved aorta

EXPERIMENTAL

After resection of a segment of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft.

Procedure: Cryopreserved aorta

Interventions

Cryopreserved aorta PROCEDURE

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.

Cryopreserved aorta

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 12735581 BACKGROUND

• 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.

  PMID: 15734409 BACKGROUND

• 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.

  PMID: 19231406 BACKGROUND

• 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.

  PMID: 29800033 BACKGROUND

• 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.

  PMID: 28109571 BACKGROUND

MeSH Terms

Conditions

Tracheal Diseases; Tracheal Stenosis; Lung Neoplasms; Tuberculosis; Tracheitis

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections

Study Officials

• Jin-Shing Chen, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 20, 2021
• Study Start: January 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: May 11, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)