Clinical trial · Interventional
Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices
NCT04850742CI-TRIAL-00051720unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We used a segment of cryopreserved aorta as a graft for reconstruction for long segment tracheobronchial lesion in human.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Airway Disease | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Trachea Diseases | — | UNRESOLVED | — |
| Tracheal Stenosis | — | UNRESOLVED | — |
| Tuberculosis; Tracheitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryopreserved aorta | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cryopreserved aorta
- description
- After resection of a segment of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft.
- interventionNames
- Procedure: Cryopreserved aorta
Primary outcomes (1)
- measure
- 90-day mortality
- timeFrame
- 90 days
- description
- The rate of death at 90 days.
Secondary outcomes (1)
- measure
- 90-day morbidity
- timeFrame
- 90 days
- description
- The occurrence of complication including 1) anastomotic leakage, 2) pneumonia, 3) difficult weaning, 4) airway obstruction by granulation tissue, 5) stenosis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDMartinod 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
- BACKGROUNDMartinod 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
- BACKGROUNDSeguin 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
- BACKGROUNDMartinod 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
- BACKGROUNDMartinod 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