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The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryopreserved aortic patch | Experimental | Using the cryopreserve aortic patch to repair the tracheobronchial defect. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryopreserved aortic patch | Procedure | After identifying the tracheal or bronchial defect with standard surgical techniques, the airway gap is reconstructed with a patch 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 silicon stent is inserted to prevent collapse for the aortic graft. |
| Measure | Description | Time Frame |
|---|---|---|
| 90-day mortality | The rate of death at 90 days. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao-Wen Lu, MD | Contact | +886972652324 | i2363160@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin-Shing Chen, MD, PhD | National Taiwan University Hospital, Taipei, 100 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Not yet recruiting | Taipei | 100 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38494361 | Background | Hung WT, Liao HC, Hsu HH, Chen JS. Stented cryopreserved aortic allograft for reconstruction of long-segment post-tuberculosis tracheal stenosis. J Formos Med Assoc. 2024 Jul;123(7):818-820. doi: 10.1016/j.jfma.2024.03.006. Epub 2024 Mar 16. | |
| 35778956 | Background | 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. |
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| ID | Term |
|---|---|
| D014133 | Tracheal Diseases |
| D056151 | Airway Remodeling |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
|
| 29800033 | 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. |
| 38170278 | Background | Karkhanis T, Byju AG, Morales DL, Zafar F, Haridas B. Composite Biosynthetic Graft for Repair of Long-Segment Tracheal Stenosis: A Pilot In Vivo and In Vitro Feasibility Study. ASAIO J. 2024 Jun 1;70(6):527-534. doi: 10.1097/MAT.0000000000002130. Epub 2024 Jan 3. |
| 26290833 | Background | Allen MS. Surgery of the Trachea. Korean J Thorac Cardiovasc Surg. 2015 Aug;48(4):231-7. doi: 10.5090/kjtcs.2015.48.4.231. Epub 2015 Aug 5. |
| 29444919 | Background | Etienne H, Fabre D, Gomez Caro A, Kolb F, Mussot S, Mercier O, Mitilian D, Stephan F, Fadel E, Dartevelle P. Tracheal replacement. Eur Respir J. 2018 Feb 14;51(2):1702211. doi: 10.1183/13993003.02211-2017. Print 2018 Feb. |
| 12645751 | Background | Grillo HC. Development of tracheal surgery: a historical review. Part 2: Treatment of tracheal diseases. Ann Thorac Surg. 2003 Mar;75(3):1039-47. doi: 10.1016/s0003-4975(02)04109-7. No abstract available. |
| 12607695 | Background | Grillo HC. Development of tracheal surgery: a historical review. Part 1: Techniques of tracheal surgery. Ann Thorac Surg. 2003 Feb;75(2):610-9. doi: 10.1016/s0003-4975(02)04108-5. No abstract available. |
| 28203439 | Background | Madden BP. Evolutional trends in the management of tracheal and bronchial injuries. J Thorac Dis. 2017 Jan;9(1):E67-E70. doi: 10.21037/jtd.2017.01.43. |
| 24980209 | Background | Prokakis C, Koletsis EN, Dedeilias P, Fligou F, Filos K, Dougenis D. Airway trauma: a review on epidemiology, mechanisms of injury, diagnosis and treatment. J Cardiothorac Surg. 2014 Jun 30;9:117. doi: 10.1186/1749-8090-9-117. |