Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch

Обзор

The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.

Вмешательства

• Процедура Cryopreserved aortic patch
  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.

Первичные конечные точки

• 90-day mortality [Срок оценки: 90 days]

Вторичные конечные точки (1)

• 90-day morbidity [Срок оценки: 90 days]

Критерии участия

Критерии включения

• Congenital tracheal deformities: Includes congenital tracheomalacia, congenital tracheobronchial malformations, complete tracheal rings, etc., with severe clinical symptoms and cases where treatment is recommended after evaluation.
• Acquired tracheal stenosis: Includes tracheal narrowing caused by diseases, endotracheal intubation, or postoperative scar tissue, with severe clinical symptoms and cases where treatment is recommended after evaluation.
• Tracheal injury or tissue defect caused by trauma or burns: Cases requiring surgical repair.
• Tracheal tumors: Reconstruction of tracheal tissue following the removal of benign or malignant tumors.

Критерии исключения

• Patients who are unable to provide informed consent.
• Pulmonary tumors that can be treated with standard lobectomy.
• Locally invasive tumors that are unresectable.
• Presence of contralateral lymph node metastasis.
• Presence of distant metastasis, except for solitary, resectable brain metastasis.
• Tracheal lesions amenable to standard resection with direct anastomosis.
• Preoperative evaluation indicates inability to undergo standard lobectomy.
• Patients infected with human immunodeficiency virus (HIV) or with other immunodeficiency disorders.
• Any condition or circumstance deemed by the principal investigator to potentially interfere with the conduct of the trial (e.g., severely impaired cardiopulmonary function, significant liver or kidney dysfunction, poorly controlled diabetes, high-risk groups, or pregnancy).
• Individuals with concerns about the potential risks of the trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 2 центра

• National Taiwan University Hospital — Taipei
• National Taiwan University Hospital — Taipei

Публикации

• 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. PMID 38494361
• 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, Vica PMID 35778956
• 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 Reco PMID 29800033
• 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. PMID 38170278
• 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. PMID 26290833
• 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. PMID 29444919
• 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. PMID 12645751
• 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. PMID 12607695

Идентификаторы

NCT: NCT06935110 · 202407061DINE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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