Airway and/or Pulmonary Vessels Transplantation (TRACHBRONCAR)
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|ClinicalTrials.gov Identifier: NCT01331863|
Recruitment Status : Unknown
Verified August 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : April 8, 2011
Last Update Posted : August 29, 2017
- First study (BRONC-ART) The purpose of this prospective study is to evaluate the 90-day morbidity and mortality rates of bronchial transplantation using cryopreserved aortic allograft in proximal lung cancer surgery. The investigators hypothesize that this stage 1-2 surgical innovation could be safe and effective in order to reduce the 90-day morbidity and mortality rates compared to those observed with pneumonectomy, especially when some factors are present: age > 70 years, right side, neoadjuvant chemoradiotherapy.
- Current study (TRACHEO BRONC-ART) The BRONC-ART study was extended to major (malignant or benign) lesions of the trachea requiring airway transplantation.
For these patients, resection followed by direct end to end anastomosis is not possible or at high risk.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Tracheal Neoplasm Tracheal Stenosis||Procedure: Airway and/or pulmonary Vessels Transplantation||Phase 1 Phase 2|
Surgery remains the best option for curative treatment of early stages Non-Small Cell Lung Cancer (NSCLC). Peripheral tumors are usually resected using lobectomy with a low 90-day morbidity and mortality rate (2%). Central NSCLC often require a pneumonectomy with a high 90-day morbidity and mortality rate (up to 24%), especially when some factors are present: age > 70 years, right side, neoadjuvant chemoradiotherapy. On the other hand, bronchoplastic lobectomies have been proposed in order to avoid pneumonectomy. However, more than fifty years after their first description, bronchoplastic lobectomies remain uncommon (<1% of all pulmonary resection). This could be explained by some technical difficulties showing the potential interest of a bronchial substitute. In a 10-year research phase on a sheep model (n=108), we demonstrated that aortic grafts could be valuable substitutes for tracheobronchial replacement. We observed a progressive transformation of the aortic tissue into airway tissue comprising epithelium and regenerated cartilage. The technique was extended to clinical tracheal replacement by us and others with encouraging results. We proposed to evaluate the feasibility of the use of a stent-supported cryopreserved aortic allograft as a bronchial substitute to prevent pneumonectomy and its associated high mortality rate in NSCLC surgery. Primary outcome will be the 90-day mortality. Secondary outcomes will be the postoperative complications, the 90-day morbidity. This prospective open study will include 20 to 30 patients according to eligibility criteria (see below). The operation will consist of the curative resection of the NSCLC followed by the replacement of a bronchial segment using a cryopreserved allograft in order to re-implant a functional pulmonary lobe. A stent will be placed in the graft to prevent airway collapse.
-Current study (TRACHEO BRONC-ART) The BRONC-ART study was extended to major (malignant or benign) lesions of the trachea requiring airway transplantation. For these patients, resection followed by direct end to end anastomosis is not possible or at high risk.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Replacement of the Airways and/or the Pulmonary Vessels Using a Cryopreserved Arterial Allograft|
|Actual Study Start Date :||May 31, 2011|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated Study Completion Date :||November 30, 2018|
Experimental: single arm surgery
Airway and/or pulmonary Vessels Transplantation
Procedure: Airway and/or pulmonary Vessels Transplantation
Use of a stent-supported aortic allograft to prevent pneumonectomy in lung cancer SURGERY
- 90-day mortality [ Time Frame: 3 months ]
- 90-day morbidity [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331863
|Assistance Publique Hôpitaux de Paris, Hôpital Avicenne, CHU Paris-Seine-Saint-Denis||Recruiting|
|Bobigny, Seine-Saint-Denis, France, 93000|
|Contact: Emmanuel MARTINOD, MD, PhD 33(0)148955231 firstname.lastname@example.org|
|Principal Investigator: Emmanuel MARTINOD, MD, PhD|
|Study Director:||Emmanuel MARTINOD, Pr, PhD||Assistance Publique - Hôpitaux de Paris|