Airway and/or Pulmonary Vessels Transplantation (TRACHBRONCAR)
Replacement of the Airways and/or the Pulmonary Vessels Using a Cryopreserved Arterial Allograft
- 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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Seine-Saint-Denis
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Bobigny、Seine-Saint-Denis、法国、93000
- Assistance Publique Hôpitaux de Paris, Hôpital Avicenne, CHU Paris-Seine-Saint-Denis
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patient age ≥18 years and patient capable of giving consent to the carrying out of a medical research procedure
- patient with proximal Lung Cancer (LC) requiring surgical resection (carinal resection, pneumonectomy, bronchoplastic lobectomy) after neoadjuvant chemotherapy or not and with adequate preoperative lung function tests
- or patient with proximal LC requiring a pneumonectomy without adequate preoperative lung function tests
- patients with extended lesions malignant or benign of the trachea without bronchitic lesion and who are in therapeutic impasse.
- or patient older than 70 years with proximal LC requiring a pneumonectomy
- decision made by a multidisciplinary team
- patient information and consent
Exclusion Criteria:
- patient age < 18 years or patient not capable of giving consent to the carrying out of a medical research procedure
- patient with proximal or peripheral LC requiring a simple lobectomy
- patient with unresectable LC because of major local involvement, N3 and/or M1 status(with the exception of a unique resectable brain metastasis)
- patient with tracheal lesion that can be isolated from a simple resection anastomosis tracheal
- iodine allergy
- preoperative evaluation not allowing a simple lobectomy
- patient not affiliated to the French Social Security System
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:single arm surgery
Airway and/or pulmonary Vessels Transplantation
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Use of a stent-supported aortic allograft to prevent pneumonectomy in lung cancer SURGERY
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
90-day mortality
大体时间:3 months
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3 months
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次要结果测量
结果测量 |
大体时间 |
---|---|
90-day morbidity
大体时间:90 days
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90 days
|
合作者和调查者
调查人员
- 研究主任:Emmanuel MARTINOD, Pr, PhD、Assistance Publique - Hôpitaux de Paris
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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