Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence After Therapeutic Bronchoscopy in Lung Cancers (SPOC Study)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 14
- 主要终点
- Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone)
研究概览
简要总结
A tumoral obstruction of the main stem bronchus is frequently observed in the follow-up of lung cancers with a high impact on survival and quality of life of these patients. The endoluminal resection of these tumors through interventional bronchoscopy can remove the tumor but fails to prevent the recurrence. A stent insertion could achieve this goal but this option was never proved in a prospective protocol.
The aim of this study is to analyze the impact of stent insertion on the survival without symptoms of bronchial obstruction in patients treated for their cancer with and without a first line treatment (chemo-radiotherapy or chemotherapy). The patients will be included after resection of the endoluminal symptomatic tumoral obstruction. We will test the effect of the silicone stent insertion ( from NovatechR ) by comparing a stent arm (170 patients with stent insertion) with a control arm (170 patients without stent). The inclusion period will last 3 years with one year of follow-up for each patient. The one-year survival without symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone) will be the main endpoint. All patients without symptomatic recurrence at one year will be controlled endoscopically. Survival and stent tolerance will be studied as secondary endpoints. All endoscopic events will be depicted on photographs or videos. Each endoscopical situation (before and after resection, recurrence or side effects of stents) will be analyzed and registered by an independent committee of 3 international experts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years
- •non-small cell lung cancer,
- •inoperable and location : tracheal, carinal, main bronchus right or left, or intermediate trunk.
- •TNM stage known and oncological treatment later determined
- •central initial intrinsic bronchial obstruction > 50%.
- •resection of tumor with endoscopy, to obtain after therapeutic bronchoscopy a diameter > 50% normal diameter of bronchial segment achieved.
- •Tumoral segment fully recoverable by a stent
- •Written consent, free and informed
- •Patient affiliated or who is entitled to to a social security scheme.
排除标准
- •against-indication for general anesthesia.
- •Patient with one lung not working beyond the stenosis
- •Patient under guardianship
- •Pregnancy
- •12 months follow-up impossible
结局指标
主要结局
Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone)
时间窗: 12 months
次要结局
- For patients who had no symptomatic recurrence of bronchial obstruction Presence of a bronchial stenosis> 50% on a systematic bronchial endoscopy months.(12 months)
- Complications of symptomatic trachea-bronchial prosthesis (mobility or migration, granuloma, congestion) motivating endoscopy.(12 months)
- Quality of life : EORTC(12 months)
- death(12 months)