Dilatation Versus Endoscopic Laser Resection in Simple Benign Tracheal Stenosis : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 108
- 试验地点
- 8
- 主要终点
- Relapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure
研究概览
简要总结
Multicenter randomized controlled trial comparing endoscopic laser resection vs dilatation in benign tracheal stenosis.
详细描述
An observational study suggests the superiority of endoscopic laser resection over dilatation in idiopathic tracheal stenosis but little litterature has been published on the subject. Hence we decided to design a prospective multicenter open label randomized controlled trial to compare the two interventions. Patients refered for endoscopic treatment of a simple benign tracheal stenosis will be randomized to endoscopic laser resection or dilatation. Randomisation will be stratified for center, type of stenosis (idiopathic vs other) and history of previous endoscopic treatment. Patients will be blinded to treatment but not physician. All patients will be treated with proton pump inhibitors.
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
- Single (Participant)
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
- •Benign simple tracheal stenosis (length of stenosis <1cm without underlying cartilage damage) with planned endoscopic treatment (first treatment or recurrence)
排除标准
- •Less than 18 years old
- •Incapacity to give informed consent
- •Underlying inflammatory suspected to be the cause of stenosis (ex : granulomatosis with polyangitis)
研究组 & 干预措施
Endoscopic laser resection
Using CO2, diode or similar wavelenght laser the stenotic tracheal segment will be vaporized allowing a less than 20% residual stenosis. Dilatation will not be performed after laser resection for residual stenosis.
干预措施: Endoscopic laser resection (Procedure)
Dilatation
Using a ballon or rigid bronchoscope the stenotic tracheal segment will be dilated with or without previous radial incision with electrocautery or laser.
干预措施: Dilatation (Procedure)
结局指标
主要结局
Relapse rate at 2 years of symptomatic tracheal stenosis (> 40%) requiring a new procedure
时间窗: Within 2 years
次要结局
- mMRC(2 years)
- VAS(2 years)
- Measurement of stenosis by cephalo-caudal length at endoscopic follow-up at 1 year(Within 2 years)
- VHI-10(2 years)
- Rate and type of complications and adverse effects depending on the procedure(2 years)
- Time to first symptomatic relapse of tracheal stenosis(2 years)
- Rate of surgical resection following symptomatic recurrence(2 years)
- Relapse rate at 1 year of symptomatic tracheal stenosis (> 40%) requiring a new procedure(1 year)
- Clinical COPD questionnaire(2 years)
- SF-12(2 years)
研究者
Marc Fortin
MD
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec