AERATE (dilAtion vs laser Endoscopic Resection in subglottic trAcheal sTEnosis) is a multicentre, investigator-initiated, randomised controlled trial, comparing endoscopic dilation to endoscopic laser resection for simple benign SGS (less than 1 cm long without underlying cartilaginous damage) referred for endoscopic treatment (first treatment or recurrence). The study will be conducted in three centres in France and one in Canada with other centres from France and Canada expected to join. The primary outcome is the recurrence rate of stenosis at 2 years. Recurrence is defined as having a new onset of symptoms along with a stenosis of more than 40% (confirmed by bronchoscopy) requiring a new procedure. A sample size of 100 patients is calculated for the primary endpoint assuming a 10% recurrence rate in the laser resection group and 33% in the dilation group with a statistical significance level of 5%, a power of 80%.
This study is approved by local and national ethics committees as required. Results will be published, and trial data will be made available.
NCT04719845.
AERATE(声门下的扩张与激光内窥镜切除术)是一种多中心,调查员发起的,随机对照试验,比较内镜下扩张术与内镜下激光切除术治疗单纯良性SGS(长度小于1cm,无潜在软骨损伤)的疗效(首次治疗或复发)。该研究将在法国的三个中心和加拿大的一个中心进行,预计法国和加拿大的其他中心也将加入。主要结果是狭窄在2年的复发率。复发被定义为具有新的症状发作以及超过40%的狭窄(通过支气管镜检查确认),需要新的程序。假设激光切除组复发率为10%,扩张组中复发率为33%,统计显着性水平为5%,则为主要终点计算100例患者的样本量。80%的权力。
本研究根据需要得到地方和国家伦理委员会的批准。结果将公布,和试验数据将被提供。
NCT04719845。