Abstract：
Subglottic stenosis (SGS) is a rare condition that results from progressive narrowing of the upper airways. Outcomes and treatment options depend on the benign or complex nature of the stenosis. Treatment options for SGS include surgery and endoscopic techniques. The main endoscopic techniques used are dilation and laser resection. Observational and retrospective studies suggest that endoscopic laser resection may be more effective than dilation. We, therefore, aimed to compare the effectiveness of dilation and laser resection in preventing recurrence of SGS.
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 (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.
摘要：
声门下狭窄（SGS）是一种罕见的疾病，由上呼吸道进行性狭窄引起。结果和治疗选择取决于狭窄的良性或复杂性质。SGS的治疗选择包括手术和内窥镜技术。使用的主要内窥镜技术是扩张和激光切除术。观察性和回顾性研究表明，内窥镜激光切除术可能比扩张术更有效。我们,因此,目的比较扩张术和激光切除术预防SGS复发的效果。
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。
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。
