Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 主要终点
- Re-stenosis rate over time
研究概览
简要总结
This is a retrospective, observational cohort study carried out in two operative Units of the University Hospital of Modena (Italy): the Diagnostic and Interventional Bronchoscopy Unit (Unit A) and the Otolaryngology Unit (Unit B). The two units have different protocols routinely applied to treat tracheal benign stenosis. In Unit A, endoscopic treatment is performed through mechanical dilatation via rigid bronchoscopy and further stent placing while in Unit B the endoscopic treatment is performed through balloon dilatation via direct laryngoscopy. The primary purpose was to compare the efficacy of the two technique on tracheal stenosis treatment over time. Patients were defined as "cured" if during the 2 years after 12 months since the last intervention they did not present any of the following: respiratory symptoms, need for a re-intervention or stenosis instability.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years,
- •exclusion from resection-anastomosis surgery after multidisciplinary evaluation,
- •Cotton Meyer > grade II,
- •follow-up of at least 3 years after endoscopic surgery,
- •no previous tracheal surgery.
排除标准
- •age > 80,
- •stent intolerance which requires removal in the first year after endoscopic treatment,
- •performance status > 2,
- •end-stage chronic pulmonary disease,
- •life-threatening stenosis that needs urgent endoscopic treatments,
- •any neoplastic stenosis of the airways,
- •dynamic etiology of tracheal benign stenosis (excessive dynamic airway collapse, tracheobronchomalacia).
结局指标
主要结局
Re-stenosis rate over time
时间窗: 36 months
Patients were defined as cured if during the 2 years after 12 months since the last intervention they did not present any of the following: respiratory symptoms, need for a re-intervention or stenosis instability.
次要结局
未报告次要终点
研究者
Alessandro Marchioni
Principal Investigator
University of Modena and Reggio Emilia