Thulium Contact Laser in the Treatment of Tumorous and Non-tumorous Laryngotracheal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Percentage of carcinoma recurrence in the patient population
研究概览
简要总结
The purpose of the study is to compare results of the treatment of tumorous and non-tumorous laryngotracheal stenosis using thulium contact laser versus carbon dioxide laser used in the past.
详细描述
Laryngotracheal stenosis is a serious disease significantly worsening the quality of life. Impaired breathing often leads to tracheotomy, deterioration of the voice leads to communication problems with others and swallowing problems are often present, as well The main causes of laryngotracheal stenosis are post intubation and post tracheostomy conditions, inflammatory process (often autoimmune), tumors (mainly squamous cell carcinoma and chondroma) and trauma. Within the last years there is substantial shift in the treatment strategy from open surgery to endoscopic techniques. However, surgical treatment is often difficult due to demanding exposure of tumor and problematic margins control.
In recent years there has been a development of particular techniques of endoscopic resection of tumors and non-malignant laryngeal glottic and subglottic stenosis using a carbon dioxide (CO2) laser with promising improvement of treatment results.
However, CO2 laser has some limitations, particularly in the treatment of tumors spreading into anterior commissure, because CO2 laser beam cannot get "around the corner". Moreover, subglottic area is also difficult to be reached by CO2 laser beam. Therefore, contact laser with adjustable manipulators with possibility to bend tip of manipulator according to the actual need seems to be of some advantage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with T1-T2 (some T3) laryngeal carcinoma
- •patients with bilateral vocal cord paralysis treated with partial arytenoidectomy and laterofixation
- •patients with subglottic stenosis treated endoscopically
排除标准
- •non signing of informed consent
研究组 & 干预措施
laryngeal carcinoma
patients with T1-T2 (some T3) laryngeal carcinoma will undergo treatment using thulium contact laser surgery - tumour resection
干预措施: laryngeal carcinoma (Procedure)
bilateral vocal cord paralysis
patients with bilateral vocal cord paralysis treated with partial arytenoidectomy will be treated using thulium laser surgery and laterofixation
干预措施: bilateral vocal cord paralysis (Procedure)
subglottic stenosis
patients with subglottic stenosis treated endoscopically (incisions and dilatation) will be treated with thulium laser surgery
干预措施: subglottic stenosis (Procedure)
结局指标
主要结局
Percentage of carcinoma recurrence in the patient population
时间窗: 36 months
The percentage of carcinoma recurrence will be monitored and evaluated within the study subjects.
次要结局
- Percentage of decannulation in the patient population(36 months)
- Voice quality (Voice Handicap Index)(36 months)
- Swallowing (SWAL-QOL) questionnaire(36 months)
