跳至主要内容
临床试验/NCT02587546
NCT02587546已完成不适用

Thulium Contact Laser in the Treatment of Tumorous and Non-tumorous Laryngotracheal Stenosis

University Hospital Ostrava2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

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

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

Experimental

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

Experimental

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

Experimental

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)

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验