Thulium Contact Laser of Laryngotracheal Stenosis
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|ClinicalTrials.gov Identifier: NCT02587546|
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : August 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Laryngeal Carcinoma Bilateral Vocal Cord Paresis Subglottic Stenosis||Procedure: laryngeal carcinoma Procedure: bilateral vocal cord paralysis Procedure: subglottic stenosis||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thulium Contact Laser in the Treatment of Tumorous and Non-tumorous Laryngotracheal Stenosis|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||September 2018|
Experimental: laryngeal carcinoma
patients with T1-T2 (some T3) laryngeal carcinoma will undergo treatment using thulium contact laser surgery - tumour resection
Procedure: laryngeal carcinoma
treatment of laryngeal carcinoma using thulium contact laser
Experimental: bilateral vocal cord paralysis
patients with bilateral vocal cord paralysis treated with partial arytenoidectomy will be treated using thulium laser surgery and laterofixation
Procedure: bilateral vocal cord paralysis
treatment of bilateral vocal cord paralysis using thulium contact laser
Experimental: subglottic stenosis
patients with subglottic stenosis treated endoscopically (incisions and dilatation) will be treated with thulium laser surgery
Procedure: subglottic stenosis
treatment of subglottic stenosis using thulium contact laser
- Percentage of carcinoma recurrence in the patient population [ Time Frame: 36 months ]The percentage of carcinoma recurrence will be monitored and evaluated within the study subjects.
- Percentage of decannulation in the patient population [ Time Frame: 36 months ]The percentage of decannulation will be monitored among the study subjects.
- Voice quality (Voice Handicap Index) [ Time Frame: 36 months ]Voice quality will be assessed according to the Voice Handicap Index, which is an acknowledged measurement tool providing precise evaluation of the condition.
- Swallowing (SWAL-QOL) questionnaire [ Time Frame: 36 months ]Swallowing will be assessed in the study group using the SWAL-QOL measurement tool (questionnaire) providing precise evaluation of the condition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587546
|University Hospital Ostrava|
|Ostrava, Moravian-Silesian Region, Czechia, 70800|
|Principal Investigator:||Karol Zelenik, MD,PhD||University Hospital Ostrava|