Thulium Contact Laser of Laryngotracheal Stenosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Laryngeal Carcinoma, Bilateral Vocal Cord Paresis, Subglottic Stenosis

Intervention / Treatment
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* Procedure: laryngeal carcinoma
* Procedure: bilateral vocal cord paralysis
* Procedure: subglottic stenosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: non signing of informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laryngeal carcinoma<br>patients with T1-T2 (some T3) laryngeal carcinoma will undergo treatment using thulium contact laser surgery - tumour resection | Procedure: laryngeal carcinoma<br>* treatment of laryngeal carcinoma using thulium contact laser<br>|
| Experimental: bilateral vocal cord paralysis<br>patients with bilateral vocal cord paralysis treated with partial arytenoidectomy will be treated using thulium laser surgery and laterofixation | Procedure: bilateral vocal cord paralysis<br>* treatment of bilateral vocal cord paralysis using thulium contact laser<br>|
| Experimental: subglottic stenosis<br>patients with subglottic stenosis treated endoscopically (incisions and dilatation) will be treated with thulium laser surgery | Procedure: subglottic stenosis<br>* treatment of subglottic stenosis using thulium contact laser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of carcinoma recurrence in the patient population | The percentage of carcinoma recurrence will be monitored and evaluated within the study subjects. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of decannulation in the patient population | The percentage of decannulation will be monitored among the study subjects. | 36 months | 
| Voice quality (Voice Handicap Index) | Voice quality will be assessed according to the Voice Handicap Index, which is an acknowledged measurement tool providing precise evaluation of the condition. | 36 months | 
| Swallowing (SWAL-QOL) questionnaire | Swallowing will be assessed in the study group using the SWAL-QOL measurement tool (questionnaire) providing precise evaluation of the condition. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngeal carcinoma, bilateral vocal cord paralysis, laryngotracheal stenosis, laser treatment, decannulation, voice, swallowing