Thulium Contact Laser of Laryngotracheal Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-09-30

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.

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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.

Conditions

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Laryngeal Carcinoma Bilateral Vocal Cord Paresis Subglottic Stenosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laryngeal carcinoma

patients with T1-T2 (some T3) laryngeal carcinoma will undergo treatment using thulium contact laser surgery - tumour resection

Group Type EXPERIMENTAL

laryngeal carcinoma

Intervention Type PROCEDURE

treatment of laryngeal carcinoma using thulium contact laser

bilateral vocal cord paralysis

patients with bilateral vocal cord paralysis treated with partial arytenoidectomy will be treated using thulium laser surgery and laterofixation

Group Type EXPERIMENTAL

bilateral vocal cord paralysis

Intervention Type PROCEDURE

treatment of bilateral vocal cord paralysis using thulium contact laser

subglottic stenosis

patients with subglottic stenosis treated endoscopically (incisions and dilatation) will be treated with thulium laser surgery

Group Type EXPERIMENTAL

subglottic stenosis

Intervention Type PROCEDURE

treatment of subglottic stenosis using thulium contact laser

Interventions

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laryngeal carcinoma

treatment of laryngeal carcinoma using thulium contact laser

Intervention Type PROCEDURE

bilateral vocal cord paralysis

treatment of bilateral vocal cord paralysis using thulium contact laser

Intervention Type PROCEDURE

subglottic stenosis

treatment of subglottic stenosis using thulium contact laser

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. patients with T1-T2 (some T3) laryngeal carcinoma
2. patients with bilateral vocal cord paralysis treated with partial arytenoidectomy and laterofixation
3. patients with subglottic stenosis treated endoscopically