Thulium Contact Laser of Laryngotracheal Stenosis

University Hospital Ostrava

Status: Completed

Conditions: Subglottic Stenosis; Laryngeal Carcinoma; Bilateral Vocal Cord Paresis

Treatments: Procedure: bilateral vocal cord paralysis; Procedure: laryngeal carcinoma; Procedure: subglottic stenosis

Study type: Interventional

Funder types: Other

Identifiers

NCT02587546

FNO-ENT-thulium

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• non signing of informed consent

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 3 patient groups

laryngeal carcinoma

Experimental group

Description:

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

Treatment:

Procedure: laryngeal carcinoma

bilateral vocal cord paralysis

Experimental group

Description:

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

Treatment:

Procedure: bilateral vocal cord paralysis

subglottic stenosis

Experimental group

Description:

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

Treatment:

Procedure: subglottic stenosis