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Thulium Contact Laser of Laryngotracheal Stenosis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02587546
Enrollment
31
Registered
2015-10-27
Start date
2015-10-31
Completion date
2018-09-30
Last updated
2019-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral Vocal Cord Paresis, Laryngeal Carcinoma, Subglottic Stenosis

Keywords

laryngeal carcinoma, bilateral vocal cord paralysis, laryngotracheal stenosis, laser treatment, decannulation, voice, swallowing

Brief summary

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

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.

Interventions

PROCEDURElaryngeal carcinoma

treatment of laryngeal carcinoma using thulium contact laser

PROCEDUREbilateral vocal cord paralysis

treatment of bilateral vocal cord paralysis using thulium contact laser

PROCEDUREsubglottic stenosis

treatment of subglottic stenosis using thulium contact laser

Sponsors

University Hospital Ostrava
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of carcinoma recurrence in the patient population36 monthsThe percentage of carcinoma recurrence will be monitored and evaluated within the study subjects.

Secondary

MeasureTime frameDescription
Percentage of decannulation in the patient population36 monthsThe percentage of decannulation will be monitored among the study subjects.
Voice quality (Voice Handicap Index)36 monthsVoice 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) questionnaire36 monthsSwallowing will be assessed in the study group using the SWAL-QOL measurement tool (questionnaire) providing precise evaluation of the condition.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026