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Completed

NCT Number: NCT02587546

Thulium Contact Laser of Laryngotracheal Stenosis

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laryngeal carcinoma

Procedure

treatment of laryngeal carcinoma using thulium contact laser

bilateral vocal cord paralysis

Procedure

treatment of bilateral vocal cord paralysis using thulium contact laser

subglottic stenosis

Procedure

treatment of subglottic stenosis using thulium contact laser

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of decannulation in the patient population

    Time frame: 36 months

    The percentage of decannulation will be monitored among the study subjects.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 27, 2015
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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