Thulium Contact Laser of Laryngotracheal Stenosis

July 31, 2019 updated by: University Hospital Ostrava

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70800
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of decannulation in the patient population
Time Frame: 36 months
The percentage of decannulation will be monitored among the study subjects.
36 months
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.
36 months
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Karol Zelenik, MD,PhD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 25, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-ENT-thulium

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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