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Thulium Contact Laser of Laryngotracheal Stenosis

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ClinicalTrials.gov Identifier: NCT02587546
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

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.

Condition or disease Intervention/treatment Phase
Laryngeal Carcinoma Bilateral Vocal Cord Paresis Subglottic Stenosis Procedure: laryngeal carcinoma Procedure: bilateral vocal cord paralysis Procedure: subglottic stenosis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thulium Contact Laser in the Treatment of Tumorous and Non-tumorous Laryngotracheal Stenosis
Study Start Date : October 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis
Drug Information available for: Thulium

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587546


Locations
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Czechia
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 70800
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Principal Investigator: Karol Zelenik, MD,PhD University Hospital Ostrava
Publications:

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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT02587546    
Other Study ID Numbers: FNO-ENT-thulium
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Keywords provided by University Hospital Ostrava:
laryngeal carcinoma
bilateral vocal cord paralysis
laryngotracheal stenosis
laser treatment
decannulation
voice
swallowing
Additional relevant MeSH terms:
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Vocal Cord Paralysis
Paresis
Constriction, Pathologic
Pathological Conditions, Anatomical
Neurologic Manifestations
Nervous System Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases
Paralysis