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Thulium Contact Laser of Laryngotracheal Stenosis

Primary Purpose

Laryngeal Carcinoma, Bilateral Vocal Cord Paresis, Subglottic Stenosis

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
laryngeal carcinoma
bilateral vocal cord paralysis
subglottic stenosis
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laryngeal Carcinoma focused on measuring laryngeal carcinoma, bilateral vocal cord paralysis, laryngotracheal stenosis, laser treatment, decannulation, voice, swallowing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

laryngeal carcinoma

bilateral vocal cord paralysis

subglottic stenosis

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Percentage of carcinoma recurrence in the patient population
The percentage of carcinoma recurrence will be monitored and evaluated within the study subjects.

Secondary Outcome Measures

Percentage of decannulation in the patient population
The percentage of decannulation will be monitored among the study subjects.
Voice quality (Voice Handicap Index)
Voice 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) questionnaire
Swallowing will be assessed in the study group using the SWAL-QOL measurement tool (questionnaire) providing precise evaluation of the condition.

Full Information

First Posted
October 23, 2015
Last Updated
July 31, 2019
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT02587546
Brief Title
Thulium Contact Laser of Laryngotracheal Stenosis
Official Title
Thulium Contact Laser in the Treatment of Tumorous and Non-tumorous Laryngotracheal Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Carcinoma, Bilateral Vocal Cord Paresis, Subglottic Stenosis
Keywords
laryngeal carcinoma, bilateral vocal cord paralysis, laryngotracheal stenosis, laser treatment, decannulation, voice, swallowing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laryngeal carcinoma
Arm Type
Experimental
Arm Description
patients with T1-T2 (some T3) laryngeal carcinoma will undergo treatment using thulium contact laser surgery - tumour resection
Arm Title
bilateral vocal cord paralysis
Arm Type
Experimental
Arm Description
patients with bilateral vocal cord paralysis treated with partial arytenoidectomy will be treated using thulium laser surgery and laterofixation
Arm Title
subglottic stenosis
Arm Type
Experimental
Arm Description
patients with subglottic stenosis treated endoscopically (incisions and dilatation) will be treated with thulium laser surgery
Intervention Type
Procedure
Intervention Name(s)
laryngeal carcinoma
Intervention Description
treatment of laryngeal carcinoma using thulium contact laser
Intervention Type
Procedure
Intervention Name(s)
bilateral vocal cord paralysis
Intervention Description
treatment of bilateral vocal cord paralysis using thulium contact laser
Intervention Type
Procedure
Intervention Name(s)
subglottic stenosis
Intervention Description
treatment of subglottic stenosis using thulium contact laser
Primary Outcome Measure Information:
Title
Percentage of carcinoma recurrence in the patient population
Description
The percentage of carcinoma recurrence will be monitored and evaluated within the study subjects.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Percentage of decannulation in the patient population
Description
The percentage of decannulation will be monitored among the study subjects.
Time Frame
36 months
Title
Voice quality (Voice Handicap Index)
Description
Voice quality will be assessed according to the Voice Handicap Index, which is an acknowledged measurement tool providing precise evaluation of the condition.
Time Frame
36 months
Title
Swallowing (SWAL-QOL) questionnaire
Description
Swallowing will be assessed in the study group using the SWAL-QOL measurement tool (questionnaire) providing precise evaluation of the condition.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karol Zelenik, MD,PhD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70800
Country
Czechia

12. IPD Sharing Statement

Citations:
PubMed Identifier
25503538
Citation
Warner L, Chudasama J, Kelly CG, Loughran S, McKenzie K, Wight R, Dey P. Radiotherapy versus open surgery versus endolaryngeal surgery (with or without laser) for early laryngeal squamous cell cancer. Cochrane Database Syst Rev. 2014 Dec 12;2014(12):CD002027. doi: 10.1002/14651858.CD002027.pub2.
Results Reference
background
PubMed Identifier
25837666
Citation
Greulich MT, Parker NP, Lee P, Merati AL, Misono S. Voice outcomes following radiation versus laser microsurgery for T1 glottic carcinoma: systematic review and meta-analysis. Otolaryngol Head Neck Surg. 2015 May;152(5):811-9. doi: 10.1177/0194599815577103. Epub 2015 Apr 2.
Results Reference
background
PubMed Identifier
25351502
Citation
Mendelsohn AH, Kiagiadaki D, Lawson G, Remacle M. CO2 laser cordectomy for glottic squamous cell carcinoma involving the anterior commissure: voice and oncologic outcomes. Eur Arch Otorhinolaryngol. 2015 Feb;272(2):413-8. doi: 10.1007/s00405-014-3368-9. Epub 2014 Oct 29.
Results Reference
background
PubMed Identifier
26059854
Citation
Szakacs L, Sztano B, Matievics V, Bere Z, Bach A, Castellanos PF, Rovo L. A comparison between transoral glottis-widening techniques for bilateral vocal fold immobility. Laryngoscope. 2015 Nov;125(11):2522-9. doi: 10.1002/lary.25401. Epub 2015 Jun 8.
Results Reference
background
PubMed Identifier
22040808
Citation
Riffat F, Palme CE, Veivers D. Endoscopic treatment of glottic stenosis: a report on the safety and efficacy of CO2 laser. J Laryngol Otol. 2012 May;126(5):503-5. doi: 10.1017/S002221511100301X. Epub 2011 Nov 1.
Results Reference
background
PubMed Identifier
22767984
Citation
Gallo A, Pagliuca G, Greco A, Martellucci S, Mascelli A, Fusconi M, De Vincentiis M. Laryngotracheal stenosis treated with multiple surgeries: experience, results and prognostic factors in 70 patients. Acta Otorhinolaryngol Ital. 2012 Jun;32(3):182-8.
Results Reference
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Thulium Contact Laser of Laryngotracheal Stenosis

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