Laryngeal CarcinomaNCT02587546
Thulium Contact Laser of Laryngotracheal Stenosis
A study testing laryngeal carcinoma, bilateral vocal cord paralysis and subglottic stenosis in people with Laryngeal Carcinoma and Bilateral Vocal Cord Paresis, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laryngeal Carcinoma, Bilateral Vocal Cord Paresis, Subglottic Stenosis
- What is being tested?
- laryngeal carcinoma, bilateral vocal cord paralysis and subglottic stenosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCzechia
- Study dates
- Oct 2015to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- non signing of informed consent
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70800
About this study
Official title: 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.
Read the 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.
- Being tested
- laryngeal carcinoma, bilateral vocal cord paralysis, subglottic stenosis
- Keywords
- laryngeal carcinoma, bilateral vocal cord paralysis, laryngotracheal stenosis, laser treatment, decannulation, voice, swallowing
- Medical subject headings
- Laryngeal Neoplasms, Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngeal carcinomaProcedure or surgery
treatment of laryngeal carcinoma using thulium contact laser
bilateral vocal cord paralysisProcedure or surgery
treatment of bilateral vocal cord paralysis using thulium contact laser
subglottic stenosisProcedure or surgery
treatment of subglottic stenosis using thulium contact laser
| Study group | Role | What they receive |
|---|---|---|
| laryngeal carcinoma | Experimental | patients with T1-T2 (some T3) laryngeal carcinoma will undergo treatment using thulium contact laser surgery - tumour resection Receives: Procedure: laryngeal carcinoma |
| bilateral vocal cord paralysis | Experimental | patients with bilateral vocal cord paralysis treated with partial arytenoidectomy will be treated using thulium laser surgery and laterofixation Receives: Procedure: bilateral vocal cord paralysis |
| subglottic stenosis | Experimental | patients with subglottic stenosis treated endoscopically (incisions and dilatation) will be treated with thulium laser surgery Receives: Procedure: subglottic stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of carcinoma recurrence in the patient population
The percentage of carcinoma recurrence will be monitored and evaluated within the study subjects.
Measured: 36 months
Secondary outcomes (3)
Percentage of decannulation in the patient population
The percentage of decannulation will be monitored among the study subjects.
Measured: 36 months
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.
Measured: 36 months
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Laryngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karol Zelenik, MD,PhD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587546
- Sponsor's protocol ID
- FNO-ENT-thulium
- Status last verified
- Jul 2019
- First submitted
- 23 Oct 2015
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25503538Greulich 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.
PubMed 25837666Mendelsohn 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.
PubMed 25351502Szakacs 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.
PubMed 26059854Riffat 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.
PubMed 22040808Gallo 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.
PubMed 22767984
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thulium Contact Laser in the Treatment of Tumorous and Non-tumorous Laryngotracheal Stenosis
- ClinicalTrials.gov ID
- NCT02587546
- Acronym / sponsor ID
- FNO-ENT-thulium
- Keywords
- laryngeal carcinoma, bilateral vocal cord paralysis, laryngotracheal stenosis, laser treatment, decannulation, voice, swallowing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| laryngeal carcinoma | Experimental | Procedure: laryngeal carcinomapatients with T1-T2 (some T3) laryngeal carcinoma will undergo treatment using thulium contact laser surgery - tumour resection |
| bilateral vocal cord paralysis | Experimental | Procedure: bilateral vocal cord paralysispatients with bilateral vocal cord paralysis treated with partial arytenoidectomy will be treated using thulium laser surgery and laterofixation |
| subglottic stenosis | Experimental | Procedure: subglottic stenosispatients with subglottic stenosis treated endoscopically (incisions and dilatation) will be treated with thulium laser surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- non signing of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laryngeal carcinomatreatment of laryngeal carcinoma using thulium contact laser | Procedure or surgery | laryngeal carcinoma |
| bilateral vocal cord paralysistreatment of bilateral vocal cord paralysis using thulium contact laser | Procedure or surgery | bilateral vocal cord paralysis |
| subglottic stenosistreatment of subglottic stenosis using thulium contact laser | Procedure or surgery | subglottic stenosis |
Primary outcome
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.
3 secondary outcomes
Percentage of decannulation in the patient population
Time frame: 36 months
Voice quality (Voice Handicap Index)
Time frame: 36 months
Swallowing (SWAL-QOL) questionnaire
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Background: PubMed 25503538Warner 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.
- Background: PubMed 25837666Greulich 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.
- Background: PubMed 25351502Mendelsohn 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.
- Background: PubMed 26059854Szakacs 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.
- Background: PubMed 22040808Riffat 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.
- Background: PubMed 22767984Gallo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karol Zelenik, MD,PhD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laryngeal carcinoma, bilateral vocal cord paralysis and subglottic stenosis in people with Laryngeal Carcinoma and Bilateral Vocal Cord Paresis, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of carcinoma recurrence in the patient population (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02587546, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.