Thulium Contact Laser of Laryngotracheal Stenosis

Laryngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587546
• Other study ID #: FNO-ENT-thulium
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: September 2018

Study information

• Verified date: July 2019
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bilateral Vocal Cord Paresis
• Constriction, Pathologic
• Laryngeal Carcinoma
• Laryngeal Neoplasms
• Paresis
• Subglottic Stenosis
• Vocal Cord Paralysis

Intervention

Procedure:
• laryngeal carcinoma
treatment of laryngeal carcinoma using thulium contact laser
• bilateral vocal cord paralysis
treatment of bilateral vocal cord paralysis using thulium contact laser
• subglottic stenosis
treatment of subglottic stenosis using thulium contact laser

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (6)

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. — View 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. Review. — View 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. — View 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. — View Citation

Szakács L, Sztanó B, Matievics V, Bere Z, Bach A, Castellanos PF, Rovó 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. — View 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;(12):CD002027. doi: 10.1002/14651858.CD002027.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of carcinoma recurrence in the patient population	The percentage of carcinoma recurrence will be monitored and evaluated within the study subjects.	36 months
Secondary	Percentage of decannulation in the patient population	The percentage of decannulation will be monitored among the study subjects.	36 months
Secondary	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.	36 months
Secondary	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.	36 months