Thulium Contact Laser of Laryngotracheal Stenosis

NCT02587546 | Completed

• 1 other identifier: FNO-ENT-thulium
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Carcinoma; Bilateral Vocal Cord Paresis; Subglottic Stenosis

Keywords

laryngeal carcinoma; bilateral vocal cord paralysis; laryngotracheal stenosis; laser treatment; decannulation; voice; swallowing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of decannulation in the patient population

  36 months

• Voice quality (Voice Handicap Index)

  36 months

• Swallowing (SWAL-QOL) questionnaire

  36 months

Study Arms (3)

laryngeal carcinoma

EXPERIMENTAL

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

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

Procedure: bilateral vocal cord paralysis

subglottic stenosis

EXPERIMENTAL

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

Procedure: subglottic stenosis

Interventions

laryngeal carcinoma PROCEDURE

treatment of laryngeal carcinoma using thulium contact laser

laryngeal carcinoma

bilateral vocal cord paralysis PROCEDURE

treatment of bilateral vocal cord paralysis using thulium contact laser

bilateral vocal cord paralysis

subglottic stenosis PROCEDURE

treatment of subglottic stenosis using thulium contact laser

subglottic stenosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• non signing of informed consent

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70800, Czechia

Location

Related Publications (6)

• 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.

  PMID: 25503538 BACKGROUND

• 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.

  PMID: 25837666 BACKGROUND

• 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.

  PMID: 25351502 BACKGROUND

• 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.

  PMID: 26059854 BACKGROUND

• 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.

  PMID: 22040808 BACKGROUND

• 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.

  PMID: 22767984 BACKGROUND

MeSH Terms

Conditions

Laryngeal Neoplasms; Vocal Cord Paralysis

Interventions

GGNBP2 protein, human

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karol Zelenik, MD,PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 27, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

CZ (1)