Comparison of BL and KTP Laser for Treatment of Benign Vocal Fold Lesions

NCT04513392 | Unknown

• 1 other identifier: v1.0
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Preliminary investigations suggest that a novel blue light (BL) laser with a wavelength of 445nm is comparable to the commonly utilized KTP laser (532nm) for treatment of laryngeal pathologies. An animal study by the Principal Investigators showed that the blue light laser results in significantly less vocal fold scarring compared to the KTP laser, suggesting that the blue light laser may be a better instrument for treating vocal fold disease. However, there are no clinical studies directly comparing the two lasers on treatment of vocal fold pathology. The goal of the proposed study is to directly compare treatment outcomes of the BL laser and KTP laser for benign vocal fold lesions. All laser treatments will be performed in the office under local anesthesia as per standard of care. Outcome variables of interest will be compared between groups, including Voice Handicap Index-10 (VHI-10) score (measured at baseline, 1 week, 1 month, and 3 months post procedure), laryngeal stroboscopic findings (1 and 3 months post procedure), and intra-operative pain. This study will provide support that the blue light laser is a comparable alternative to the KTP laser and allow the addition of this novel laser to the armamentarium for treating vocal fold diseases.

Conditions

Voice Disorders; RRP

Keywords

KTP; Blue light laser; laryngology; in office procedures

Outcome Measures

Primary Outcomes (1)

• Voice Handicap Index-10 (VHI-10)

  VHI-10 is a validated 10-item questionnaire that quantifies the impact of voice limitations on the individual's overall daily function. It has a Cronbach's alpha of 0.90, indicating high internal consistency. It ranges from a score of 0 to 40. The higher the score, the worse the patient's perception of voice handicap. A score of ≥11 is abnormal. It is a standard of care at the Laryngology outpatient clinic at St. Michael's Hospital for patients to fill out the VHI-10 on paper independently before each clinic visit.

  Change in VHI-10 score at 3 months

Secondary Outcomes (2)

• Laryngeal stroboscopy

  3 months post op compared with baseline

• VAS pain scale

  Immediately following laser treatment and daily for 1 week after the treatment

Study Arms (2)

KTP laser treatment

ACTIVE COMPARATOR

All participants will complete a paper Voice Handicap Index-10 (VHI-10) questionnaire and laryngeal stroboscopy examination at baseline. Local anesthesia will be administered as per standard of care for in-office laryngeal procedures. KTP laser will be utilized to ablate the lesion of interest. Immediately following the procedure, participants will complete a VAS pain scale on paper. Participants will be asked to exercise 3 days of absolute voice rest following the procedure. All patients will have follow-up clinic appointments on POD 7, POD 30, and POD 90 after surgery. At each of the follow-up visit, the patients will fill out a paper VHI-10 questionnaire and undergo stroboscopic examination to assess vocal fold vibratory properties and closure, as well as residual lesions. During the first week post procedure, the participants will continue to complete a daily VAS at home for pain assessment.

Procedure: Laser treatment

BL laser treatment

EXPERIMENTAL

The only difference in study procedures between the experimental arm and the control arm is that the experimental arm will use the BL laser. The post-operative instructions and follow-up schedule are identical.

Procedure: Laser treatment

Interventions

Laser treatment PROCEDURE

A flexible laser fiber will be utilized via a channelled laryngoscope to ablate the benign laryngeal lesions as per standard of care.

BL laser treatment; KTP laser treatment

Eligibility Criteria

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

You may qualify if:

• Provision of signed and dated informed consent form;
• Stated willingness to comply with all study procedures and availability for the duration of the study;
• Male and female, aged ≥ 18 years; and
• Diagnosed with benign vocal fold lesions such as papillomas and polyps and who are candidates for elective in office laser treatment for these lesions.

You may not qualify if:

• \< 18 years old;
• Current smokers;
• Vocal fold lesions such as vocal fold leukoplakia and vocal fold cancer;
• Systemic steroid use; and
• History of systemic illness that can affect wound healing.

Sponsors & Collaborators

• University of Toronto: lead

Related Publications (3)

• Zeitels SM, Akst LM, Burns JA, Hillman RE, Broadhurst MS, Anderson RR. Office-based 532-nm pulsed KTP laser treatment of glottal papillomatosis and dysplasia. Ann Otol Rhinol Laryngol. 2006 Sep;115(9):679-85. doi: 10.1177/000348940611500905.

  PMID: 17044539 RESULT

• Hess MM, Fleischer S, Ernstberger M. New 445 nm blue laser for laryngeal surgery combines photoangiolytic and cutting properties. Eur Arch Otorhinolaryngol. 2018 Jun;275(6):1557-1567. doi: 10.1007/s00405-018-4974-8. Epub 2018 Apr 19.

  PMID: 29675755 RESULT

• Lin RJ, Iakovlev V, Streutker C, Lee D, Al-Ali M, Anderson J. Blue Light Laser Results in Less Vocal Fold Scarring Compared to KTP Laser in Normal Rat Vocal Folds. Laryngoscope. 2021 Apr;131(4):853-858. doi: 10.1002/lary.28892. Epub 2020 Aug 4.

  PMID: 32750168 RESULT

MeSH Terms

Conditions

Voice Disorders

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

R. Jun Lin, MD

CONTACT

416-864-5279; jrlin13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the statistician and the research coordinator, who are not involved in the care of the patients, will know the randomization codes for allocation concealment. To further minimize bias from the open-labeled design, outcome measures will be collected and assessed by a blinded outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Once consented, study participants will be randomized in a 1:1 ratio to one of two arms using a concealed permutated block randomization scheme to one of 2 arms - an experimental arm of BL laser treatment or a control arm of KTP laser treatment. Randomization sequence will be generated using a random number generator with randomly varying block sizes by the study statistician prior to the initiation of the study. Only the statistician and the research coordinator, who are not involved in the care of the patients, will know the randomization codes for allocation concealment. The intervention, i.e. type of laser used for treating the vocal fold lesions, is impossible to blind. Therefore this study is open-labeled. To further minimize bias from the open-labeled design, outcome measures will be collected and assessed by a blinded outcome assessor.

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: August 14, 2020

Record last verified: 2020-08