Laser Treatment Of Vascular Lesions On Vocal Cords

Laser Atraumatic Treatment Of Ectasias On Vocal Cords

Small vascular malformations (SVM) on the vocal fold is a common problem that can disturb the voice. The pulsed dye laser (PDL) has been successfully used for treatment of blood vessel abnormalities in surface tissue, through its high selectivity for destroying targeted blood vessels while sparing normal tissue. However, there is no study to determine its clinical benefit for treatment of SVMs on vocal fords. In this proposed study, we plan to make such a determination.We will determine whether PDL will produce better and quicker voice improvement than the conventional surgeries, in 20 patients (10 cases of each group) with vocal fold SVM. We expect that this less invasive laser treatment will provide an ideal and excellent option for this disease.

Study Overview

• Status: Completed
• Conditions: Ectasia
• Intervention / Treatment: Procedure: Pulse Dye laser (PDL); Procedure: CO2 laser or other traditional surgeries

Detailed Description

Clinically, small vascular malformations (SVM) on the vocal fold is a common problem that can disturb the voice. Currently, this problem is treated with endoscopic microsurgery with the use of a Carbon dioxide (CO2) laser or other microsurgeries. However, those treatments are unsatisfactory because of their invasive nature. The pulsed dye laser (PDL) has been successfully used for treatment of blood vessel abnormalities in surface tissue, through its high selectivity for destroying targeted blood vessels while sparing normal tissue. Even thought this process has been in use clinically for the past 5 years, there is no study to determine its clinical benefit for treatment of SVMs on vocal fords, by comparing it with routine surgeries. In this proposed study, we plan to make such a determination, by comparing the voice recovery and voice improvement between this laser and those routine surgeries (with CO2 laser or "cold" instrument).

Our specific aim is to determine whether PDL will produce better and quicker voice improvement than the conventional surgeries, in 20 patients (10 cases of each group) with vocal fold SVM. This is the first study to determine clinical benefit of the microvascular targeting (MVT) technique of laser to treat vocal fold SVMs, by a comparison of the voice results between these two groups. We expect that this less invasive laser treatment will provide an ideal and excellent alternative to current surgical approaches for treatment of this disease.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. have SVMs or other small (2.0 mm diameter or less) vasculature-related lesions on vocal fold
2. Hoarseness or other symptoms of alteration in phonation is persistent least for 3 months
3. have (or have a high risk of) recurrent vocal fold hemorrhage, SVM enlargement or persistent fold vibratory abnormality
4. 18 years of age or older
5. Failure to response to voice training or other non-surgical treatments
6. Require CO2 laser ablation or other surgical removal of the lesion
7. Willingness to participate in a 6-month study and adhere to the follow-up schedule
8. A signed informed consent form

Exclusion Criteria:

1. Age less than 18 years, or older than 64
2. Any evidence of mental impairment such that the patient cannot understand the protocol or be in a position to sign the informed consent form
3. Clinical or histological evidence of malignant conversion
4. Lesion to be larger than 2.00 mm diameter or those non-vascular lesions
5. Pregnant women
6. Severity of disease such that airway patency is in immediate danger
7. Patients for whom the voice quality is particularly important: including signers, actors, or other similar professions or person who requires a very high voice quality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Pulse Dye Laser	Procedure: Pulse Dye laser (PDL); one-time PDL, in 10 subjects; Other Names: the laser made by Cynosure Inc, Mass
Active Comparator: 2; Traditional surgeries	Procedure: CO2 laser or other traditional surgeries; once-time CO2 laser or other conventional surgeries, in other 10 subjects; Other Names: the laser made by Cynosure Inc. Mass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recovery of Voice	5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
clearance of lesion	5 months

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Zhi Wang, MD, Boston University

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: December 31, 2007
• First Submitted That Met QC Criteria: December 31, 2007
• First Posted (Estimate): January 14, 2008

Study Record Updates

• Last Update Posted (Estimate): March 31, 2011
• Last Update Submitted That Met QC Criteria: March 29, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: ectasia; voice; pulsed dye laser; vascular lesions; vocal cords
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: RDC-006853A; R21DC006853 (U.S. NIH Grant/Contract); R21-006853-2