Laser Treatment Of Vascular Lesions On Vocal Cords

NCT ID: NCT00592644

Last Updated: 2011-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2008-10-31

Brief Summary

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.

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.

Conditions

Ectasia

Keywords

ectasia; vascular lesions; vocal cords; voice; pulsed dye laser

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Pulse Dye Laser

Group Type: EXPERIMENTAL

Pulse Dye laser (PDL)

Intervention Type: PROCEDURE

one-time PDL, in 10 subjects

2

Traditional surgeries

Group Type: ACTIVE_COMPARATOR

CO2 laser or other traditional surgeries

Intervention Type: PROCEDURE

once-time CO2 laser or other conventional surgeries, in other 10 subjects

Interventions

Pulse Dye laser (PDL)

one-time PDL, in 10 subjects

Intervention Type: PROCEDURE

CO2 laser or other traditional surgeries

once-time CO2 laser or other conventional surgeries, in other 10 subjects

Intervention Type: PROCEDURE

Other Intervention Names

the laser made by Cynosure Inc, Mass; the laser made by Cynosure Inc. Mass

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Trustees of Boston University

Principal Investigators

Zhi Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Countries

United States

Other Identifiers

R21DC006853

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21-006853-2

Identifier Type: -

Identifier Source: secondary_id

RDC-006853A

Identifier Type: -

Identifier Source: org_study_id