Multi-Center, Randomized Trial of the Pulsed Dye Laser for JORRP

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the 585-nm pulse dye laser can decrease the time interval between surgeries and improve voice outcomes in children with severe RRP.

Official Title
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A Multi-Center, Randomized, Controlled Trial of the Pulsed Dye Laser for Juvenile Onset Recurrent Respiratory Papillomatosis

Conditions
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Recurrent Respiratory Papillomatosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Immunocompetent children ages 1-12 with symptomatic JORRP requiring operative intervention Children who have historically required at least four surgeries in the year preceding enrollment to treat laryngeal JORRP Exclusion Criteria: Children who have required fewer than four procedures to treat laryngeal JORRP in the year prior to enrollment. Children who are currently receiving adjuvant therapies for JORRP including cidofovir, interferon, indole-3-carbinol or Hsp-E7. Caregivers who are non-English speaking as the PVRQOL instrument has been validated only in the English language. Children whose families do not sign an informed consent to enter into the study. Children whose families anticipate discontinuing care at a participating institution during the study period

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control arm<br>The conventional therapy arm will undergo debridement with either a powered microdebrider or cold instrumentation excision as per the preference of the individual surgeon. Debridement will be deemed complete after removal of gross papilloma to the extent that the individual surgeon feels can be safely accomplished. Standard microsurgical principles of the larynx will guide debridement in that no opposing mucosal surfaces of the true vocal folds, laryngeal ventricle or inter-arytenoid space will be simultaneously debrided | |
| Experimental Arm<br>Patients enrolled into the conventional therapy plus PDL treatment arm will undergo debridement of the supraglottis and subglottis via conventional techniques as per the individual surgeons preferences followed by therapy to anterior commissure, true vocal folds, laryngeal ventricle and inter-arytenoid space with the pulsed dye laser. Standard laser settings will be a 450 microsecond pulse width, 5 J per pulse maximum of 1Hz, 1 mm spot fiber, 1-2 mm spot size and fluences of 38-255 J/cm2. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis |  | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score |  | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Papilloma, Papillomatosis, Laser, Laser Surgery