A Multicenter Randomized Controlled Trial of the Pulsed Dye Laser for Children with Severe Juvenile Onset

Recurrent Respiratory Papillomatosis

A multicenter randomized clinical trial is being developed to determine whether the promise provided by the initial investigations of the pulsed dye laser can be realized in terms of truly improving quality of life in children affected with RRP.

The 585 nm Pulsed Dye laser is an "angiolytic" laser that allows treatment of JRRP without injury or scar to important structures such as the vocal cords and the anterior commissure. Preliminary studies using the pulse dye laser in children in addition to standard surgical removal of papillomas have shown promising results (Hartnick et al., Arch Otolaryngol Head Neck Surg. 2007 Feb;133(2):127-30.). Therefore a more complete removal with less scarring and a potentially better voice should be possible. Ultimately, we hope to significantly decrease the number of surgeries needed by achieving a more complete removal of papillomas.

We are seeking patients and parents interested in becoming part of this promising study. Eligible children will be aged 12 or under and have severe RRP requiring four or more surgical procedure per year.

Each child will randomly receive either standard surgical excision or standard surgical excision plus the removal of remaining papillomas with the pulsed dye laser. No child will be treated with placebo. The same procedure will be performed for each surgery needed during the course of a year. We will be monitoring each child’s voice with a questionnaire before and after each surgery. We will be looking to see if the pulsed dye laser proves to decrease the number of needed surgeries and provide an improved voice between surgeries.

The study involves four major medical centers and will be based out of the Massachusetts Eye and Ear Infirmary in Boston, MA under the direction of Dr. Christopher Hartnick. Additional sites where children can be seen, enrolled, and treated will be located in Cincinnati, OH; Birmingham AL; and San Diego CA. We will begin enrolling patients for the Boston center immediately; all centers will begin enrollment by July 1 2007.

If you have any questions or are interested in more information regarding enrollment please contact Dr. Hartnick at 617-573-4206 or Christopher_Hartnick@meei.harvard.edu.