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Matthew T. Brigger, M.D. Massachusetts Eye and Ear Infirmary Harvard Medical School

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The 585-nm Pulsed Dye Laser for Recurrent Respiratory Papillomatosis: A Randomized Controlled Trial in Children. Matthew T. Brigger, M.D. Massachusetts Eye and Ear Infirmary Harvard Medical School. Overview: Current Trial.

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The 585-nm Pulsed Dye Laser for Recurrent Respiratory Papillomatosis: A Randomized Controlled Trial in Children

Matthew T. Brigger, M.D.

Massachusetts Eye and Ear Infirmary

Harvard Medical School

overview current trial
Overview: Current Trial
  • A multicenter effort to assess the benefit of using the 585-nm pulsed dye laser (PDL) in children with RRP
  • All children will be treated
    • No children will receive placebo
    • All will receive at least conventional treatment
  • The safety of the PDL has been established
  • Sites: Boston, San Diego, Birmingham, Cincinnati
background
Background
  • Surgical treatment of RRP
    • The Goal: Remove papillomas to the fullest extent as is safely possible
    • Balance the functions of the larynx
      • Airway, swallowing and voice
    • Preserve normal anatomy
  • Primary methods – microlaryngeal dissection, microdebrider, CO2 laser
the problem
The Problem
  • Surgical therapies involve mucosal disruption
    • Scarring potential
  • “Good surgical technique”
    • Do not disrupt opposing mucosal surfaces
the problem1
The Problem
  • “Difficult to treat areas”
    • Anterior commissure, inter-arytenoid space and laryngeal ventricle
  • Often must leave gross papilloma
  • Notoriously poor voice outcomes due to scarring
basic co 2 laser physics
Basic CO2 Laser Physics
  • “Hemostatic Cutting Laser”
    • Wavelength 10,600 nm in a continuous beam
  • Primarily absorbed by water within tissue
  • Water is heated to steam
  • Steam expands and microscopically tears tissue
  • Various ways to alter the degree of tissue damage
    • defocusing, adjusting fluence (energy density)
a different type of laser
A Different Type of Laser
  • Early 1980’s: Simon Parrish and R. Rox Anderson develop the 585 nm pulsed dye laser based on the concept of selective photothermolysis
    • A novel treatment for cutaneous vascular lesion by atraumatically coagulating microvasculature of lesion while preserving the epithelium
    • Destroys the vessels within the lesion
papilloma histology
Papilloma Histology
  • Highly vascular fibrous core covered by nonkeratinizing squamous epithelium
why is the histology important
Why is the Histology Important?
  • The vascular core of papillomas is a prime target for selective photothermolysis
  • Destruction of papilloma vascular supply should result in involution with mucosal preservation
    • Allow a more complete debulking than traditional staged procedures
    • Potentially better vocal outcomes due to mucosal preservation of the vocal folds
initial data
Initial Data
  • 1993 - reports of efficacy in cutaneous papilloma demonstrated
  • 1997 - Bower presented a pilot study demonstrating efficacy in 9 children
  • 1998 & 2001 - McMillan and Shapshay demonstrated efficacy in 10 adults
    • anterior commissure treated in 6 patients
adult data
Adult Data
  • 2001: Franco et al 1st large series in adults
    • 23 adults (41 procedures on 78 true vocal folds over a period of 19 months under general anesthesia
    • 37 cases of bilateral treatment
      • Anterior commisure in 27
    • Demonstrated feasibilty and safety in large population
      • Marked regression of lesions with no anterior glottic webbing
    • No objective data
pediatric data
Pediatric Data
  • 2007 Hartnick et al
  • 23 patients underwent 37 bilateral procedures at the anterior commissure
  • No episodes of vocal scarring or web formation were seen
  • Trend toward increased time between surgical interventions,
    • treatment group was uncontrolled and heterogenous
how it s done
How it’s Done
  • Setup similar to conventional methods
  • General anesthesia with child in microlaryngeal suspension
  • Debulk exophytic lesions as needed
  • Use fiber through a long cannula or suction
  • Fiber is held 1 mm to 2 mm from tissue and laser is fired
where to go from here
Where To Go From Here?
  • Feasibility and safety has been clearly shown
  • Objective outcomes are lacking
    • Does a more complete excision result in less procedures?
    • Are voice outcomes truly better than conventional therapy?
where to go from here1
Where To Go From Here?
  • A randomized controlled trial with clear objective outcomes
    • Severely affected children will be most likely to demonstrate effects
  • Sufficient power will likely require a multicenter effort
current multicenter rct
Current Multicenter RCT
  • Massachusetts Eye and Ear Infirmary, Boston
  • Rady Children’s Hospital, San Diego
  • The Children’s Hospital of Alabama, Birmingham
  • Cincinnati Children’s Hospital Medical Center
objectives
Objectives
  • Primary: Determine if the PDL can decrease the time interval between surgeries in children with RRP
  • Secondary: Determine if the PDL has improved voice outcomes and laryngoscopic severity scores
patient population
Patient Population
  • Inclusion Criteria
    • Immunocompetent children ages 1-12 with symptomatic JORRP who have required four or more surgeries in the past year
  • Exclusion Criteria
    • Children receiving adjuvant therapies during study period
    • Caregivers who are non-English speaking as the PVRQOL instrument has been validated only in the English language.
patient population1
Patient Population
  • Control group: debridement of papillomas with a powered microdebrider or cold instrumentation without the use of any further methods or adjuvant therapies
  • Experimental group: Primary debridement of non critical regions with conventional methods, followed by treatment of the anterior commissure, inter-arytenoid space and laryngeal ventricle with the pulsed dye laser.
outcomes
Outcomes
  • Follow all patients for 1 year
    • Time interval between treatments
    • Laryngoscopic staging and severity scores for children
    • Pediatric Voice Related Quality of Life (PVRQOL) measurements
      • A validated pediatric voice instrument
important points
Important Points
  • ALL children will be treated
    • No placebo arm
  • If randomized to control arm, each child will still receive the benefits of conventional surgical treatment
  • The PDL has an excellent safety profile
conclusion
Conclusion
  • PDL represents a potential advantage by allowing a more complete debridement of papillomas
  • Need more data to determine the role in routine practice to justify cost
contact information
Contact Information
  • Matthew_Brigger@meei.harvard.edu
  • 617-573-4206