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The 585-nm Pulsed Dye Laser for Recurrent Respiratory Papillomatosis:  A Randomized Controlled 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.

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Matthew t brigger m d massachusetts eye and ear infirmary harvard medical school

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


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