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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00550914
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : July 8, 2010
Rady Children's Hospital, San Diego
Information provided by:
Massachusetts Eye and Ear Infirmary

Brief Summary:
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.

Condition or disease
Recurrent Respiratory Papillomatosis

Study Type : Observational
Estimated Enrollment : 34 participants
Time Perspective: Prospective
Official Title: A Multi-Center, Randomized, Controlled Trial of the Pulsed Dye Laser for Juvenile Onset Recurrent Respiratory Papillomatosis
Study Start Date : January 2007
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Control arm
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
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.

Primary Outcome Measures :
  1. Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis [ Time Frame: One Year ]

Secondary Outcome Measures :
  1. Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score [ Time Frame: One Year ]

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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with severe JORRP

Inclusion Criteria:

  1. Immunocompetent children ages 1-12 with symptomatic JORRP requiring operative intervention
  2. Children who have historically required at least four surgeries in the year preceding enrollment to treat laryngeal JORRP

Exclusion Criteria:

  1. Children who have required fewer than four procedures to treat laryngeal JORRP in the year prior to enrollment.
  2. Children who are currently receiving adjuvant therapies for JORRP including cidofovir, interferon, indole-3-carbinol or Hsp-E7.
  3. Caregivers who are non-English speaking as the PVRQOL instrument has been validated only in the English language.
  4. Children whose families do not sign an informed consent to enter into the study.
  5. Children whose families anticipate discontinuing care at a participating institution during the study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00550914

United States, California
Rady Children's Hospital
San Diego, California, United States
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Rady Children's Hospital, San Diego
Study Chair: Christopher Hartnick, M.D. Massachusetts Eye and Ear Infirmary

Responsible Party: Christopher Hartnick, M.D., Principal Investigator, Massachusetts Eye and Ear Infirmary Identifier: NCT00550914     History of Changes
Other Study ID Numbers: 07-01-005
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: July 8, 2010
Last Verified: July 2010

Keywords provided by Massachusetts Eye and Ear Infirmary:
Papilloma, Papillomatosis, Laser, Laser Surgery

Additional relevant MeSH terms:
Respiratory Tract Infections
Respiratory Tract Diseases
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Virus Diseases
Tumor Virus Infections