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

This study has been completed.
Sponsor:
Collaborator:
Rady Children's Hospital, San Diego
Information provided by:
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00550914
First received: October 26, 2007
Last updated: July 6, 2010
Last verified: July 2010

October 26, 2007
July 6, 2010
January 2007
Not Provided
Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis [ Time Frame: One Year ] [ Designated as safety issue: No ]
Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis [ Time Frame: One Year ]
Complete list of historical versions of study NCT00550914 on ClinicalTrials.gov Archive Site
Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score [ Time Frame: One Year ] [ Designated as safety issue: No ]
Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score [ Time Frame: One Year ]
Not Provided
Not Provided
 
Multi-Center, Randomized Trial of the Pulsed Dye Laser for JORRP
A Multi-Center, Randomized, Controlled Trial of the Pulsed Dye Laser for Juvenile Onset Recurrent Respiratory Papillomatosis

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Children with severe JORRP

Recurrent Respiratory Papillomatosis
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
June 2009
Not Provided

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
Both
1 Year to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00550914
07-01-005, 07-01-005
No
Christopher Hartnick, M.D., Principal Investigator, Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
Rady Children's Hospital, San Diego
Study Chair: Christopher Hartnick, M.D. Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP