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

NCT00550914 | Completed

• 1 other identifier: 07-01-005
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Recurrent Respiratory Papillomatosis

Keywords

Papilloma, Papillomatosis, Laser, Laser Surgery

Outcome Measures

Primary Outcomes (1)

• Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis

  One Year

Secondary Outcomes (1)

• Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score

  One Year

Study Arms (2)

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.

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with severe JORRP

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• Rady Children's Hospital, San Diego: collaborator

Study Sites (2)

Rady Children's Hospital

San Diego, California, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Recurrent respiratory papillomatosis; Papilloma

Condition Hierarchy (Ancestors)

Neoplasms, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Christopher Hartnick, M.D.

  Massachusetts Eye and Ear Infirmary

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 26, 2007
• First Posted: October 30, 2007
• Study Start: January 1, 2007
• Study Completion: June 1, 2009
• Last Updated: July 8, 2010

Record last verified: 2010-07

Locations

US (2)