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

History of Changes

Purpose

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
Recurrent Respiratory Papillomatosis

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	A Multi-Center, Randomized, Controlled Trial of the Pulsed Dye Laser for Juvenile Onset Recurrent Respiratory Papillomatosis

Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:

Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis [ Time Frame: One Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	34
Study Start Date:	January 2007
Study Completion Date:	June 2009

Groups/Cohorts
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.

Groups/Cohorts

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

Ages Eligible for Study:	1 Year to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Children with severe JORRP

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550914

Locations

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

Investigators

Study Chair:

Christopher Hartnick, M.D.

Massachusetts Eye and Ear Infirmary

More Information

No publications provided

Responsible Party:	Christopher Hartnick, M.D., Principal Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:	NCT00550914 History of Changes
Other Study ID Numbers:	07-01-005, 07-01-005
Study First Received:	October 26, 2007
Last Updated:	July 6, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts Eye and Ear Infirmary:

Papilloma, Papillomatosis, Laser, Laser Surgery

Additional relevant MeSH terms:

Papilloma
Respiratory Tract Infections
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

Neoplasms
Infection
Respiratory Tract Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on May 16, 2013

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