Treatment of Cystic Hygroma (Lymphangiomas) in Children- Picibanil(OK432) Sclerotherapy-Multicenter Trial
PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to prior
treatment (no prior treatment vs prior surgical treatment) and geographic area.
Patients who meet all study criteria are put in the "Immediate Treatment Group." Patients
receive an intralesional injection of picibanil (OK432) with the aid of ultrasonography or
transillumination for localization of cysts. Treatment repeats every 6-8 weeks for a total
of up to 4 injections.
After completion of treatment, patients are followed at 6 months, 1 year, and 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
to establish whether OK432 sclerotherapy is an effective form of treatment for lymphatic malformations versus the traditional form of treatment, which is surgical excision.
Richard J Smith
University of Iowa
United States: Federal Government
|Childrens National Medical Center||Washington, District of Columbia|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|Children's Hospital of Denver||Denver, Colorado 80218|
|All Children's Hospital||St. Petersburg, Florida 33701|
|Children's Hospitals and Clinics - Minneapolis||Minneapolis, Minnesota 55404|
|University of Wisconsin Hospital and Clinics||Madison, Wisconsin 53792-0001|
|Vanderbilt University||Nashville, Tennessee 37232-6305|
|Children's Associated Medical Group||San Diego, California 92123|
|SUNY Upstate Medical University||Syracuse, New York 13210|
|Oregon Health Sciences University||Portland, Oregon|
|Texas Pediatric Otolaryngology Center||Houston, Texas 77030|
|Children's Hospital of the Kings Daughter||Norfolk, Virginia 23507|
|Children's Hospital of Wisconsin||Milwaukee, Wisconsin 53201|