Treatment of lymphangiomas with OK-432 (Picibanil) sclerotherapy: A prospective multi-institutional trial
Archives of Otolaryngology - Head and Neck Surgery
Objective: To describe and to determine the robustness of our study evaluating the efficacy of OK-432 (Picibanil) as a therapeutic modality for lymphangiomas. Design and Setting: Prospective, randomized trial and parallel-case series at 13 US tertiary care referral centers. Subjects: Thirty patients diagnosed as having lymphangioma. Ages in 25 ranged from 6 months to 18 years. Twenty-nine had lesions located in the head-and-neck area. Intervention: Every patient received a 4-dose injection series of OK-432 scheduled 6 to 8 weeks apart unless a contraindication existed or a complete response was observed before completion of all injections. A control group was observed for 6 months. Outcome Measures: Successful outcome of therapy was defined as a complete or a substantial (>60%) reduction in lymphangioma size as determined by calculated lesion volumes on computed tomographic or magnetic resonance imaging scans. Results: Overall, 19 (86%) of the 22 patients with predominantly macrocystic lymphangiomas had a successful outcome. Conclusions: OK-432 should be efficacious in the treatment of lymphangiomas. Our study design is well structured to clearly define the role of this treatment agent.
Giguère, C., Bauman, N., Sato, Y., Burke, D., Greinwald, J., Pransky, S., Kelley, P., Georgeson, K., & Smith, R. (2002). Treatment of lymphangiomas with OK-432 (Picibanil) sclerotherapy: A prospective multi-institutional trial. Archives of Otolaryngology - Head and Neck Surgery, 128 (10). http://dx.doi.org/10.1001/archotol.128.10.1137