Clinical study of bleomycin and OK-432 combined local injection sclerotherapy for intractable lymphatic malformations

Fujino Akihiro0 个研究点目标入组 29 人开始时间: 2019年3月13日最近更新: 2023年10月17日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 29

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

The "clinical study of combination local injection sclerotherapy of bleomycin and OK-432 for intractable lymphatic malformations" demonstrated that this therapy is safe and effective in reducing lesion volume in more than half of patients with refractory disease who have difficulty improving with current therapies. There are no studies in the world that have examined the efficacy and safety of bleomycin in refractory cases from an anteroposterior viewpoint, and the results are extremely significant.

研究设计

研究类型: Interventional

入排标准

年龄范围: ot applicable 至 ot applicable（—）
性别: All

入选标准

•Patients requiring treatment in the National Center for Child Health and Development, diagnosed as lymphangioma (lymphatic malformation, common and cystic lymphatic malformation) or other lymphatic disease with similar pathological tissue.
•Among the above-mentioned subject, patients satisfying the following conditions A and B, and having understood and agreed to the research by document, will be included.
•Condition A; satisfying the following condition a or b.
•a; spongy lesions remaining after the OK-432 therapy in the past
•b; spongy lesion untreated with sclerotherapy and expected of no efficacy of OK-432
•Condition B; surgical resection is difficult to apply.

排除标准

•Patients with any of the following diseases will be excluded.
•Severe lung dysfunction, lung fibrosis lesions and significant lung lesions, history of hypersensitivity to bleomycin hydrochloride and similar compounds to the (peplomycin), severe renal dysfunction, severe heart disease, and history of radiation to the chest and the periphery.

研究者

发起方

Fujino Akihiro

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