Study of bleomycin and OK-432 combined scletotherapy for LMs

JRCT ID: jRCTs031180265

Registered date:13/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lymphangioma (lymphatic malformation, common or cystic lymphatic malformation), and other lymphatic
• Date of first enrollment: 10/08/2016
• Target sample size: 21
• Study type: Interventional
• Intervention(s): "OK-432 and bleomycin slolution" (0.05 kE / mL and 0.5 mg / mL, respectively) will be injected into the lesion with water-soluble contrast agent Maximum dose of bleomycin is 10 mg /dose and 5 mg/kgBW.Cumulative maximum dose in repeated treatment is 10 mg/kgBW

Outcome(s)

• Primary Outcome: The proportion of subjects that the volume of therapeutic target area in the lesion is reduced 30% or more
• Secondary Outcome: Appearance, degree of uplift due to lesions, clinical symptoms such as lymph leakage and bleeding, pain, and frequency of fever / redness,the subjects' impression of their improvement and their degree of satisfaction. Changes in the lung shadows on chest X-ray.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Fujino Akihiro
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Ministry of Health, Labour and Welfare
• Secondary ID(s): UMIN000023437