Lymphangioma and other lymphatic diseases with similar lesion
Conditions
Interventions
"
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 dos
s judgment, for reasons such as reducing the inflammation induced by OK-432. [Exit criteria] When subjects and family members reach satisfaction with the level of reduction of the lesion. Whe
Sponsors
National Center for Child Health and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects that the volume of therapeutic target area in the lesion is reduced 30% or more | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactAkihiro Fujino
National Center for Child Health and Development Division of Pediatric Surgery
Outcome results
None listed