Study of bleomycin and OK-432 combined scletotherapy for LMs

Not Applicable

• Conditions: ymphangioma (lymphatic malformation, common or cystic lymphatic malformation), and other lymphatic; lymphangioma, lymphatic malformation,; D18.1

• Registration Number: JPRN-jRCTs031180265
• Lead Sponsor: Fujino Akihiro

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-13
• Study Completion: 2022-09-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 29

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of subjects that the volume of therapeutic target area in the lesion is reduced 30% or more

Secondary Outcome Measures

Name	Time	Method
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.