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

Phase 3

• Conditions: ymphangioma and other lymphatic diseases with similar lesion

• Registration Number: JPRN-UMIN000023437
• Lead Sponsor: ational Center for Child Health and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-05
• Study Completion: 2023-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

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.