UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011130 |
|---|---|
| Receipt number | R000013039 |
| Scientific Title | Pilot study of absolute ethanol injection sclerotherapy for lymphangioma circumscriptum |
| Date of disclosure of the study information | 2013/07/08 |
| Last modified on | 2019/07/30 10:40:07 |
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Basic information
Public title
Pilot study of absolute ethanol injection sclerotherapy for lymphangioma circumscriptum
Acronym
Absolute ethanol sclerotherapy for lymphangioma circumscriptum
Scientific Title
Pilot study of absolute ethanol injection sclerotherapy for lymphangioma circumscriptum
Scientific Title:Acronym
Absolute ethanol sclerotherapy for lymphangioma circumscriptum
Region
| Japan |
Condition
Condition
lymphangioma circumscriptum
Classification by specialty
| Surgery in general | Vascular surgery | Pediatrics |
| Dermatology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the safety and the efficacy of the absolute ethanol injection sclerotherapy for lymphangioma circumscriptum
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
improvement of the lesion
Key secondary outcomes
improvement of the symptom
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Absolute ethanol injections at a time into the lesion
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Any lymphangioma circumscriptum patients requiring treatment who had given us an informed consent to participate in this clinical study
Key exclusion criteria
Not hypersensitive to alcohol
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Fujino |
Organization
National Center for Child Health and Development
Division name
Department of Pediatric Surgery
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku Tokyo, Japan
TEL
03-5494-7144
fujino-a@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Fujino |
Organization
National Center for Child Health and Development
Division name
Department of Pediatric Surgery
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku Tokyo, Japan
TEL
03-5494-7144
Homepage URL
fujino-a@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Keio University School of Medicine
Name of secondary funder(s)
Japan Agency for Medical Research and Development
IRB Contact (For public release)
Organization
Certified Review Board of National Center for Child Health and Development
Address
2-10-1 Okura, Setagaya-Ku, Tokyo Tokyo
Tel
03-3416-0181
rinken@ncchd.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
慶應義塾大学病院（東京都）、国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
9
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Some patients still take the procedure and the observation term is extended.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 27 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 27 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 05 | Day |
Last modified on
| 2019 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013039
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
