UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022689 |
|---|---|
| Receipt number | R000026154 |
| Scientific Title | Examination of the lymphedema improvement with the surgical combination therapy for secondary limbs lymphedema |
| Date of disclosure of the study information | 2016/06/30 |
| Last modified on | 2016/06/10 14:35:36 |
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Basic information
Public title
Examination of the lymphedema improvement with the surgical combination therapy for secondary limbs lymphedema
Acronym
Examination of the lymphedema improvement with the surgical combination therapy
Scientific Title
Examination of the lymphedema improvement with the surgical combination therapy for secondary limbs lymphedema
Scientific Title:Acronym
Examination of the lymphedema improvement with the surgical combination therapy
Region
| Japan |
Condition
Condition
Lymphedema
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We determine improvement with the surgical combination therapy for lymphedema
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Limbs circumference, ICG fluorescent lymphography, SF36
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Vasculized lymph node transfer(VLNT)
Interventions/Control_2
Vasculized lymph node transfer, Lymphaticovenuler anastomosis(LVA)
Interventions/Control_3
Lymphaticovenuler anastomosis
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who there is secondary lymphedema, and expect surgical cure.
The person who is available for LVA conducts LVA by ICG lymphangiography. The person with the LVA treatment resistance receives LNT or VLNT+LVA.
Key exclusion criteria
Those whom we considre inappropiate due to physical and/or mental problem
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukiko Kuramoto |
Organization
Cancer Institute Hospital
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
3-8-31 Ariake, Koutou-ku, Tokyo, 135-8550 Japan
TEL
03-3520-0111
yukiko.kuramoto@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Kuramoto |
Organization
Cancer Institute Hospital
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
3-8-31 Ariake, Koutou-ku, Tokyo, 135-8550 Japan
TEL
03-3520-0111
Homepage URL
yukiko.kuramoto@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Cancer Institute Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 30 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 10 | Day |
Last modified on
| 2016 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026154
| 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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