UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028226 |
|---|---|
| Receipt number | R000032306 |
| Scientific Title | Consideration of severity classification in limb lymphoedema patients based on lymph function |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2020/01/21 13:51:36 |
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Basic information
Public title
Consideration of severity classification in limb lymphoedema patients based on lymph function
Acronym
Consideration of severity classification in limb lymphoedema patients based on lymph function
Scientific Title
Consideration of severity classification in limb lymphoedema patients based on lymph function
Scientific Title:Acronym
Consideration of severity classification in limb lymphoedema patients based on lymph function
Region
| Japan |
Condition
Condition
chronic lymphedema
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Extremity lymphoedema is classified as stages based on physical assessment such as limb circumference measurement, skin tone, frequency of hypothyroiditis, but these evaluation methods do not reflect lymphatic function. In this study, lymphoscintigraphy (SPECT / CT) and fluorescence lymphangiography with ICG are used to evaluate lymphatic function in limb lymphoedema patients, from that viewpoint classification and severity classification of limb lymphedema It aims. Other factors, skin hardness measured by patient factors and hardness measuring instruments, conservative therapy, and surgical therapy will also be studied and will help to prepare therapeutic guidelines for limb lymphedema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity classification of chronic lymphoedema using lymphoscintigraphy and ICG fluorescence lymphangiography
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Lymphoscintigraphy, ICG fluorescence lymphangiography etc.
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
| 1 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients whose age at registration is from 1 to 80 years, patients without gender (2) Patients diagnosed with limb lymphoedema (3) Presence or absence of previous treatment history is not required (4) Patients whose SBP is less than 160 mm Hg and diastolic blood pressure is less than 100 mm Hg (5) Patients who can walk freely (6) Patients for whom consent is documented for participation in this study
Key exclusion criteria
(1) diabetic patients uncontrollable by medication (fasting blood glucose level 130 mg / dL or more)
(2) Patients who are pregnant, may be pregnant, or prefer pregnancy during treatment
(3) Other patients judged inappropriate for judgment by doctor's judgment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Jiro |
| Middle name | |
| Last name | Maegawa |
Organization
Yokohama City University
Division name
School of Medicine, Department of Plastic and Reconstructive Surgery
Zip code
2360004
Address
Fukuura 3-9, Kanazawa-ku, Yokohama City, Kanagawa Prefecture
TEL
045-787-2709
prs_ycu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Yabuki |
Organization
Yokohama City University
Division name
School of Medicine, Department of Plastic and Reconstructive Surgery
Zip code
2360004
Address
Fukuura 3-9, Kanazawa-ku, Yokohama City, Kanagawa Prefecture
TEL
045-787-2709
Homepage URL
yu1rou@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Yokohama City University Hospital
Address
Fukuura 3-9, Kanazawa-ku, Yokohama City, Kanagawa Prefecture
Tel
045-370-7627
rinri@yokohama-cu.ac.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 13 | Day |
Last modified on
| 2020 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032306
