UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017855 |
|---|---|
| Receipt number | R000019921 |
| Scientific Title | Prospective study on the effectiveness assessment of Indocyanine Green Lymphography, MR lymphography and Lymphatic Surgery for lymphedema and lymphatic disease. |
| Date of disclosure of the study information | 2015/06/10 |
| Last modified on | 2023/06/16 13:12:09 |
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Basic information
Public title
Prospective study on the effectiveness assessment of Indocyanine Green Lymphography, MR lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Acronym
Prospective study of Lymphatic surgery (Joint research of 2 hospitals).
Scientific Title
Prospective study on the effectiveness assessment of Indocyanine Green Lymphography, MR lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Scientific Title:Acronym
Prospective study of Lymphatic surgery (Joint research of 2 hospitals).
Region
| Japan |
Condition
Condition
Lymphedema and lymphatic disease
Classification by specialty
| Surgery in general | Vascular surgery | Breast surgery |
| Obstetrics and Gynecology | Plastic surgery | Laboratory medicine |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using indocyanine green lymphography and MR lymphography to investigate the pathology and the effectiveness of surgical remedies in lymphedema patients by analyzing pre-, intra-, and post-operative lymphatic assessments, comparing pre and postoperative changes, and assessing the associated clinical symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Patient chart (name, patient ID, clinical history, pre and postoperative course, limb circumference, tissue stiffness); echogram, CT, MRI, MR lymphography, lymphoscintigraphy, indocyanine green lymphography, and lymphoangiography obervations; blood test (complete blood count, chemistry, coagulation, blood type); histopathological analysis (collecting lymphatic vessel, adipose tissue, skin tissue, etc.); clinical photography (bilateral upper limbs for upper limb edema, bilateral lower limbs, abdominal, and inguinal area for lower limb lymphedema); health-related QOL analysis using Short Form (SF)-36 Health Survey; patient weight; general physical and image observations.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Indocyanine green (ICG) lymphography, MR lymphography and Lymphatic surgery
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
All Subjects included in this study are lymphedema and lymphatic disease patients undergoing surgical treatment at 2 hospitals (Tokyo Takanawa Hospital and Nadogaya Hospital) who have been fully informed of all clinical tests, questionnaires, surgical treatments, and the purpose and analysis of this study and have all consented in writing. No age restriction and exclusion criteria were set.
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Mihara |
Organization
Lymphedema clinic of Tokyo Takanawa Hospital, Lymphedema clinic of Nadogaya Hospital.
Division name
Plastic surgery
Zip code
Address
3-10-11, Takanawa, Minato-ku, Tokyo, Japan. 687-4 Natogaya, Kashiwa-shi, Chiba-ken, Japan
TEL
03-3443-9191
mihara.plasticsurgery@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | shusei |
Organization
Tokyo Takanawa Hospital
Division name
somu
Zip code
Address
3-10-11, Takanawa, Minato-ku, Tokyo, Japan
TEL
03-3443-9191
Homepage URL
http://takanawa.jcho.go.jp/medical-treatment-for-foreigners/
mihara-m@saiseikai.gr.jp
Sponsor or person
Institute
Tokyo Takanawa Hospital, Nadogaya Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
東京高輪病院（東京都）、名戸ヶ谷病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 10 | 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 | 05 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 10 | Day |
Last modified on
| 2023 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019921
