UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022973 |
|---|---|
| Receipt number | R000026483 |
| Scientific Title | Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease. |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2022/09/24 10:47:55 |
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Basic information
Public title
Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Acronym
Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Scientific Title
Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Scientific Title:Acronym
Prospective study on the effectiveness assessment of Indocyanine Green Lymphography and Lymphatic Surgery for lymphedema and lymphatic disease.
Region
| Japan |
Condition
Condition
Lymphedema and lymphatic disease
Classification by specialty
| Surgery in general | Breast surgery | Obstetrics and Gynecology |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using indocyanine green lymphography and lymphoscintigraphy, ultrasonography(including elastgraphy), softmeasure 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
We analyze the assesment pre-operation and every 6 month.
Key secondary outcomes
Patient chart (name, patient ID, clinical history, pre and postoperative course, limb circumference, tissue stiffness/softmeasure); echogram(especially collecting lymphatic vessels and elastgrraphy), CT, MRI, 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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
indocyanine green lymphography
lymph vessel assessment
Interventions/Control_2
lymphoscintigraphy
lymph vessel assessment
Interventions/Control_3
Echography and the assessment of collecting lymphatic vessels
Interventions/Control_4
Elastography and tonometer(softmeasure)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
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 our department 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
20
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Mihara |
Organization
Saiseikai Kawaguchi General Hospital
Division name
Department of Lymphatic and Reconstructive Surgery
Zip code
332-8558
Address
5-11-5, Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
TEL
048-253-1551
mihara-m@saiseikai.gr.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Shimizu |
Organization
Saiseikai Kawaguchi General Hospital
Division name
Financial and legal department
Zip code
332-8558
Address
5-11-5 Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
TEL
0482531551
Homepage URL
zaimuhoumu@saiseikai.gr.jp
Sponsor or person
Institute
Saiseikai Kawaguchi General Hospital. Department of lymphatic and reconstructive surgery.
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
Saiseikai Kawaguchi General Hospital
Address
Nishi-kawaguchi 5-11-5, Kawaguchi-shi, Saitamaken, Japan
Tel
048-253-1551
mihara.plasticsurgery@gmail.com
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
済生会川口総合病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.mominoki-shinryosho.jp/cellulitis/evidence/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.mominoki-shinryosho.jp/cellulitis/evidence/
Number of participants that the trial has enrolled
200
Results
Preparing data
Results date posted
| 2022 | Year | 09 | Month | 24 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Preparing data
Date of the first journal publication of results
Baseline Characteristics
Preparing data
Participant flow
Preparing data
Adverse events
Preparing data
Outcome measures
Preparing data
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 01 | Day |
Last modified on
| 2022 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026483
