UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019140 |
|---|---|
| Receipt number | R000022130 |
| 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 | 2015/09/28 |
| Last modified on | 2024/04/09 11:45:22 |
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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 (especially subclinical and early-stage) and lymphatic disease
Classification by specialty
| Surgery in general | Vascular surgery | Cardiovascular surgery |
| Plastic surgery | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patient chart (name, patient ID, clinical history, pre and postoperative course, limb circumference, tissue stiffness); echogram, 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.Particularly Assesment of treatment effect about modified Campisi method for subclinical and early-stage lymphedema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient chart (name, patient ID, clinical history, pre and postoperative course, limb circumference, tissue stiffness); echogram, 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. We analyze patient pre-operation and every 6 months after operation.
Key secondary outcomes
Diagnostic imaging for lymph node. And NECST classification for Afferent and Efferent lymph vessels.
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
Indocyanine green (ICG) lymphography and Lymphatic venous anastomosis (Modified Campisi's LVA for subclinical and early-stage lymphedema)
Interventions/Control_2
Indocyanine green (ICG) lymphography and lymph node transfer
Interventions/Control_3
Indocyanine green (ICG) lymphography and liposuction
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 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
100
Research contact person
Name of lead principal investigator
| 1st name | makoto |
| Middle name | |
| Last name | mihara |
Organization
Saiseikai Kawaguchi General Hospital
Division name
Vascular surgery
Zip code
3328558
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
3328558
Address
5-11-5 Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
TEL
048-253-1551
Homepage URL
zaimuhoumu@saiseikai.gr.jp
Sponsor or person
Institute
Saiseikai Kawaguchi General 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
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
saiseikai kawaguti sogo hospital
Address
nishi-kawagucghi
Tel
04288488848
mihara@makoto.fan
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（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 28 | 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
234
Results
none
Results date posted
| 2024 | Year | 04 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
none
Participant flow
none
Adverse events
none
Outcome measures
none
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022130
| Research Plan | |
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| Research case data | |
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