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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014748
Receipt No. R000017142
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 2014/08/06
Last modified on 2016/01/10

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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 Vascular surgery Breast surgery
Plastic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Using indocyanine green 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 We analyze the assesment pre-operation and every 6 month. 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.
Key secondary outcomes

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 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Indocyanine green (ICG) lymphography and Lymphatic venous anastomosis(LVA)
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 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Mihaara
Organization Saiseikai Kawaguchi General Hospital
Division name Department of Vascular Surgery
Zip code
Address 5-11-5, Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
TEL 048-253-1551
Email mihara-m@saiseikai.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Shimizu
Organization Saiseikai Kawaguchi General Hospital
Division name Financial and legal department
Zip code
Address 5-11-5 Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
TEL 048-253-1551
Homepage URL
Email zaimuhoumu@saiseikai.gr.jp

Sponsor
Institute Saiseikai Kawaguchi General Hospital
Institute
Department

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
Email

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
2014 Year 08 Month 06 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Total Number of Lymphatic Venous Anastomosis (LVA);  231 cases

Male    14  (6.06%)
Female 217 (94.94%)

General Anesthesia   1  (0.43%)
Local Anesthesia   230 (99.57%)
 
Upper LVA   8  (3.46%)
Lower LVA 223 (96.54%)
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 No longer recruiting
Date of protocol fixation
2014 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 06 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
2014 Year 08 Month 02 Day
Last modified on
2016 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017142

Research Plan
Registered date File name
2014/08/06 umin140806.5 資料5:本研究の撤回書.pdf

Research case data specifications
Registered date File name
2014/08/06 図00.jpg

Research case data
Registered date File name
2016/01/10 済生会160110.2 LVA security code multi 前向き検討試験 case list 2015.8.6-2015.8.5.xlsx


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