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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022973
Receipt No. 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 2016/12/31

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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 Obsterics 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
Middle name
Last name Makoto Mihara
Organization Saiseikai Kawaguchi General Hospital
Division name Department of Lymphatic and Reconstructive 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 0482531551
Homepage URL
Email zaimuhoumu@saiseikai.gr.jp

Sponsor
Institute Saiseikai Kawaguchi General Hospital. Department of lymphatic and reconstructive surgery.
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
2016 Year 07 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 No longer recruiting
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
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
2016 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026483

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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