UMIN-CTR Clinical Trial

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 Plastic surgery Adult Child
Classification by malignancy	Others
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. Moreover, we focus on the patency rate of lymphatic venous anastomosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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 observationsMoreover, we focus on the patency rate of lymphatic venous anastomosis.
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
Interventions/Control_1	Indocyanine green (ICG) lymphography and ultrasound for the patency rate of Lymphatic venous anastomosis(LVA)
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 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	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Mihaara
Organization	Saiseikai Kawaguchi General Hospital
Division name	Lymphatic and Reconstructive Surgery
Zip code
Address	5-11-5, Nishikawaguchi, Kawaguchi-shi, Saitama, Japan
TEL	0482531551
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
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

Other administrative information
Date of disclosure of the study information	2017 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	2017 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date	2017 Year 07 Month 01 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	2017 Year 06 Month 14 Day
Last modified on	2018 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031793

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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