UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety of indocyanine green lymphography for evaluation of lymphedema
Title of the study (Brief title)	Indocyanine green lymphography for lymphedema
Region	Japan

Condition
Condition	lymphedema
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Indocyanine green lymphography (ICG)is applied to clinical widely as a liver function test.These days, ICG is performed for evaluation of lymphedema as a preoperative examination.However, the side effects of ICG are not examined. Then, we perform ICG for lyphedema under medical treatment insurance adaptation outside (patient own expense) and evaluated the safety. Specifically, we carry out observation of whethe the general side effects (shock, nausea, blood vessel pain, fever)of ICG occur.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Check whether there are side effects (shock, nausea, blood vessel pain, fever)
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	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	We carry out local injection of ICG at dorsum of foot and the inside of foot joint intra- or subcutaneously. We trace the flow of ICG with an infrared observation camera. We carry out observation of whether side effects (shock, nausea, blood vessel pain, fever)happen.
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	The person by whom lymphedema continued three months or more and written consent was got.
Key exclusion criteria	Those who have the past of hypersensitivity to iodine. Those who are judged that experimental participation is difficul by moral condition. A pregnant woman, a nursing mother. Moreover, those possible of pregnancy. The person to whom the doctor judged participation of the final examination to be unsuitable.
Target sample size	10

Research contact person
Name of lead principal investigator	Kazuhiro Toriyama
Organization	Nagoya City University Hospital
Division name	Plastic and reconstructive surgery
Address	1-Kawasumi, MIzuho-cho, Mizuho-ku, Nagoya, Japan
TEL	052-858-7514
Email	toriyama@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Takahumi Uchibori
Organization	Nagoya City University Hospital
Division name	Plastic and reconstructive surgery
Address	1-Kawasumi, MIzuho-cho, Mizuho-ku, Nagoya, Japan
TEL	052-858-7514
Homepage URL
Email	uchibori83@gmail.com

Sponsor
Institute	Nagoya city university hospital
Institute
Department

Funding Source
Organization	Nagoya City University Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 11 Month 02 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 10 Month 25 Day
Anticipated trial start date	2016 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 02 Day
Last modified on	2018 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028391