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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000021898
Receipt No. R000025255
Scientific Title Indocyanine green (ICG) application to intraoperative navigation of fluorescence imaging
Date of disclosure of the study information 2016/04/15
Last modified on 2016/04/13

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Basic information
Public title Indocyanine green (ICG) application to intraoperative navigation of fluorescence imaging
Acronym Intraoperative navigation with fluorescence imaging of indocyanine green (ICG)
Scientific Title Indocyanine green (ICG) application to intraoperative navigation of fluorescence imaging
Scientific Title:Acronym Intraoperative navigation with fluorescence imaging of indocyanine green (ICG)
Region
Japan

Condition
Condition Gastrointestinal malignant tumor
Ischemic bowel disease
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of ICG fluorescence imaging for intraoperative identifyning the tumor localization.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Adverse event
Key secondary outcomes Intraoperative visualization rate of lesion.
Histopathological positive rate
Pathological curative resection rate
operative time, bleeding, intra and postoperative complication, recurrence rate
Resected rate

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 Indocyanine green (ICG)
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 A patient who scheduled for treatment with surgery by gstroenterological malignant tumor.

A patient who need surgery due to acute intestinal ischemic bowel disease.
Key exclusion criteria A patient who has a history of allergic reaction to the ICG.

A patient who can not obtain the consent by document.
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masafumi Inomata
Organization Oita University
Division name Gastrointestinal and pediatric surgery
Zip code
Address 1-1Idaigaoka Hasamamachi Yufu city, Oita, Japan
TEL 097-586-5843
Email geka1@oita-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yukio Iwashita
Organization Oita University
Division name Gastrointestinal and pediatric surgery
Zip code
Address 1-1Idaigaoka Hasamamachi Yufu city, Oita, Japan
TEL 097-586-5843
Homepage URL http://www.med.oita-u.ac.jp/surgery1/about/stuff/
Email geka1@oita-u.ac.jp

Sponsor
Institute Oita University
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 大分大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 15 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
Date of protocol fixation
2016 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 15 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
2016 Year 04 Month 13 Day
Last modified on
2016 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025255

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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