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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030590
Receipt No. R000027366
Scientific Title Exploratory research for identification of vessels,bile duct,liver segment and nerve with fluorescence imaging system using Methylenblue in hepato-biliary-pancreatic surgery
Date of disclosure of the study information 2017/12/31
Last modified on 2017/12/27

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Basic information
Public title Exploratory research for identification of vessels,bile duct,liver segment and nerve with fluorescence imaging system using Methylenblue in hepato-biliary-pancreatic surgery
Acronym Exploratory research for identification of vessels,bile duct,liver segment and nerve with fluorescence imaging system using Methylenblue in hepato-biliary-pancreatic surgery
Scientific Title Exploratory research for identification of vessels,bile duct,liver segment and nerve with fluorescence imaging system using Methylenblue in hepato-biliary-pancreatic surgery
Scientific Title:Acronym Exploratory research for identification of vessels,bile duct,liver segment and nerve with fluorescence imaging system using Methylenblue in hepato-biliary-pancreatic surgery
Region
Japan

Condition
Condition Hepato-biliary-pancreatic deseases
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the availability of fluorescence imaging system using methylenblue.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of nerve tissues and lesions which are visible with fluorescence imaging system using methylenblue compared to naked eyes.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Administration of methylen blue and demonstration of fluorescence imaging system
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients scheduled to undergo surgery for hepato-biliary-pacreatic disease including malignant or benign deisease.
Key exclusion criteria The patients who have allergy to methylen blue,poor renal function,glucose-6-phosphate dehydrogenase deficiency, NADPH reducing enzyme deficiency and pregnant woman. The emergency case is also excluded.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Kokudo
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-5800-8841
Email KOKUDO-2SU@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuta Kobayashi and Yoshikuni Kawaguchi
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-5800-8841
Homepage URL
Email KOBAYASHIY-SUR@h.u-tokyo.ac.jp

Sponsor
Institute Graduate School of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization IMI Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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 12 Month 31 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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 11 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 12 Month 27 Day
Last modified on
2017 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027366

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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