UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory research for identification of vessels,bile duct,liver segment and nerve with fluorescence imaging system using Methylenblue in hepato-biliary-pancreatic surgery
Title of the study (Brief title)	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	Norihiro Kokudo
Organization	Graduate School of Medicine, University of Tokyo
Division name	Hepato-Biliary-Pancreatic Surgery Division
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	Yuta Kobayashi and Yoshikuni Kawaguchi
Organization	Graduate School of Medicine, University of Tokyo
Division name	Hepato-Biliary-Pancreatic Surgery Division
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 09 Month 26 Day
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

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Publication of results	Unpublished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