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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028661
Receipt No. R000030518
Scientific Title Difference of bile duct visualization by timing of indocyanine green injection in fluorescent imaging on laparoscopic cholecystectomy
Date of disclosure of the study information 2017/08/15
Last modified on 2019/08/16

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Basic information
Public title Difference of bile duct visualization by timing of indocyanine green injection in fluorescent imaging on laparoscopic cholecystectomy
Acronym Timing of indocyanine green injection in fluorescent imaging on laparoscopic cholecystectomy
Scientific Title Difference of bile duct visualization by timing of indocyanine green injection in fluorescent imaging on laparoscopic cholecystectomy
Scientific Title:Acronym Timing of indocyanine green injection in fluorescent imaging on laparoscopic cholecystectomy
Region
Japan

Condition
Condition Gall bladder stone, cholecystitis, Gall bladder tumor
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the appropriate timing of indocyanine green injection in fluorescent imaging
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference of fluorescence intensity at common bile duct
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Patients who take injection of 0.25mg/kg indocyanine green the day before operation
Interventions/Control_2 Patients who take injection of 2.5mg indocyanine green just before operation
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 Patients who undergo laparoscopic cholecystectomy or deroofing of liver cyst.
Key exclusion criteria Patients who have Allergy of indocyanine green
Patients who have history of severe iodine allergy
Patients who are inappropriate for this study judged by doctor
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kiyoshi
Middle name
Last name Hasegawa
Organization Tokyo university
Division name Hepato-Biliary-Pancreatic Surgery Division
Zip code 1138655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5800-8841
Email kihase-tky@umin.ac.jp

Public contact
Name of contact person
1st name Masaru
Middle name
Last name Matsumura
Organization Tokyo university
Division name Hepato-Biliary-Pancreatic Surgery Division
Zip code 1138655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5800-8841
Homepage URL
Email MATSUMURAM-SUR@h.u-tokyo.ac.jp

Sponsor
Institute Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, the University of Tokyo
Institute
Department

Funding Source
Organization Tokyo University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel 03-5800-8841
Email ethics@m.u-tokyo.ac.jp

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 08 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 20
Results
One-day before administration relates to the better bile-backgound contrast in ICG fluorescent imaging compared with the operative day administration
Results date posted
2019 Year 05 Month 06 Day
Results Delayed
Delay expected
Results Delay Reason preparation for submission
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
2016 Year 01 Month 05 Day
Date of IRB
2016 Year 01 Month 05 Day
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2017 Year 06 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 14 Day
Last modified on
2019 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030518

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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