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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046239
Receipt No. R000052765
Scientific Title Investigation of the optimal condition for intraoperative cholangiography using indocyanine green
Date of disclosure of the study information 2021/12/01
Last modified on 2021/11/30

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Basic information
Public title Investigation of the optimal condition for intraoperative cholangiography using indocyanine green
Acronym Investigation of the optimal condition for intraoperative cholangiography using indocyanine green
Scientific Title Investigation of the optimal condition for intraoperative cholangiography using indocyanine green
Scientific Title:Acronym Investigation of the optimal condition for intraoperative cholangiography using indocyanine green
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to demonstrate the feasibility of an intraoperative real-time cholangiography using indocyanine green and a near-infrared camera.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Visuality of the intraoperative cholanigography
Key secondary outcomes Visuality of the extrahepatic bile ducts.
Visuality of the intrahepatic bile ducts.
Detactability of bile leak during surgery.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Intrabiliary injection of indocyanine green solution.
Observation of the fluorescence using near-infrared camera.
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 Patients who undergo hepatobiliary surgery.
Objective surgeries are hepatectomy, fenestration of cyst and cholecystectomy.
Key exclusion criteria Patients who has cholestasis, jaundice, allegy to iodine and sensitivity to indocyanine green.
Pregnant woman.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Naoya
Middle name
Last name SASAKI
Organization Kyoto Katsura Hospital
Division name Surgery
Zip code 615-8256
Address 17 Yamadahiraocho, Nishikyoku, Kyoto, Japan
TEL 075-391-5811
Email naoya@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Naoya
Middle name
Last name SASAKI
Organization Kyoto Katsura Hospital
Division name Surgery
Zip code 615-8256
Address 17 Yamadahiraocho, Nishikyoku, Kyoto, Japan
TEL 075-391-5811
Homepage URL
Email naoya@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto Katsura Hospital, Surgery
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 The Kyoto Katsura Hospital Ethics and Clinical Research Review Committee
Address 17 Yamadahiraocho, Nishikyoku, Kyoto, Japan
Tel 075-391-5811
Email chiken@katsura.com

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
2021 Year 12 Month 01 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 Open public recruiting
Date of protocol fixation
2021 Year 07 Month 02 Day
Date of IRB
2021 Year 07 Month 29 Day
Anticipated trial start date
2021 Year 07 Month 30 Day
Last follow-up date
2026 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 30 Day
Last modified on
2021 Year 11 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052765

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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