UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046239 |
|---|---|
| Receipt number | 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 18:47:12 |
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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
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
naoya@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto Katsura Hospital, Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052765
