UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027972 |
|---|---|
| Receipt number | R000032042 |
| Scientific Title | Assessment of Indocyanine Green excretion using pinpoint endoscopic fluorescence imaging system for diagnosis of biliary atresia; prospective study. |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2018/03/27 10:13:06 |
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Basic information
Public title
Assessment of Indocyanine Green excretion using pinpoint endoscopic fluorescence imaging system for diagnosis of biliary atresia; prospective study.
Acronym
Diagnosis of biliary atresia: assessment of Indocyanine Green excretion.
Scientific Title
Assessment of Indocyanine Green excretion using pinpoint endoscopic fluorescence imaging system for diagnosis of biliary atresia; prospective study.
Scientific Title:Acronym
Diagnosis of biliary atresia: assessment of Indocyanine Green excretion.
Region
| Japan |
Condition
Condition
Biliary atresia
Classification by specialty
| Hepato-biliary-pancreatic surgery | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To inject "Indocyanine Green" to the children with possible diagnosis of biliary atresia. Pinpoint endoscopic fluorescence imaging system can be used to assess if the "Indocyanine Green" is excreted.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
After injection of "Indocyanine Green", all feces (within 12 hours post-injection) are exposed by Pinpoint endoscopic fluorescence imaging system, to see if "Indocyanine Green" is contained or not.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To inject the "Indocyanine Green" (0.5mg/kg) within 30 seconds.
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
| 1 | months-old | <= |
Age-upper limit
| 4 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Children with intractable jaundice, with possible diagnosis of biliary atresia.
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Go Miyano |
Organization
Juntendo University School of Medicine
Division name
Pediatric Surgery
Zip code
Address
2-1-1 Hongo, Bunkyo-ku Tokyo
TEL
03-3813-3111
go@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Go Miyano |
Organization
Juntendo University School of Medicine
Division name
Pediatric Surgery
Zip code
Address
2-1-1 Hongo, Bunkyo-ku Tokyo
TEL
03-3813-3111
Homepage URL
go@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
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
Address
Tel
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 | 07 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | 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 | 06 | Month | 28 | Day |
Last modified on
| 2018 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032042
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| Registered date | File name |
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| Registered date | File name |
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