UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026474 |
|---|---|
| Receipt number | R000030334 |
| Scientific Title | Clinical study of navigation surgery for hepatoblastoma using Indocyanine Green (ICG) |
| Date of disclosure of the study information | 2017/03/10 |
| Last modified on | 2018/03/15 13:09:00 |
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Basic information
Public title
Clinical study of navigation surgery for hepatoblastoma using Indocyanine Green (ICG)
Acronym
Clinical study of navigation surgery for hepatoblastoma using Indocyanine Green (ICG)
Scientific Title
Clinical study of navigation surgery for hepatoblastoma using Indocyanine Green (ICG)
Scientific Title:Acronym
Clinical study of navigation surgery for hepatoblastoma using Indocyanine Green (ICG)
Region
| Japan |
Condition
Condition
Hepatoblastoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of ICG-guided surgery to achieve complete resection of hepatoblastomas, which are not visible by current image modalities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological accuracy of the specimens that are positive for ICG
Key secondary outcomes
To prove the non-inferiority of ICG navigation surgery compared with current available image modalities, and survival proportions in 1,3,5 years after the 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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous injection of ICG 0.5mg/kg, 24-72 hours before the operation.
Visualization of lesions taking up ICG by a fluorescent camera at the time of operation.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients suspected with primary or metastatic hepatoblastoma
Key exclusion criteria
Ones who are allergic to ICG or Iodine or who are ineligible for surgery are excluded.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kuroda |
Organization
Keio University School of Medicine
Division name
The department of pediatric surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL
+81-3-5363-3024
kuroda-t@z8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teizaburo Mori |
Organization
Keio University School of Medicine
Division name
The department of pediatric surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL
+81-3-5363-3024
Homepage URL
0105mori@keio.jp
Sponsor or person
Institute
Keio University School of Medicine, the department of pediatric surgery
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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
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
慶応義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 10 | 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 | 03 | Month | 09 | Day |
Last modified on
| 2018 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030334
