UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024126 |
|---|---|
| Receipt number | R000027776 |
| Scientific Title | Research for intraoperative navigation by ICG fluorescence imaging in laparoscopic liver resection |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2019/03/25 11:33:42 |
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Basic information
Public title
Research for intraoperative navigation by ICG fluorescence imaging in laparoscopic liver resection
Acronym
Intraoperative navigation by ICG fluorescence imaging in laparoscopic liver resection
Scientific Title
Research for intraoperative navigation by ICG fluorescence imaging in laparoscopic liver resection
Scientific Title:Acronym
Intraoperative navigation by ICG fluorescence imaging in laparoscopic liver resection
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma, Colorectal liver metastasis, Liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of intraoperative navigation by ICG fluorescence imaging in laparoscopic liver resection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of the visualization of liver tumor by ICG fluorescence imaging.
Key secondary outcomes
Success rate of the visualization of boundary between hepatic segment by ICG fluorescence imaging in laparoscopic anatomical liver resection.
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 administration of ICG
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 who have liver tumors that is surgical indication and can be adapted laparoscopic liver resection
Key exclusion criteria
Patients who are contraindication for taking ICG
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | DAISUKE |
| Middle name | |
| Last name | HOKUO |
Organization
Nara Medical University
Division name
Department of surgery
Zip code
634-8522
Address
840-Shijo-cho, Kasihara City, Nara, Japan
TEL
0744223051
hokuto@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | DAISUKE |
| Middle name | |
| Last name | HOKUO |
Organization
Nara Medical University
Division name
Department of surgery
Zip code
634-8522
Address
840-Shijo-cho, Kasihara City, Nara, Japan
TEL
0744-22-3051
Homepage URL
hokuto@naramed-u.ac.jp
Sponsor or person
Institute
Department of surgery, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University Ethics Committee
Address
840-Shijo-cho, Kasihara City, Nara, Japan
Tel
0744-22-3051
ino_rinri@naramed-u.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
| 2016 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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 | 21 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2016 | Year | 09 | Month | 21 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027776
