UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012672 |
|---|---|
| Receipt number | R000014808 |
| Scientific Title | A prospective study to investigate efficacy of ICG fluorography as an intraoperative navigator for heparobiliary-pancreatic surgery. |
| Date of disclosure of the study information | 2013/12/26 |
| Last modified on | 2019/01/06 10:09:17 |
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Basic information
Public title
A prospective study to investigate efficacy of ICG fluorography as an intraoperative navigator
for heparobiliary-pancreatic surgery.
Acronym
ICG navi-surgery study
Scientific Title
A prospective study to investigate efficacy of ICG fluorography as an intraoperative navigator
for heparobiliary-pancreatic surgery.
Scientific Title:Acronym
ICG navi-surgery study
Region
| Japan |
Condition
Condition
The primary and metastatic liver cancer, pancreatic cancer, biliary cancer.
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of hepatobiliary-pancreatic surgery navigated by ICG fluorescence imaging (ICGF).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)The staining performance of ICGF when applied to anatomical resection of the liver.
2)The efficacy of intraoperative angiography of splanchnic vessels using ICGF.
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
Diagnosis
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
1)Using Near-inflared ray camera system, ICG fluorescence imaging (ICGF) is performed after bolus injectino of 2.5mg ICG. The subject of ICGF is 1) Regional liver staining with ICG 2) angiography of splanchnic vessels around the pancreatic head and hepatoduodenal ligament.
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
1) Patients who are candidate of anatomical liver resection.
2) Patients who are candidate of pancreatic resection accompanied with dissection around pancreas and superior mesenteric artery.
3) patients who are candidate of hepatobiliary-pancreatic surgery accompanied with arterial or portal resection and reconstruction.
Key exclusion criteria
Patients with allergic history to iodinated contrast material or ICG itself.
Patients with severely impaired liver function or cirrhosis.
Patients who are not considered to be eligible to this trial.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Inoue |
Organization
Japanese foundation for cancer research, Cancer institute hospital
Division name
The dept of digestive and HBP surgery
Zip code
Address
3-8-31, Ariake, Koto-ku, Tokyo
TEL
+81-3-3520-0111
sukeyaubj@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Inoue |
Organization
Japanese foundation for cancer research, Cancer institute hospital
Division name
The dept of digestive and HBP surgery
Zip code
Address
3-8-31, Ariake, Koto-ku, Tokyo
TEL
+81-3-3520-0111
Homepage URL
sukeyaubj@yahoo.co.jp
Sponsor or person
Institute
Japanese foundation for cancer research, Cancer institute hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese foundation for cancer research, Cancer institute hospital
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2013 | Year | 12 | Month | 26 | 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
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
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | 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
| 2013 | Year | 12 | Month | 24 | Day |
Last modified on
| 2019 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014808
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
