UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023828 |
|---|---|
| Receipt number | R000027453 |
| Scientific Title | The feasibility study for laparoscopic ICG fluorescence imaging navigated surgery. |
| Date of disclosure of the study information | 2016/08/29 |
| Last modified on | 2020/03/08 12:32:20 |
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Basic information
Public title
The feasibility study for laparoscopic ICG fluorescence imaging navigated surgery.
Acronym
Laparoscopic ICG fluorescence imaging surgery.
Scientific Title
The feasibility study for laparoscopic ICG fluorescence imaging navigated surgery.
Scientific Title:Acronym
Laparoscopic ICG fluorescence imaging surgery.
Region
| Japan |
Condition
Condition
All diseases suitable for gastroenterologic surgery.
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the feasibility and reliability of the ICG fluorescence imaging navigation using image-enhanced laparoscopy in various surgeries.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The detection rate of the target. Or, the occurrence rate of the anastomotic leakage or necrosis of the graft.
Key secondary outcomes
The occurrence of the adverse effect of ICG, such as the allergic reaction for ICG, incidences during the injection of ICG, or postoperative complications related to ICG.
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 |
Interventions/Control_1
The subject of this study is almost all laparoscopic surgeries. After the administration of ICG intraoperatively, detection of arteries, veins, bile ducts, lymphatics, thoracic ducts, ureter, or sentinel nodes are performed under ICG fluorescence image-navigation using an image-enhanced laparoscopy. The estimation of blood supply, localization of the tumor, and detection of bile leakage are also performed. After the observation, the standard surgical approach is conducted.
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) Suitable for surgery under general anesthesia.
2) Over 20 years old.
3) Having a potential demand for a detection of vessels, arteries, bile ducts, or lymphatics under the fatty layer.
4) Having a potential demand for a detection of a location of a tumor.
5) having a potential demand for a estimation of blood supply.
Key exclusion criteria
1) Having allergy for ICG.
2) Having allergy for iodic contrast medium.
3) Having allergy for various drugs.
4) Having psychological or neurological disease.
5) difficult to draw an informed consent.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Kosaka |
Organization
Kanazawa Medical University
Division name
Dept. of Surgical Oncology
Zip code
9200293
Address
1-1 Daigaku, Uchinada, Kahoku, Ishiwaka 920-0293 Japan
TEL
+81-76-286-2211
kinami@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Kinami |
Organization
Kanazawa Medical University
Division name
Dept. of Surgical Oncology
Zip code
9200293
Address
1-1 Daigaku, Uchinada, Kahoku, Ishiwaka 920-0293 Japan
TEL
+81-76-286-2211
Homepage URL
kinami@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
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
Kanazawa Medical University
Address
1-1 Daigaku, Uchinada, Kahoku, Ishiwaka 920-0293 Japan
Tel
+81-76-286-2211
kinami@kanazawa-med.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
金沢医科大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 29 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000027453
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000027453
Number of participants that the trial has enrolled
50
Results
Now continuing
Results date posted
| 2020 | Year | 03 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
surgical cases
Participant flow
follow up
Adverse events
no
Outcome measures
detection rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2018 | Year | 03 | 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 | 08 | Month | 29 | Day |
Last modified on
| 2020 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027453
