UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027725 |
|---|---|
| Receipt number | R000031761 |
| Scientific Title | The safety of laparoscopic ICG fluorescence imaging surgery |
| Date of disclosure of the study information | 2017/06/14 |
| Last modified on | 2020/12/14 11:08:19 |
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Basic information
Public title
The safety of laparoscopic ICG fluorescence imaging surgery
Acronym
The safety of laparoscopic ICG fluorescence imaging surgery
Scientific Title
The safety of laparoscopic ICG fluorescence imaging surgery
Scientific Title:Acronym
The safety of 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 safety of the ICG fluorescence imaging surgery in gastroenterologic surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
The occurrence of the adverse effect of ICG
Key secondary outcomes
operative method, operative time, blood loss, postoperative comlication, others
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, the obsevation is performed under ICG fluorescence image-navigation using an image-enhanced laparoscopy.
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) The following operation:Thoracoscopic esophagectomy, Laparoscopic gastrectomy, Laparoscopy and endoscopy cooperative surgery, Laparoscopic enterectomy, Laparoscopic coloctomy, Laparoscopic proctectomy, Laparoscopic abdominoperineal resection, Laparoscopic colecystectomy, Laparoscopic common bile duct exploration, Laparoscopic hepatectomy, Laparoscopic derooting for liver cyst.
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 | Toshikatsu |
| Middle name | |
| Last name | Tsuji |
Organization
Ishikawa prefectural central hospital
Division name
Department of Gastroenterological Surgery
Zip code
920-8530
Address
2-1, Kuratsukihigashi, Kanazawa, Ishiwaka 920-8530 Japan
TEL
+81-76-237-8211
toshi_toshi25@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Toshikatsu |
| Middle name | |
| Last name | Tsuji |
Organization
Ishikawa prefectural central hospital
Division name
Department of Gastroenterological Surgery
Zip code
920-8530
Address
2-1, Kuratsukihigashi, Kanazawa, Ishiwaka 920-8530 Japan
TEL
+81-76-237-8211
Homepage URL
toshi_toshi25@yahoo.co.jp
Sponsor or person
Institute
Ishikawa prefectural central hospital
Institute
Department
Personal name
Funding Source
Organization
Ishikawa prefectural central hospital
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
Ishikawa prefectural central hospital
Address
2-1, Kuratsukihigashi, Kanazawa, Ishiwaka 920-8530 Japan
Tel
+81-76-237-8211
tmurai@ipch.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
石川県立中央病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 14 | 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
| 2017 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 12 | Day |
Last modified on
| 2020 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031761
