UMIN-CTR Clinical Trial

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023828
Receipt No. 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 (Ver. 4)

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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
Email 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
Email kinami@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027453