UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031054 |
|---|---|
| Receipt number | R000035461 |
| Scientific Title | Evaluation of fluorescence imaging with indocyanine green during hepatectomy |
| Date of disclosure of the study information | 2018/02/08 |
| Last modified on | 2021/02/04 12:51:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of fluorescence imaging with indocyanine green during hepatectomy
Acronym
Evaluation of fluorescence imaging with indocyanine green during hepatectomy
Scientific Title
Evaluation of fluorescence imaging with indocyanine green during hepatectomy
Scientific Title:Acronym
Evaluation of fluorescence imaging with indocyanine green during hepatectomy
Region
| Japan |
Condition
Condition
Hepatic tumors
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of the intraoperative navigation using indocyanine green during hepatectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Availability of the detection of liver segment with indocyanine green during anatomical liver resection
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1.Injection of indocyanine green before the operation (0.5mg/kg)
2.Assess the availability of detection of anatomical border by indocyanine green
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 with 20 years or older with written informed consent
2. Hepatic tumors proven pathologically
3. Patients who are eligible for hepatectomy
Key exclusion criteria
1. Patients who have allergy with indocyanine grenn
2. When doctors judge as inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Fukumoto |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
+81783826302
komasho8@gmail.com
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Kido |
Organization
Kobe universtiy
Division name
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
+81783826302
Homepage URL
komasho8@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine
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
Kobe University Graduate School of Medicine
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel
078-382-6302
kansatsu@med.kobe-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
| 2018 | Year | 02 | Month | 08 | 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
54
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 | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 01 | Month | 29 | Day |
Last modified on
| 2021 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035461
