UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024126
Receipt No. R000027776
Scientific Title Research for intraoperative navigation by ICG fluorescence imaging in laparoscopic liver resection
Date of disclosure of the study information 2016/11/01
Last modified on 2019/03/25

* 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 Research for intraoperative navigation by ICG fluorescence imaging in laparoscopic liver resection
Acronym Intraoperative navigation by ICG fluorescence imaging in laparoscopic liver resection
Scientific Title Research for intraoperative navigation by ICG fluorescence imaging in laparoscopic liver resection
Scientific Title:Acronym Intraoperative navigation by ICG fluorescence imaging in laparoscopic liver resection
Region
Japan

Condition
Condition Hepatocellular carcinoma, Colorectal liver metastasis, Liver tumor
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of intraoperative navigation by ICG fluorescence imaging in laparoscopic liver resection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Success rate of the visualization of liver tumor by ICG fluorescence imaging.
Key secondary outcomes Success rate of the visualization of boundary between hepatic segment by ICG fluorescence imaging in laparoscopic anatomical liver resection.

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
Interventions/Control_1 intravenous administration of ICG
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have liver tumors that is surgical indication and can be adapted laparoscopic liver resection
Key exclusion criteria Patients who are contraindication for taking ICG
Target sample size 100

Research contact person
Name of lead principal investigator
1st name DAISUKE
Middle name
Last name HOKUO
Organization Nara Medical University
Division name Department of surgery
Zip code 634-8522
Address 840-Shijo-cho, Kasihara City, Nara, Japan
TEL 0744223051
Email hokuto@naramed-u.ac.jp

Public contact
Name of contact person
1st name DAISUKE
Middle name
Last name HOKUO
Organization Nara Medical University
Division name Department of surgery
Zip code 634-8522
Address 840-Shijo-cho, Kasihara City, Nara, Japan
TEL 0744-22-3051
Homepage URL
Email hokuto@naramed-u.ac.jp

Sponsor
Institute Department of surgery, Nara Medical University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nara Medical University Ethics Committee
Address 840-Shijo-cho, Kasihara City, Nara, Japan
Tel 0744-22-3051
Email ino_rinri@naramed-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
2016 Year 11 Month 01 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 10
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
2016 Year 09 Month 21 Day
Date of IRB
2016 Year 01 Month 25 Day
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2018 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
2016 Year 09 Month 21 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027776

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.