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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029864
Receipt No. R000033030
Scientific Title Efficacy of fluorescence navigation surgery for laparoscopic liver resection
Date of disclosure of the study information 2017/12/01
Last modified on 2019/05/10

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Basic information
Public title Efficacy of fluorescence navigation surgery for laparoscopic liver resection
Acronym Efficacy of fluorescence navigation surgery for laparoscopic liver resection (laparo-fluorescence)
Scientific Title Efficacy of fluorescence navigation surgery for laparoscopic liver resection
Scientific Title:Acronym Efficacy of fluorescence navigation surgery for laparoscopic liver resection (laparo-fluorescence)
Region
Japan

Condition
Condition Liver tumors
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of fluorescence navigation surgery for liver resection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The concordance rate between demarcation line presented by fluorescence image and preoperative simulation image in anatomic 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
Medicine
Interventions/Control_1 Administration of 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
90 years-old >
Gender Male and Female
Key inclusion criteria A laparoscopic liver resection was planned.

Written informed consent.
Key exclusion criteria Pregnancy or suspicion of pregnancy.

History of hypersensitivity to ICG.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Satoru
Middle name
Last name Seo
Organization Graduate School of Medicine, Kyoto University
Division name Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code 6068507
Address 54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL 075-751-3608
Email rutosa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Rei
Middle name
Last name Toda
Organization Graduate School of Medicine, Kyoto University
Division name Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code 6068507
Address 54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL 075-751-3608
Homepage URL
Email rtoda@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Kyoto University
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Institute
Department

Funding Source
Organization Self funding
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 Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address Yoshidakonoecho Sakyo-ku Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-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
2017 Year 12 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 08 Day
Date of IRB
2017 Year 11 Month 09 Day
Anticipated trial start date
2017 Year 12 Month 26 Day
Last follow-up date
2020 Year 01 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 07 Day
Last modified on
2019 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033030

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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