UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029864 |
|---|---|
| Receipt number | 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 15:35:44 |
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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
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
rtoda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033030
