UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035482 |
|---|---|
| Receipt number | R000037548 |
| Scientific Title | Accuracy of the dissection line during anatomic liver resection guided by a fluorescence color image from the improved intraoperative projector machine |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2019/09/11 09:10:24 |
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Basic information
Public title
Accuracy of the dissection line during anatomic liver resection guided by a fluorescence color image from the improved intraoperative projector machine
Acronym
Accuracy of the dissection line during anatomic liver resection guided by a fluorescence color image from the improved intraoperative projector machine (MIPS5)
Scientific Title
Accuracy of the dissection line during anatomic liver resection guided by a fluorescence color image from the improved intraoperative projector machine
Scientific Title:Acronym
Accuracy of the dissection line during anatomic liver resection guided by a fluorescence color image from the improved intraoperative projector machine (MIPS5)
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 accuracy of the dissection line during anatomic liver resection guided by a fluorescence color image from the improved intraoperative projector machine
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The fluorescence area ratio of both resected and remnant liver using conventional near-infrared fluorescence color system
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
To use the unapproved projector machine using a fluorescence color system
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
An anatomic left trisectionectomy, a right hepatectomy, a left hepatectomy or a right posterior sectionectomy was planned.
Written informed consent.
Key exclusion criteria
Pregnancy or suspicion of pregnancy.
History of hypersensitivity to ICG.
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Seo |
Organization
Kyoto University Hospital
Division name
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
6068507
Address
54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL
075-751-3242
rutosa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Nishino |
Organization
Kyoto University Hospital
Division name
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
6068507
Address
54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL
075-751-3242
Homepage URL
hnishino@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Institute
Department
Personal name
Funding Source
Organization
Panasonic Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mitaka Kohki Co.,Ltd.
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
YES
Study ID_1
jRCTs052180025
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | 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
2
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
| 2019 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 29 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 29 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 29 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 08 | Day |
Last modified on
| 2019 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037548
