UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030488 |
|---|---|
| Receipt number | R000034807 |
| Scientific Title | Intraoperative evaluation of blood flow using idocyanine green fluorescence imaging in surgery for biliary-pancreatic cancer |
| Date of disclosure of the study information | 2017/12/21 |
| Last modified on | 2023/06/30 19:04:59 |
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Basic information
Public title
Intraoperative evaluation of blood flow using idocyanine green fluorescence imaging in surgery for biliary-pancreatic cancer
Acronym
Intraoperative evaluation of blood flow using idocyanine green fluorescence imaging in surgery for biliary-pancreatic cancer
Scientific Title
Intraoperative evaluation of blood flow using idocyanine green fluorescence imaging in surgery for biliary-pancreatic cancer
Scientific Title:Acronym
Intraoperative evaluation of blood flow
using ICG for biliary-pancreatic cancer
Region
| Japan |
Condition
Condition
biliary-pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the systematic lymph node dissection for biliary-pancreatic cancer using
ICG imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the number of dissected lymph node
Key secondary outcomes
the ratio of lymph node matastasis
operative time
intraoperative bleeding
morbidity
outcome
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
1) Intraoperative administration
Direct injection of 0.2ml of ICG solution at parenchyma close to cancer with a 27-gauge needle.
2) Intraoperatice administration
Intraoperative administration using endoscope: injection of a 0.2ml 0f 0.5% ICG solution at parenchyma close to cancer
3) Preoperative administration using endoscope: Injection of a 0.2ml of 0.5% ICG solution at parenchyma close to cancer
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patiets who need pancreaticoduodenectomy, or distal pancreatic rescection, or bile duct resection.
Key exclusion criteria
1) Patients with iodine allergy
2) Patients with ICG allergy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Okamoto |
| Middle name | |
| Last name | Tomoyoshi |
Organization
Jikei University School of Medicine Daisan Hospital
Division name
Depatment of surgery
Zip code
2018601
Address
4-11-1 Izumihoncho, Komae city, Tokyo, Japan
TEL
03-3480-1151
tomoka@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Futagawa |
| Middle name | |
| Last name | Yasuro |
Organization
Jikei University School of Medicine Daisan Hospital
Division name
Depatment of surgery
Zip code
2018601
Address
4-11-1 Izumihoncho, Komae city, Tokyo, Japan
TEL
03-3480-1151
Homepage URL
tiger@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University School of Medicine
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
The Jikei University School of Medicine
Address
3-25-8 Nishishinbashi, Minato-KU, Tokyo, Japan
Tel
0334331111
rinri@jikei.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
東京慈恵会医科大学附属第三病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 21 | 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
41
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
no complications
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 20 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034807
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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