UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027841 |
|---|---|
| Receipt number | R000027619 |
| Scientific Title | Evaluarion of the usefulness of indocyanine green fluorescence imaging in pancreatic surgery. |
| Date of disclosure of the study information | 2017/06/21 |
| Last modified on | 2018/12/21 11:21:41 |
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Basic information
Public title
Evaluarion of the usefulness of indocyanine green fluorescence imaging in pancreatic surgery.
Acronym
Fluorescence imaging for pancreatic surgery.
Scientific Title
Evaluarion of the usefulness of indocyanine green fluorescence imaging in pancreatic surgery.
Scientific Title:Acronym
Fluorescence imaging for pancreatic surgery.
Region
| Japan |
Condition
Condition
pancreatic cancer, cystic tumor in pancreas, neuroendocrine tumor, intrapapillary mucinous neoplasm, Solid pseudopapillary neoplasm
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of indocyanine green fluorescence imaging for pancreatic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary outcome is to assess fluorescence pattern of pancreatic lesion.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Objictives:pancreatic cancer, pancreatic neuroendocrine tumor, intrapapillaly mucinous neoplasm, solid pseudopapillaly neoplasm
1)patient 20 years old or older.
2)patient who receive enough explanation, understand enough, and can agree with the study of their own accord.
Key exclusion criteria
1)there is an allergy carrer for indocyanine green.
2)there is an allergy carrer for iodine .
3)The patient who is judged to be inappropriate from medical grounds.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
+81338155411
KOKUDO-2SU@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chikara Shirata |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
+81338155411
Homepage URL
shiratac-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
University of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 06 | Month | 21 | 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
Results
We evaluated the usefulness of fluorescence imaging using indocyanine green to identify pancreas tumors in 23 patients undergoing pancreas resection. This technique was useful in visualizing pancreas lesions during surgery, specifically, neuroendocrine tumors as fluorescence and cystic neoplasms as a fluorescence defect.
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 | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 11 | Month | 01 | Day |
Other
Other related information
not applicable
Management information
Registered date
| 2017 | Year | 06 | Month | 20 | Day |
Last modified on
| 2018 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027619
