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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027841
Receipt No. 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

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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
Email 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
Email shiratac-tky@umin.ac.jp

Sponsor
Institute University of Tokyo
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027619

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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