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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003654
Receipt No. R000004423
Scientific Title Identification of pancreatic juice and bile using newly developed fluorescence probes
Date of disclosure of the study information 2010/06/01
Last modified on 2019/06/15

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Basic information
Public title Identification of pancreatic juice and bile using newly developed fluorescence probes
Acronym Fluorescence imaging of pancreatic juice and bile
Scientific Title Identification of pancreatic juice and bile using newly developed fluorescence probes
Scientific Title:Acronym Fluorescence imaging of pancreatic juice and bile
Region
Japan

Condition
Condition Pancreatic tumors, hepatobiliary tumors
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To develop fluorescence probes identifying pancreatic juice and bile during surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sensitivity and specificity of fluorescence probes for identifying pancreatic juice and bile

Key secondary outcomes Diagnostic ability of detection of pancreatic juice by fluorescence imaging for postoperative pancreatic fistula and bile leaks

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 Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Administration of fluorescence probes on resected specimen and drained abdominal fluids
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are to undergo pancreatic surgeries or hepatobiliary surgeries
Key exclusion criteria None
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Kiyoshi
Middle name
Last name Hasegawa
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-3815-5411
Email kihase-tky@umin.ac.jp

Public contact
Name of contact person
1st name Takeaki
Middle name
Last name ISHIZAWA
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email tish-tky@umin.ac.jp

Sponsor
Institute Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,
Graduate School of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization None
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 Research Ethics Committee, Graduate School of Medicine and Faculty of Medicine, the University of Tokyo
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel 03-5841-0818
Email liaison@m.u-tokyo.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
2010 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2010 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 05 Month 24 Day
Last modified on
2019 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004423

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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