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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025678
Receipt No. R000029540
Scientific Title Examination of the usefulness of probe type confocal laser endomicroscopy for duodenum, biliary tract system and pancreas disease.
Date of disclosure of the study information 2017/01/14
Last modified on 2017/07/16

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Basic information
Public title Examination of the usefulness of probe type confocal laser endomicroscopy for duodenum, biliary tract system and pancreas disease.
Acronym Examination of the usefulness of probe type confocal laser endomicroscopy for duodenum, biliary tract system and pancreas disease.
Scientific Title Examination of the usefulness of probe type confocal laser endomicroscopy for duodenum, biliary tract system and pancreas disease.
Scientific Title:Acronym Examination of the usefulness of probe type confocal laser endomicroscopy for duodenum, biliary tract system and pancreas disease.
Region
Japan

Condition
Condition duodenum, biliary tract system and pancreas disease.
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness of probe type confocal laser endomicroscopy for duodenum, biliary tract system and pancreas disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison with pathology views
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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Observation of probe type confocal laser endomicroscopy
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 Ampullary of vater tumor patients who is planned endoscopic observation or papillectomy.
Key exclusion criteria Patients who refused the entry of this study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eisuke Iwasaki
Organization Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology,Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-3353-1211
Email e-iwa@sunny.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Minami
Organization Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology,Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email e-iwa@sunny.ocn.ne.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization None
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 01 Month 14 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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 07 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
2017 Year 01 Month 14 Day
Last modified on
2017 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029540

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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