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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004712
Receipt No. R000005607
Scientific Title Peroral cholangioscopy for preoperative diagnosis of biliary cancer
Date of disclosure of the study information 2011/02/01
Last modified on 2013/12/16

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Basic information
Public title Peroral cholangioscopy for preoperative diagnosis of biliary cancer
Acronym POCS for preoperative diagnosis of biliary cancer
Scientific Title Peroral cholangioscopy for preoperative diagnosis of biliary cancer
Scientific Title:Acronym POCS for preoperative diagnosis of biliary cancer
Region
Japan

Condition
Condition Biliary cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Peroral Cholangioscopy(POCS) for preoperative diagnosis of biliary cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Peroral Cholangioscopy(POCS) for preoperative diagnosis of biliary cancer
Key secondary outcomes Efficacy of narrow band imaging

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

Not applicable
Gender Male and Female
Key inclusion criteria Biliary cancer
Key exclusion criteria 1)Platelet count >= 50,000/mm3,
PT-INR <= 1.5,
2)Patients who gives written informed consent.
3)Patients considered ineligible for this study.
4)Patients for whom endoscopic biliary drainage is difficult
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio TSUYUGUCHI
Organization Graduate School of Medicine, Chiba University
Division name Department of Medicine and Clinical Oncology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL 043-226-2083
Email sakai4754@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji SAKAI
Organization Chiba University Hospital
Division name Department of Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL 043-222-7171
Homepage URL
Email sakai4754@yahoo.co.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Graduate School of Medicine, Chiba University
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
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
2011 Year 02 Month 01 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 Completed
Date of protocol fixation
2010 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 01 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 Not particular

Management information
Registered date
2010 Year 12 Month 12 Day
Last modified on
2013 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005607

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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