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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044509
Receipt No. R000050851
Scientific Title Research on bile duct biopsy for biliary tract diseases
Date of disclosure of the study information 2021/07/01
Last modified on 2021/06/22

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Basic information
Public title Research on bile duct biopsy for biliary tract diseases
Acronym Research on bile duct biopsy for biliary tract diseases
Scientific Title Research on bile duct biopsy for biliary tract diseases
Scientific Title:Acronym Research on bile duct biopsy for biliary tract diseases
Region
Japan

Condition
Condition Extrahepatic bile duct cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the results and safety of biopsy for bile duct stenosis using an endoscopic introducer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Success rate of Mapping Biopsy using endoscopic introducer (success rate of biopsy of targeted bile duct branch against expected operation)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Bile duct biopsy using an endoscopic introducer
Interventions/Control_2 Bile duct biopsy without an endoscopic introducer
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 Patients who are suspected of having bile duct stenosis by imaging diagnosis such as CT or MRI and require ERCP.
Patients who have given written consent to participate in this study.
Key exclusion criteria Patients with poorly controlled infections.
Patients with severe drug allergy.
Pregnant or potentially pregnant and lactating women.
Patients with severe mental disorders.
Cases that the principal investigator or sub-investigator deems inappropriate for the safe conduct of this study.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Kawashima
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code 4668550
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 0527442602
Email h-kawa@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Kenta
Middle name
Last name Yamada
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code 4668550
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 0527442602
Homepage URL
Email kentaymd@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nagoya 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 Ethics Committee
Address 65, Tsuruma-cho, Showa-ku, Nagoya
Tel 0527412111
Email ethics@med.nagoya-u.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
2021 Year 07 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 Preinitiation
Date of protocol fixation
2021 Year 06 Month 11 Day
Date of IRB
Anticipated trial start date
2021 Year 07 Month 01 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 11 Day
Last modified on
2021 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050851

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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