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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020193
Receipt No. R000023321
Scientific Title Biopsy from suspected malignant biliary strictures by using peroral cholangioscopy or EUS-FNA according to the stricture location
Date of disclosure of the study information 2016/12/31
Last modified on 2017/08/23

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Basic information
Public title Biopsy from suspected malignant biliary strictures by using peroral cholangioscopy or EUS-FNA according to the stricture location
Acronym Peroral cholangioscopy or EUS-guided biopsy for diagnosis of biliary stricture
Scientific Title Biopsy from suspected malignant biliary strictures by using peroral cholangioscopy or EUS-FNA according to the stricture location
Scientific Title:Acronym Peroral cholangioscopy or EUS-guided biopsy for diagnosis of biliary stricture
Region
Asia(except Japan)

Condition
Condition Malignant Biliary Stricture
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of a diagnostic approach using POC-guided forceps biopsy or EUS-FNAB according to the location of stricture in suspected MBS
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic accuracy of POC-guided biopsy and EUS-FNAB for indeterminate biliary stricture
Key secondary outcomes Accuracy of initial TPB
Procedure technical success
Diagnostic yields of POC-guided biopsy and EUS-FNAB for indeterminate biliary stricture
Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 POC-guided intraductal forceps biopsy for indeterminate MBS in proximal bile duct
Interventions/Control_2 EUS-guided FNAB for indeterminate MBS in distal bile duct
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
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria 1. Suspected MBS diagnosed by cross sectional imaging study
2. Clinical findings of obstructive jaundice and/or cholangitis
Key exclusion criteria 1. Bleeding tendency (INR>1.5 or platelet count < 60,000/mm3)
2. Inability to give informed consent
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jong Ho Moon
Organization SoonChunHyang University School of Medicine
Division name Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
Address Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea
TEL +82-32-621-5094
Email jhmoon@schmc.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Yun Nah Lee
Organization SoonChunHyang University School of Medicine
Division name Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
Address Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Joma
TEL +82-32-621-5094
Homepage URL
Email yunnah@schmc.ac.kr

Sponsor
Institute SoonChunHyang University School of Medicine
Institute
Department

Funding Source
Organization SoonChunHyang University School of Medicine
Organization
Division
Category of Funding Organization Non profit foundation
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
2016 Year 12 Month 31 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 No longer recruiting
Date of protocol fixation
2014 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 24 Day
Last follow-up date
2016 Year 06 Month 08 Day
Date of closure to data entry
2017 Year 01 Month 04 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 14 Day
Last modified on
2017 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023321

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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