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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020192
Receipt No. R000023320
Scientific Title The Usefulness of IDUS Guided Transpapillary Bile Duct Biopsy for the Diagnosis of Suspected Malignant Biliary Strictures
Date of disclosure of the study information 2017/01/07
Last modified on 2017/01/07

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Basic information
Public title The Usefulness of IDUS Guided Transpapillary Bile Duct Biopsy for the Diagnosis of Suspected Malignant Biliary Strictures
Acronym The Usefulness of IDUS Guided Transpapillary Bile Duct Biopsy for the Diagnosis of Suspected Malignant Biliary Strictures
Scientific Title The Usefulness of IDUS Guided Transpapillary Bile Duct Biopsy for the Diagnosis of Suspected Malignant Biliary Strictures
Scientific Title:Acronym The Usefulness of IDUS Guided Transpapillary Bile Duct Biopsy for the Diagnosis of Suspected Malignant Biliary Strictures
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 diagnostic yields of IDUS-guided transpapillary bile duct biopsy compared with fluoroscopy-guided biopsy in patients with suspected MBS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the accuracy of the IDUS-guided TPB and fluoroscopy-guided TPB in patients with suspected MBS.
Key secondary outcomes

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 IDUS guided transpapillary bile duct biopsy
Interventions/Control_2 Fluoroscopically guided transpapillary bile duct biopsy
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
99 years-old >=
Gender Male and Female
Key inclusion criteria (1) clinical presentation that consistent with a biliary stricture (e.g., jaundice), (2) evidence of biliary stricture on imaging studies, including abdominal ultrasonography (US) and/or computed tomography (CT), (3) the diameter of the common bile duct (CBD) of 8 mm or more, (4) age older than 18 years and (5) ability to provide informed consent
Key exclusion criteria 1) diagnosed as definite benign disease by routine examinations including abdominal US and CT, (2) lesions invading periampullary area, (3) history of previous biliary surgery except cholecystectomy, and (4) the presence of any contraindication to ERCP
Target sample size 65

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
2017 Year 01 Month 07 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
2009 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2015 Year 08 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 03 Month 03 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 14 Day
Last modified on
2017 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023320

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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