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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016886
Receipt No. R000019187
Scientific Title Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture
Date of disclosure of the study information 2015/03/23
Last modified on 2016/07/19

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Basic information
Public title Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture
Acronym Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture
Scientific Title Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture
Scientific Title:Acronym Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture
Region
Asia(except Japan)

Condition
Condition Malignant bile duct stricture
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 evaluate the usefulness of a diagnostic approach using ERCP-guided transpapillary forceps biopsy (TPB) or EUS-guided fine needle aspiration biopsy (EUS-FNAB) according to the characteristics of the strictured segment in patients with suspected MBS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes the accuracy of the diagnostic approach using ERCP-guided TPB and EUS-FNAB according to the type of biliary stricture in patients with suspected MBS
Key secondary outcomes the accuracy of initial TPB, technical failure and adverse event rates of ERCP-guided TPB and EUS-FNAB

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 EUS-guided fine-needle aspiration biopsy
Interventions/Control_2 Transpapillary forceps 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
100 years-old >
Gender Male and Female
Key inclusion criteria (1) the presence of biliary stricture due to a thickened bile duct wall or pancreatobiliary mass revealed by cross-sectional radiologic images, computed tomography (CT), and/or magnetic resonance imaging (MRI), (2) clinical findings of obstructive jaundice and/or cholangitis, (3) age >18 years, and (4) ability to provide informed consent.
Key exclusion criteria (1) underlying pancreatobiliary disease without clinical findings suggestive of malignancy (e.g., primary biliary cirrhosis or postoperative biliary stricture), (2) the presence of any contraindication for ERCP, (3) coagulopathy (international normalized ratio >1.5 or platelet count <80,000/mm3 (4) difficulty to perform ERCP due to altered gastrointestinal anatomy or a significant duodenal obstruction.
Target sample size 174

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jong Ho Moon
Organization Digestive Disease Center and Research Institute, Department of Internal Medicine, Soon Chun Hyang University School of Medicine
Division name Gastroenterology
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 Hyun Jong Choi
Organization Department of Internal Medicine, Soon Chun Hyang University School of Medicine
Division name Gastroenterology
Zip code
Address Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Joma
TEL +82-32-621-5094
Homepage URL
Email joseph@schmc.ac.kr

Sponsor
Institute SoonChunHyang University
Institute
Department

Funding Source
Organization SoonChunHyang 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
2015 Year 03 Month 23 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
2012 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 11 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
2015 Year 03 Month 23 Day
Last modified on
2016 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019187

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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