UMIN-CTR Clinical Trial

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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