UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Biopsy from suspected malignant biliary strictures by using peroral cholangioscopy or EUS-FNA according to the stricture location
Title of the study (Brief title)	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	Jong Ho Moon
Organization	SoonChunHyang University School of Medicine
Division name	Digestive Disease Center and Research Institute, Department of Internal Medicine
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	Yun Nah Lee
Organization	SoonChunHyang University School of Medicine
Division name	Digestive Disease Center and Research Institute, Department of Internal Medicine
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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