UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Usefulness of IDUS Guided Transpapillary Bile Duct Biopsy for the Diagnosis of Suspected Malignant Biliary Strictures
Title of the study (Brief title)	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	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	2017 Year 01 Month 07 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2009 Year 02 Month 20 Day
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

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 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