UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective multicenter study to evaluate utility of EUS-guided rendezvous method in cases of difficult biliary cannulation
Title of the study (Brief title)	Prospective multicenter study to evaluate utility of EUS-guided rendezvous method in cases of difficult biliary cannulation
Region	Japan

Condition
Condition	biliary diseases
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of EUS-guided rendezvous method in cases of difficult biliary cannulation during therapeutic ERCP for biliary diseases.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Technical success rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	EUS-guided rendezvous methd
Interventions/Control_2
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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	# difficult biliary cannulation during therapeutic ERCP # Written informed consent
Key exclusion criteria	# Iability to access to duodenal papilla # Performance status = 4 # Serious other organ failure # Inability to obtain informed consent
Target sample size	20

Research contact person
Name of lead principal investigator	Masayuki Kitano
Organization	Kinki University Faculty of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL	072-366-0221
Email	m-kitano@med.kindai.ac.jp

Public contact
Name of contact person	Masayuki Kitano
Organization	Kinki University Faculty of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL	072-366-0221
Homepage URL
Email	m-kitano@med.kindai.ac.jp

Sponsor
Institute	Study Group for EUS-guided Biliary Drainage
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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	近畿大学医学部附属病院（大阪府）、大阪医科大学附属病院（大阪府）、神戸大学医学部附属病院（兵庫県）、日本赤十字和歌山医療センター（和歌山県）、ベルランド総合病院（大阪府）、川崎医科大学川崎病院（岡山県）、岡山大学医学部附属病院（岡山県）、香川大学医学部附属病院（香川県）、北野病院（大阪府）、佐久総合病院（長野県）

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 23 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 22 Day
Last modified on	2017 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016995