UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Wire-guided cannulation: J shaped-tip or straight-tip guidewire
Title of the study (Brief title)	WGC: J-shaped or straight tip guidewire
Region	Japan

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

Objectives
Narrative objectives1	To assess efficacy of J-shaped tip guidewire for selective biliary cannulation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Successful biliary cannulation
Key secondary outcomes	Adverse event

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Biliary cannulation attempt with J-shaped tip GW for 10 min. If failed, biliary cannulation attempt with straight tip GW for another 10 min.
Interventions/Control_2	Biliary cannulation attempt with straight tip GW for 10 min. If failed, biliary cannulation attempt with J-shaped tip GW for another 10 min.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Naive papilla (2)Requirement for biliary cannulation (3)Written informed consent
Key exclusion criteria	(1)Impossible endoscopic intubation (2)Performance status 4 (3)After papilloplasty (4)Surgically-altered anatomy (5)Severe comorbidities in other organ (6)No receipt of informed consent (7)Patients considered unsuitable for enrollment
Target sample size	160

Research contact person
Name of lead principal investigator	Iruru Maetani
Organization	Toho University Ohashi Medical Center
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine
Address	2-17-6 Ohashi Meguro-ku Tokyo
TEL	03-3468-1251
Email	maetani-gi@umin.ac.jp

Public contact
Name of contact person	Iruru Maetani
Organization	Toho University Ohashi Medical Center
Division name	Division of Gastroenterology an
Address	2-17-6 Ohashi Meguro-ku Tokyo
TEL	03-3468-1251
Homepage URL
Email	maetani-gi@umin.ac.jp

Sponsor
Institute	Toho University Ohashi Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2013 Year 10 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 09 Day
Anticipated trial start date	2013 Year 10 Month 14 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 07 Day
Last modified on	2018 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013990