UMIN-CTR Clinical Trial

Basic information
Public title	A prospective comparison of biliary cannulation methods in the endoscopic retrograde cholangiopancreatography (ERCP)
Acronym	Biliary cannulation in ERCP
Scientific Title	A prospective comparison of biliary cannulation methods in the endoscopic retrograde cholangiopancreatography (ERCP)
Scientific Title:Acronym	Biliary cannulation in ERCP
Region	Japan Asia(except Japan)

Condition
Condition	Patients who undergo endoscopic retrograde cholangiography or undergo ERCP-related procedures (e.g., bile sampling, biliary duct biopsy, lithectomy, or biliary drainage).
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of present study is to determine which method, contrast-guided cannulation or wire-guided cannulation, and devices, conventional papillotome or new offset-tip papillotome are more useful in achievement of biliary cannulation, and reduction of un-intended access to pancreatic duct on ERCP with the CGC method used at our department and the WGC method used in an overseas hospital (Malaysia University Hospital).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the number of unintended contrast injection into the pancreatic duct and the number of unintended guide wire pass into the pancreatic duct before successful biliary deep cannulation
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	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	CGC methdf cohort with offset-tip papillotome (KD-411Q-0720, Olympus)
Interventions/Control_2	WGC method cohort with offset-tip papillotome (KD-411Q-0720, Olympus).
Interventions/Control_3	WGC method cohort with conventional papillotome (KD-V422M-0730, Olympus).
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)Patients who undergo cholangiography or undergo ERCP-related procedures (e.g., bile sampling, biliary duct biopsy, lithectomy, or biliary drainage). (2)Patients aged 20 years or older. (3)Patients who can give informed consent.
Key exclusion criteria	(1)Patients with a past history of ERCP. (2)Patients with a past history of endoscopic sphincterotomy or balloon dilation. (3)Patients with a past history of abdominal surgery and reconstruction by the Billroth II method or Roux-en-Y method. (4)Patients who require pancreatography. (5)Patients in whom endoscopy is difficult due to serious cardiopulmonary disease or shock state. (6)Pregnant women and possibly pregnant women.
Target sample size	160

Research contact person
Last name of lead principal investigator	1st name Hiroo Middle name Last name Imazu
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Zip code	105-8461
Address	3-25-8 Nishishinbashi, Minato-ku, Tokyo, Japan
TEL	03-3433-1111
Email	himazu21@hotmail.co.jp

Public contact
1st name of contact person	1st name Hiroo Middle name Last name Imazu
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Zip code	105-8461
Address	3-25-8 Nishishinbashi, Minato-ku, Tokyo, Japan
TEL	03-3433-1111
Homepage URL
Email	himazu21@hotmail.co.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	The Jikei University School of Medicine
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	The Jikei University School of Medicine
Address	3-25-8 Nishishinbashi, Minato-ku, Tokyo, Japan
Tel	03-3433-1111
Email	himazu21@hotmail.co.jp

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	2019 Year 05 Month 06 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	160
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	2011 Year 10 Month 03 Day
Date of IRB	2011 Year 10 Month 03 Day
Anticipated trial start date	2012 Year 06 Month 24 Day
Last follow-up date	2019 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 06 Day
Last modified on	2019 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009712