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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002572
Receipt No. R000003104
Scientific Title A prospective randomized controlled multicenter trial of catheter and papillotome: effect on selective cannulation of the common bile duct in endoscopic retrograde cholangiopancreatography
Date of disclosure of the study information 2009/10/01
Last modified on 2012/05/01

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Basic information
Public title A prospective randomized controlled multicenter trial of catheter and papillotome: effect on selective cannulation of the common bile duct in endoscopic retrograde cholangiopancreatography
Acronym Japan Bile duct cannulation Study (Japan BDCS)
Scientific Title A prospective randomized controlled multicenter trial of catheter and papillotome: effect on selective cannulation of the common bile duct in endoscopic retrograde cholangiopancreatography
Scientific Title:Acronym Japan Bile duct cannulation Study (Japan BDCS)
Region
Japan

Condition
Condition Pancreaticobiliary disease
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The primary success rate of selective cannulation of common bile duct between ERCP catheter and papillotome with/without guidewire for ERCP
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The main outcome measurement was successful or failed selective cannulation of the common bile duct with wire-guided catheter or hydrophilic guidewire within a period of 10 minutes.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 ERCP catheter
Interventions/Control_2 Papillotome
Interventions/Control_3 Contrast medium
Interventions/Control_4 guidewire
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 The study group included patients who required cholangiography and an intact papilla of Vater.
Patients who are planned ERCP.
Patients who fully understand and are willing to give a written informed consent about participation.
Key exclusion criteria Performance status of 4 (Completely disabled. Cannot carry out any selfcare. Totally confined to bed or chair); severe heart disease; severe lung disease; age 20 years younger; pregnant and breast-feeding women or women suspected of being pregnant; women are not willing to avoid pregnancy during the duration of study; history of previous endoscopic sphincterotomy; previous endoscopic balloon dilatation; ampullary neoplasm and infiltration of the papillary area by pancreatic cancer; acute pancreatitis; chronic pancreatitis with an acute exacerbation; impacted common bile duct stone; Billroth II gastrectomy; Roux-en-Y reconstruction; separate orifices of the common bile duct and pancreatic duct on the papilla; pancreaticobiliary maljunction; biliary cannulation using with Rendezvous method; contrast medium allergy; or refusal to provide informed consent.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi KAWAKAMI
Organization Hokkaido University Hospital
Division name Department of Gastroenterology
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo 060-8638, Japan
TEL 011-716-1161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Midori NISHIOKA
Organization Hokkaido University Hospital
Division name Clinical research head office
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo 060-8638, Japan
TEL 011-716-1161
Homepage URL
Email midorin@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital, Department of Gastroenterology
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Completed
Date of protocol fixation
2009 Year 07 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
2010 Year 09 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 01 Day
Last modified on
2012 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003104

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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