UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002572 |
|---|---|
| Receipt number | 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 16:10:51 |
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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
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
midorin@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital, Department of Gastroenterology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003104
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
