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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036657
Receipt No. R000009712
Scientific Title A prospective comparison of biliary cannulation methods in the endoscopic retrograde cholangiopancreatography (ERCP)
Date of disclosure of the study information 2019/05/06
Last modified on 2019/05/06

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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
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
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

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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