UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036657 |
|---|---|
| Receipt number | 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 13:18:46 |
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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
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
himazu21@hotmail.co.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009712
