UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014846 |
|---|---|
| Receipt number | R000017252 |
| Scientific Title | Evaluation of early pre-cutting using cannulating sphincterotome for selective bile duct cannulation |
| Date of disclosure of the study information | 2014/08/12 |
| Last modified on | 2015/10/25 13:19:07 |
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Basic information
Public title
Evaluation of early pre-cutting using cannulating sphincterotome for selective bile duct cannulation
Acronym
ATOMIC trial
Scientific Title
Evaluation of early pre-cutting using cannulating sphincterotome for selective bile duct cannulation
Scientific Title:Acronym
ATOMIC trial
Region
| Japan |
Condition
Condition
biliary tract disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the selective biliary deep cannulation (SBDC) using cannulating sphincterotome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
SBDC rate
Adverse event (pancreatitis, perforation, bleeding)
procedure duration time (for SBDC, for EST)
Key secondary outcomes
Unsuccessful factors for SBDC and factors for adverse event for cannulation using cannulating sphincterotome
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Cannulating sphincterotome
Interventions/Control_2
The algorithm for SBDC used before
Interventions/Control_3
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Naive pappila
Candidate for EST
No coaglopathy
No surgical altered upper GI tract except for B1
Obtained written IC
Key exclusion criteria
No naive papilla
Caglopathy
Surgical altered upper GI tract
Minor
No written IC
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TESSHIN BAN |
Organization
Nagoya Daini Red Cross Hospital
Division name
Dept. of Gastroentelorogy and Hepatology
Zip code
Address
2-9 Myokencho, showa-ku, Nagoya, Japan
TEL
052-832-1121
venzo@nagoya2.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TESSHIN BAN |
Organization
Nagoya Daini Red Cross Hospital
Division name
Dept. of Gastroentelorogy and Hepatology
Zip code
Address
2-9 Myokencho, showa-ku, Nagoya, Japan
TEL
052-832-1121
Homepage URL
venzo@nagoya2.jrc.or.jp
Sponsor or person
Institute
Nagoya Daini Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
NO funding souece
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
| 2014 | Year | 08 | Month | 12 | 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
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
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2017 | Year | 06 | 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
| 2014 | Year | 08 | Month | 12 | Day |
Last modified on
| 2015 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017252
| Research Plan | |
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| 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 |
