UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004698 |
|---|---|
| Receipt number | R000005593 |
| Scientific Title | Comparison between pulse fluoroscopy and conventional fluoroscopy in the ERCP related procedure |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2016/11/14 21:44:35 |
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Basic information
Public title
Comparison between pulse fluoroscopy and conventional fluoroscopy in the ERCP related procedure
Acronym
Usefulness of pulse fluoroscopy for ERCP related procedure
Scientific Title
Comparison between pulse fluoroscopy and conventional fluoroscopy in the ERCP related procedure
Scientific Title:Acronym
Usefulness of pulse fluoroscopy for ERCP related procedure
Region
| Japan |
Condition
Condition
patients with pancreatobiliary disorders that have indication of ERCP related procedures
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the radiation dose of continuous fluoroscopy conditions with pulse fluoroscopy of 15 per second during ERCP related procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is comparison the quality of image of pulse fluoroscopy with that of continuous fluoroscopy that affects clinical practice.
Key secondary outcomes
The secondary endpoint is comparison of radiation dose between two groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
pulse fluoroscopy group
Interventions/Control_2
continuous (conventional) fluoroscopy group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients are more than 19 years of age, suspected pancreatobiliary disorders that have indication of ERCP related procedures, with written informed consent
Key exclusion criteria
The patients are not approved for ERCP related procedure because of general condition.
Target sample size
92
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Shimizu |
Organization
Toki Municipal General Hospital
Division name
Depertment of Gastroenterology
Zip code
Address
703 Tokiguchi Tokitsu-cho Toki city Gifu prefecture Japan
TEL
0572-55-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Kawashima |
Organization
Nagoya University Graduate school of Medicine
Division name
Depertment of Gastroenterology
Zip code
Address
65 Tsuruma-cho, showa-ku, Nagoya, 466-8550 Japan
TEL
+81-52-744-2602
Homepage URL
h-kawa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Toki Municipal General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
土岐市立総合病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 09 | Day |
Last modified on
| 2016 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005593
