UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054790 |
|---|---|
| Receipt number | R000062512 |
| Scientific Title | Low frame rate vs standard frame rate fluoroscopy to reduce radiation exposure in balloon-assisted ERCP: A Multi-center Prospective Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/03/28 12:02:40 |
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Basic information
Public title
Low frame rate vs standard frame rate fluoroscopy to reduce radiation exposure in balloon-assisted ERCP: A Multi-center Prospective Randomized Controlled Trial
Acronym
Low frame rate vs standard frame rate fluoroscopy to reduce radiation exposure in balloon-assisted ERCP: A Multi-center Prospective Randomized Controlled Trial
Scientific Title
Low frame rate vs standard frame rate fluoroscopy to reduce radiation exposure in balloon-assisted ERCP: A Multi-center Prospective Randomized Controlled Trial
Scientific Title:Acronym
Low frame rate vs standard frame rate fluoroscopy to reduce radiation exposure in balloon-assisted ERCP: A Multi-center Prospective Randomized Controlled Trial
Region
| Japan |
Condition
Condition
patients with surgically altered anatomy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reduce radiation exposure during balloon enteroscopy-assisted ERCP in patients with surgically altered anatomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endoscope insertion time
Key secondary outcomes
Success rate of endoscope insertion
Air karma value
Incidence of complications
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group of low frame rate
Interventions/Control_2
Group of regular frame rate
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with altered upper GI anatomy and have or suspected to have biliary pancreatic disease
Key exclusion criteria
Patients who cannot undergo endoscopy
Pregnant patients
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Okayama University Hospital
Division name
Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL
086-235-7219
pa793ygx@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kajitani |
Organization
Okayama University Hospital
Division name
Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL
086-235-7219
Homepage URL
p1m21r62@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University 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
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
Tel
086-235-7219
p1m21r62@okayama-u.ac.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
| 2024 | Year | 07 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062512
