UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055227 |
|---|---|
| Receipt number | R000063098 |
| Scientific Title | Dose Reduction in Endoscopic Retrograde Cholangiopancreatography (ERCP) Using a Novel Fluoroscopic Protocol |
| Date of disclosure of the study information | 2024/08/13 |
| Last modified on | 2025/08/13 17:53:25 |
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Basic information
Public title
Dose Reduction in Endoscopic Retrograde Cholangiopancreatography (ERCP) Using a Novel Fluoroscopic Protocol
Acronym
Dose Reduction in Endoscopic Retrograde Cholangiopancreatography (ERCP) Using a Novel Fluoroscopic Protocol
Scientific Title
Dose Reduction in Endoscopic Retrograde Cholangiopancreatography (ERCP) Using a Novel Fluoroscopic Protocol
Scientific Title:Acronym
Dose Reduction in Endoscopic Retrograde Cholangiopancreatography (ERCP) Using a Novel Fluoroscopic Protocol
Region
| Japan |
Condition
Condition
common bile duct stone
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Keio University Hospital has been using the Ultimax-i fluoroscopy system (Canon, Tochigi, Japan) for ERCP (Endoscopic retrograde cholangiopancreatography) examinations since 2020. Recently, a new fluoroscopic protocol called "Contrast-Enhanced mode (CE mode)" has been added to the Ultimax-i. The CE mode increases the contrast and brightens the background to obtain high visibility even at low doses. The protocol can be easily switched from standard to CE mode by clicking a button on the operation console. We have already conducted a basic study using phantom for actual ERCP examinations and reported (unpublished) that some CE modes have superior dynamic spatial resolution in spite of lower dose compared to conventional modes. In actual clinical practice, we have switched to the CE mode in cases with low fluoroscopic visibility. However, no study has demonstrated the usefulness of this mode in actual ERCP examinations. In this study, we investigate the dose reduction by using this new fluoroscopic protocol. The purpose of this study is to evaluate a new fluoroscopic protocol for reducing patient and operator exposure in ERCP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Radiation dose in ERCP
Key secondary outcomes
Clinical success rate of treatment and exposure time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Groups using conventional standard protocol (7.5 fps, Mid)
Interventions/Control_2
Groups using new CE protocol (3.75fps, Low)
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
The subjects of this study are patients over 18 years old who will undergo the following ERCP treatments at Keio University Hospital and who have given their consent.
1) Patients undergoing initial stone removal for common bile duct stones
2) Patients who undergo first stone removal after bile duct stenting for acute cholangitis
Key exclusion criteria
1) Those under 18 years of age
2) BMI over 30
3) Pregnant or suspected pregnancy
4) If the patient is unable to give consent
5) If it is difficult to obtain consent from the subject of the research due to a disturbance in consciousness, cognitive dysfunction, or mental retardation at the time of obtaining consent
6) Other cases in which the person in charge deems it inappropriate for the subject to participate in this research
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Kanai |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-5363-3790
takaokihayakawa@keio.jp
Public contact
Name of contact person
| 1st name | Takaoki |
| Middle name | |
| Last name | Hayakawa |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-5363-3790
Homepage URL
takaokihayakawa@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Keio University School of Medicine Ethics Committee
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
Tel
+81-3-5363-3790
med-rinri-jimu@adst.keio.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
慶應義塾大学病院 (東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2026 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063098
