UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044823 |
|---|---|
| Receipt number | R000051195 |
| Scientific Title | Educational intervention study for establishing a safe learning method with a novel duodenal simulator model |
| Date of disclosure of the study information | 2021/07/10 |
| Last modified on | 2025/05/11 00:26:45 |
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Basic information
Public title
Educational intervention study for establishing a safe learning method with a novel duodenal simulator model
Acronym
Educational intervention study for establishing a safe learning method with a novel duodenal simulator model
Scientific Title
Educational intervention study for establishing a safe learning method with a novel duodenal simulator model
Scientific Title:Acronym
Educational intervention study for establishing a safe learning method with a novel duodenal simulator model
Region
| Japan |
Condition
Condition
Gastroenterologists and resident doctors performing endoscopic retrograde cholangiopancreatography and endoscopic sphincterotomy
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of hands-on training for trainees with a novel duodenal simulator model
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of Visual Analog Scale score between before and after simulator training for trainees
Key secondary outcomes
To clarify factors related to complete duodenal papillotomy and lithotripsy: such as number of years of experience, number of cases experienced, and appropriate use of each device in each situation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Gastroenterologists and resident doctors performing endoscopic retrograde cholangiopancreatography and endoscopic sphincterotomy
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Gastroenterologists and resident doctors performing endoscopic retrograde cholangiopancreatography and endoscopic sphincterotomy
Key exclusion criteria
a person cannot consent to the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kanno |
Organization
Tohoku University Hospital
Division name
Department of Education and Support for Regional Medicine
Zip code
980-8575
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-7000
kanno.takeshi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Hatayama |
Organization
Tohoku University Hospital
Division name
Department of Gastroenterology
Zip code
980-8575
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-7171
Homepage URL
yutaka.hatayama.e4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Endoscopic Medical Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Tohoku University Hospital
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
Tel
022-717-7000
rinri-esct@proj.med.tohoku.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
| 2021 | Year | 07 | Month | 10 | 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
| 2021 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
January 11, 2023: Follow-up is underway with educational intervention through a model practice for a total of 22 participants. The study is continuing to recruit additional participants.
May 11, 2025: Educational intervention through the model practice has been completed for a total of 30 participants. The results are being analyzed and a paper is currently being written.
Management information
Registered date
| 2021 | Year | 07 | Month | 10 | Day |
Last modified on
| 2025 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051195
