UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047391 |
|---|---|
| Receipt number | R000054054 |
| Scientific Title | A single-blind randomized controlled trial to evaluate the effectiveness of an educational program using a novel ERCP dry simulator |
| Date of disclosure of the study information | 2022/04/25 |
| Last modified on | 2025/05/11 00:28:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A single-blind randomized controlled trial to evaluate the effectiveness of an educational program using a novel ERCP dry simulator
Acronym
A single-blind randomized controlled trial to evaluate the effectiveness of an educational program using a novel ERCP dry simulator
Scientific Title
A single-blind randomized controlled trial to evaluate the effectiveness of an educational program using a novel ERCP dry simulator
Scientific Title:Acronym
A single-blind randomized controlled trial to evaluate the effectiveness of an educational program using a novel ERCP dry simulator
Region
| Japan |
Condition
Condition
Gastroenterologists and resident doctors performing endoscopic retrograde cholangiopancreatography and endoscopic sphincterotomy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the learning effects of educational programs using the novel ERCP model
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Absolute/ relative change in the objective assessment of ERCP skills by blinded experts at one-month after enrollment between the two groups with and without educational intervention. We use Bethesda ERCP Skill Assessment tool(BESATv-4). Absolute/ relative change will be compared both in each component.
Key secondary outcomes
Absolute/ relative change in learners' own subjective evaluations of ERCP, including knowledge and confidence, at one-month after enrollment between the two groups with and without educational intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Education on endoscopic retrograde cholangiopancreatography and endoscopic sphincterotomy using a novel simulator
Interventions/Control_2
No education
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 does not consent to the study
Target sample size
14
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
The Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-717-8007
med-kenkyo@grp.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
| 2022 | Year | 04 | Month | 25 | 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 | 11 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 15 | 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: A total of 9 participants have agreed to participate and educational intervention is being conducted according to the protocol. Recruitment of participants and the educational intervention study are ongoing.
May 11, 2025: A total of 14 participants have consented to participate in the educational intervention according to the protocol. The results are being analyzed and a paper is currently being written.
Management information
Registered date
| 2022 | Year | 04 | Month | 04 | 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=R000054054
