UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044223 |
|---|---|
| Receipt number | R000050418 |
| Scientific Title | A multicenter, prospective, observational study evaluation the learning effect of an e-learning system-based teaching method on biliary cannulation for native papilla in ERCP |
| Date of disclosure of the study information | 2021/05/31 |
| Last modified on | 2025/11/20 13:37:42 |
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Basic information
Public title
A multicenter, prospective, observational study evaluation the learning effect of an e-learning system-based teaching method on biliary cannulation for native papilla in ERCP
Acronym
A study evaluation the learning effect of an e-learning system-based teaching method on biliary cannulation
Scientific Title
A multicenter, prospective, observational study evaluation the learning effect of an e-learning system-based teaching method on biliary cannulation for native papilla in ERCP
Scientific Title:Acronym
A study evaluation the learning effect of an e-learning system-based teaching method on biliary cannulation
Region
| Japan |
Condition
Condition
Biliary tract disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the improvement of biliary cannulation in ERCP by using an e-learning system-based teaching method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decrease rate of difficult cannulation
Key secondary outcomes
biliary cannulation success rate, biliary cannulation time, adverse events
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Education using e-learning system
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Endoscopists with ERCP experience for >=2 years and <=7 years.
2) Endoscopists planning to work at same hospital for a half year.
Key exclusion criteria
1) Internet is not available
2) Inability to provide sufficient information to the research office
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Yamada |
Organization
Iwata city hospital
Division name
Division of Gastroenterology
Zip code
4388550
Address
512-3, Ookubo, Iwata-shi
TEL
0538385000
takanoriymd@gmail.com
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Kaneko |
Organization
Iwata city hospital
Division name
Division of Gastroenterology
Zip code
4388550
Address
512-3, Ookubo, Iwata-shi
TEL
0538385000
Homepage URL
meganerock10@gmail.com
Sponsor or person
Institute
Iwata city hospital
Institute
Department
Personal name
Funding Source
Organization
Iwata city hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seirei hamamatsu general hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwata city hospital
Address
512-3, Ookubo, Iwata-shi
Tel
0538385000
meganerock10@gmail.com
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 | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1002/deo2.70068
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/deo2.70068
Number of participants that the trial has enrolled
12
Results
The overall and per-trainee analyses showed no significant differences in the difficult biliary cannulation rate, trainee failure rate, and adverse event incidence before and after e-learning. However, the overall analysis showed a significant increase in comprehension scores after e-learning (median 4 vs. 5, p < 0.01) and the per-trainee analysis revealed that the rate of comprehension score >=5 increased significantly after e-learning (p=0.02).
Results date posted
| 2025 | Year | 11 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eleven endoscopy trainees participated in this study. The median age of the trainees was 29 years (range 29-35), comprising 11 males and one female trainee. Five trainees had 2-3 years of ERCP experience, four had 3-4 years, one had 4-5 years, and one had 5 years of experience.
Participant flow
A total of 220 patients with native papillae underwent biliary cannulation by trainees before and after e-learning (110 patients before e-learning, and 110 patients after).
Adverse events
N/A
Outcome measures
Eleven trainees participated in the e-learning program. The overall and per-trainee analyses showed no significant differences in the difficult biliary cannulation rate, trainee failure rate, and adverse event incidence before and after e-learning. However, the overall analysis showed a significant increase in comprehension scores after e-learning (median 4 vs. 5, p < 0.01) and the per-trainee analysis revealed that the rate of comprehension score >=5 increased significantly after e-learning (p = 0.02). Comprehension score <5 (odds ratio: 4.31, p < 0.01) and endoscopic retrograde cholangiopancreatography experience <3 years (odds ratio: 2.15, p = 0.01) were independent risk factors for difficult biliary cannulation. Additionally, the difficult biliary cannulation incidence showed a negative correlation with the comprehension score (p < 0.01).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 16 | Day |
Last modified on
| 2025 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050418
