UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060561 |
|---|---|
| Receipt number | R000069229 |
| Scientific Title | A Multicenter Observational Study Evaluating the Usefulness of Gastrointestinal Endoscopy Simulation Training for Pediatricians |
| Date of disclosure of the study information | 2026/02/09 |
| Last modified on | 2026/02/03 11:28:08 |
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Basic information
Public title
A Multicenter Observational Study Evaluating the Usefulness of Gastrointestinal Endoscopy Simulation Training for Pediatricians
Acronym
A Study Assessing the Effectiveness of Endoscopy Simulation Education for Pediatricians
Scientific Title
A Multicenter Observational Study Evaluating the Usefulness of Gastrointestinal Endoscopy Simulation Training for Pediatricians
Scientific Title:Acronym
A Multicenter Observational Study Evaluating the Usefulness of Gastrointestinal Endoscopy Simulation Training for Pediatricians
Region
| Japan |
Condition
Condition
Pediatricians Aiming to Acquire Gastrointestinal Endoscopy Skills
Classification by specialty
| Gastroenterology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Gastrointestinal endoscopy is an essential clinical technique in pediatric gastroenterology, and its importance has been increasing in recent years, partly due to the rising number of patients with inflammatory bowel disease. However, no standardized educational method exists for training pediatricians who perform these procedures, and current training largely depends on the efforts of individual teaching institutions.
To promote pediatric endoscopy practice, the Japan Society of Pediatric Nutrition, Gastroenterology and Hepatology has been organizing the "Pediatric Gastrointestinal Endoscopy Hands-on Seminar" since 2015 and has reported its outcomes.
In this study, we planned a multicenter collaborative observational study to evaluate the impact of this seminar on the dissemination of pediatric gastrointestinal endoscopy in Japan and on the participants' clinical endoscopy practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in participants' gastrointestinal endoscopy practice before and after the hands-on seminar
Changes in participants' attitudes toward gastrointestinal endoscopy practice before and after the hands-on seminar
Key secondary outcomes
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
| Device,equipment | Maneuver |
Interventions/Control_1
Hands-on Training in Gastrointestinal Endoscopic Techniques Using Simulators and Porcine Rectal Tissue
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
| 24 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric healthcare providers participating in the 'Gastrointestinal Endoscopy Hands-on Training for Pediatricians' organized by the Japan Society of Pediatric Nutrition, Gastroenterology and Hepatology
Key exclusion criteria
Participants who did not provide consent to participate
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Iwama |
| Middle name | |
| Last name | Itaru |
Organization
Saitama Children's Medical Center
Division name
Division of Gastroenterology and Hepatology
Zip code
3308778
Address
1-2, Shintoshin, Chuou-ku, Saitama-city
TEL
0486012200
iwama.itaru@saitama-pho.jp
Public contact
Name of contact person
| 1st name | Itaru |
| Middle name | |
| Last name | Iwama |
Organization
Saitama Children's Medical Center
Division name
Division of Gastroenterology and Hepatology
Zip code
3308777
Address
1-2, Shintoshin, Chuou-ku, Saitama-city
TEL
0486012200
Homepage URL
iwama.itaru@saitama-pho.jp
Sponsor or person
Institute
Saitama Children's Medical Center, Division of Gastroenterology and Hepatology
Institute
Department
Personal name
Itaru Iwama
Funding Source
Organization
Saitama Children's Medical Center, Division of Gastroenterology and Hepatology
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
Saitama Children's Medical Center
Address
1-2, Shintoshin, Chuou-ku, Saitama-city
Tel
0486012200
iwama.itaru@saitama-pho.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
| 2026 | Year | 02 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2035 | Year | 03 | 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
| 2026 | Year | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069229
