UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051918 |
|---|---|
| Receipt number | R000053836 |
| Scientific Title | validation study of an endoscopic diagnosis algorithm for Major papilla using magnified endoscopic examination with image-enhanced endoscopy |
| Date of disclosure of the study information | 2023/08/20 |
| Last modified on | 2025/02/14 18:44:47 |
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Basic information
Public title
validation study of an endoscopic diagnosis algorithm for Major papilla using magnified endoscopic examination with image-enhanced endoscopy
Acronym
VEP study
Scientific Title
validation study of an endoscopic diagnosis algorithm for Major papilla using magnified endoscopic examination with image-enhanced endoscopy
Scientific Title:Acronym
VEP study
Region
| Japan |
Condition
Condition
Major papilla tumor
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
validate endoscopic diagnosis algorithm for Major papilla using magnified endoscopic examination with image-enhanced endoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
diagnostic ability of magnified endoscopic examination with image-enhanced endoscopy
Key secondary outcomes
success rate of magnified endoscopic examination of major pappilla, tumor and non-tumor ratio of endoscopic classification, pathological malignant ratio, time taken of endoscopic examination, the success rate of observing major papilla
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a
Key exclusion criteria
a
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Kawasaki |
Organization
Keio University
Division name
diagnosis and therapeutic endoscopic center
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
s.kawasaki@keio.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Kawasaki |
Organization
Keio University
Division name
Endoscopic diagnosis and therapeutic center
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
s.kawasaki@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
TOKYO MEDICAL CENTER
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
s.kawasaki@keio.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)、東京医療センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 20 | 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
| 2023 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 10 | 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
multi center cross sectional study
Management information
Registered date
| 2023 | Year | 08 | Month | 15 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053836
