UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043487 |
|---|---|
| Receipt number | R000049656 |
| Scientific Title | Single sessional medical check-up program using a forward-viewing radial type echoendoscope for upper gastrointestinal tract and pancreaticobiliary system |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2025/03/07 08:50:55 |
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Basic information
Public title
Single sessional medical check-up program using a forward-viewing radial type echoendoscope for upper gastrointestinal tract and pancreaticobiliary system
Acronym
Single sessional surveillance using a forward-viewing radial type echoendoscope for upper gastrointestinal tract and pancreaticobiliary system
Scientific Title
Single sessional medical check-up program using a forward-viewing radial type echoendoscope for upper gastrointestinal tract and pancreaticobiliary system
Scientific Title:Acronym
Single sessional surveillance using a forward-viewing radial type echoendoscope for upper gastrointestinal tract and pancreaticobiliary system
Region
| Japan |
Condition
Condition
Disease in upper gastrointestinal tract, pancreaticobiliary system.
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
surveillance
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) To investigate a depiction rate and detection rate in forward-viewing EUS compared with EGD.
2) Prevalence of precursor lesions for PDAC in medical check-up.
3) Prognosis in surveillance PDAC and sporadic PDAC
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Forward-viewing radial EUS
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age >=20 years.
2. Scheduled EGD and EUS for surveillance.
3. Obtained written informed consent.
Following criteria is in a surveillance.
4. Patient with risk factors for PDAC.
5. Patient with precursor lesions for PDAC.
Key exclusion criteria
1. Age under 20 years.
2. Altered anatomy.
3. Contraindication for EGD.
4. No written informed consent.
5. Already known PDAC.
6. Others
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | TESSHIN |
| Middle name | |
| Last name | BAN |
Organization
Gamagori City Hospital
Division name
Department of Gastroenterology
Zip code
443-8501
Address
1-1, Mukouda, Hirata, Gamagori, Aichi
TEL
0533-66-2200
venzosan0204@gmail.com
Public contact
Name of contact person
| 1st name | TESSHIN |
| Middle name | |
| Last name | BAN |
Organization
Gamagori City Hospital
Division name
Department of Gastroenterology
Zip code
443-8501
Address
1-1, Mukouda, Hirata, Gamagori, Aichi
TEL
0533-66-2200
Homepage URL
venzosan0204@gmail.com
Sponsor or person
Institute
Gamagori City Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gamagori City Hospital
Address
1-1, Mukouda, Hirata, Gamagori, Aichi
Tel
0533-66-2200
nakagami-norihide@city.gamagori.lg.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 | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 01 | Day |
Last modified on
| 2025 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049656
