UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054135 |
|---|---|
| Receipt number | R000061814 |
| Scientific Title | Efficacy of endoscopic resection for superficial non-ampullary duodenal epithelial tumor |
| Date of disclosure of the study information | 2024/04/15 |
| Last modified on | 2024/04/12 15:48:54 |
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Basic information
Public title
Efficacy of endoscopic resection for superficial non-ampullary duodenal epithelial tumor
Acronym
Efficacy of endoscopic resection for duodenal tumors
Scientific Title
Efficacy of endoscopic resection for superficial non-ampullary duodenal epithelial tumor
Scientific Title:Acronym
Efficacy of endoscopic resection for superficial non-ampullary duodenal epithelial tumor
Region
| Japan |
Condition
Condition
uperficial non-ampullary duodenal epithelial tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the endoscopic treatment for SNADET
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate resection diamater,resection time,R0 rate,and post treatment course.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who performed endoscopic treatment for SNADET.
Key exclusion criteria
patients who refuses to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Sawada |
Organization
Hirosaki University Hospital
Division name
Department of Gastroenterology,Hematology and Immunology
Zip code
036-8562
Address
53 Hon-cho,Hirosaki
TEL
0172335111
sawada-y@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Sawada |
Organization
Hirosaki University Hospital
Division name
Department of Gastroenterology,Hematology and Immunology
Zip code
036-8562
Address
53 Hon-cho,Hirosaki
TEL
0172335111
Homepage URL
sawada-y@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Hospital
Institute
Department
Personal name
Y
Funding Source
Organization
Hirosaki University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University Hospital
Address
53 Hon-cho,Hirosaki
Tel
0172335111
sawada-y@hirosaki-u.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
| 2024 | Year | 04 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
100 cases who performed endoscopic treatment (EMR,UEMR,and ESD) for SNADET.
From electronic medical records, we collected medical information;patients chalactaristics,location,resection diamater,resection time,R0 rate,and post treatment course.
Management information
Registered date
| 2024 | Year | 04 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061814
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
