UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050919 |
|---|---|
| Receipt number | R000058040 |
| Scientific Title | Efficacy and safety of cap-assisted endoscopic mucosal resection for superficial duodenal epithelial neoplasia of 10 mm or less |
| Date of disclosure of the study information | 2023/04/25 |
| Last modified on | 2023/04/25 10:10:49 |
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Basic information
Public title
Efficacy and safety of cap-assisted endoscopic mucosal resection for superficial duodenal epithelial neoplasia of 10 mm or less
Acronym
Efficacy and safety of EMRC for SDET of 10 mm or less
Scientific Title
Efficacy and safety of cap-assisted endoscopic mucosal resection for superficial duodenal epithelial neoplasia of 10 mm or less
Scientific Title:Acronym
Efficacy and safety of EMRC for SDET of 10 mm or less
Region
| Japan |
Condition
Condition
superficial duodenal epithelial neoplasia of 10mm or less
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of cap-assisted endoscopic mucosal resection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
R0 resection rate
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
SDETs of 10 mm less that do not have non-lifting signs
Key exclusion criteria
Lesions showing non-lifting by injection, SDTE greater than 11 mm
Target sample size
228
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Kimoto |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-8625
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo
TEL
+81-3-3448-6111
kimoto.yoshiaki@gmail.com
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Kimoto |
Organization
NTT Medical Center Tokyo
Division name
Division of Gastrointestinal Endoscopy
Zip code
141-8625
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo
TEL
+81-3-3448-6111
Homepage URL
kimoto.yoshiaki@gmail.com
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
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
NTT Medical Center Tokyo
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo
Tel
+81-3-3448-6111
kimoto.yoshiaki@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
| 2023 | Year | 04 | Month | 25 | 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
| 2019 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 04 | Month | 25 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058040
