UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054990 |
|---|---|
| Receipt number | R000062829 |
| Scientific Title | Outcomes of large SNADET after ESD |
| Date of disclosure of the study information | 2024/07/17 |
| Last modified on | 2024/07/17 10:31:09 |
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Basic information
Public title
Clinical outcomes after endoscopic submucosal dissection of superficial non-ampullary duodenal epithelial tumors larger than 40 mm.
Acronym
Outcomes of large SNADET after ESD
Scientific Title
Outcomes of large SNADET after ESD
Scientific Title:Acronym
Outcomes of large SNADET after ESD
Region
| Japan |
Condition
Condition
superficial non-ampullary duodenal epithelial tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the long-term outcomes after the endoscopic treatment of superficial non-ampullary duodenal epithelial tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival rate (OS), Disease specific survival rate (DSS), local recurrence rate
Key secondary outcomes
Risk factors of the metastatic and/or local recurrence
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 with SNADET larger than 40 mm.
Key exclusion criteria
1. Patients with severe complications who were unable to tolerate surgery (e.g., severe heart/kidney/lung/liver disease)
2. Patients in disagreement with informed consent
3. Others
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Sakai |
Organization
NTT Medical Center Tokyo
Division name
Gastrointestinal endoscopy
Zip code
141-8625
Address
5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL
03-3448-6111
eiji-not_found@goo.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Sakai |
Organization
NTT Medical Center Tokyo
Division name
Gastrointestinal endoscopy
Zip code
247
Address
5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL
03-3448-6111
Homepage URL
eiji-not_found@goo.jp
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
NTT Medical Center Tokyo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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 141-8625, Japan
Tel
03-3448-6111
eiji-not_found@goo.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 | 07 | Month | 17 | 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
56
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 07 | Month | 17 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062829
