UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045399 |
|---|---|
| Receipt number | R000051554 |
| Scientific Title | A multi-institutional prospective observational study of the efficacy and safety of under-gel EMR (UGEMR) for superficial duodenal tumor |
| Date of disclosure of the study information | 2021/09/07 |
| Last modified on | 2022/10/01 10:25:30 |
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Basic information
Public title
A multi-institutional prospective observational study of the efficacy and safety of under-gel EMR (UGEMR) for superficial duodenal tumor
Acronym
A multi-institutional prospective observational study of the efficacy and safety of under-gel EMR (UGEMR) for superficial duodenal tumor
Scientific Title
A multi-institutional prospective observational study of the efficacy and safety of under-gel EMR (UGEMR) for superficial duodenal tumor
Scientific Title:Acronym
A multi-institutional prospective observational study of the efficacy and safety of under-gel EMR (UGEMR) for superficial duodenal tumor
Region
| Japan |
Condition
Condition
superficial duodenal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of under-gel EMR (UGEMR) for superficial duodenal tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of R0 resection
Key secondary outcomes
The rate of bleeding
The rate of perforation
The rate of en bloc resection
The rate of recurrence
procedure time
The usage amount of gel
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 superficial duodenal tumors indicated for EMR.
Key exclusion criteria
1) Patients whose lesions extent to papilla of Vater.
2) Patients whose lesions are 20 mm or more.
3) Patients whose lesions are endoscopically suspected of submucosal invasion.
4) Patients with residual or recurrent lesions after endoscopic resection.
5) Patients with familial adenomatous polyposis or Lynch syndrome.
6) Patients with bleeding tendency.
7) Patients who are judged by attending doctors as not suitable for this trial.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nakaoka |
| Middle name | |
| Last name | Michiko |
Organization
Omori Red Cross Hospital
Division name
Gastroenterology
Zip code
143-8527
Address
4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan
TEL
+81-3-3775-3111
michiko_cinnamon@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Nakaoka |
| Middle name | |
| Last name | Michiko |
Organization
Omori Red Cross Hospital
Division name
Gastroenterology
Zip code
143-8527
Address
4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan
TEL
+81-3-3775-3111
Homepage URL
michiko_cinnamon@ybb.ne.jp
Sponsor or person
Institute
Omori Red Cross Hospital, Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
This study do not need financial support
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hiratsuka City Hospital, Chigasaki Municipal Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Omori Red Cross Hospital
Address
4-30-1, Chuo, Ota-Ku, Tokyo, 143-8527, Japan
Tel
+81-3-3775-3111
michiko_cinnamon@ybb.ne.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
大森赤十字病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 07 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the safety and efficacy of under-gel EMR (UGEMR) for superficial duodenal tumor
Management information
Registered date
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2022 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051554
| 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 |
