UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050197 |
|---|---|
| Receipt number | R000057102 |
| Scientific Title | Prospective study of the efficacy and safety of outpatient cold snare polypectomy (CSP) for low atypical duodenal adenoma |
| Date of disclosure of the study information | 2023/01/31 |
| Last modified on | 2023/04/24 19:16:12 |
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Basic information
Public title
Prospective study of the efficacy and safety of outpatient cold snare polypectomy (CSP) for low atypical duodenal adenoma
Acronym
Prospective study of the efficacy and safety of outpatient cold snare polypectomy (CSP) for low atypical duodenal adenoma
Scientific Title
Prospective study of the efficacy and safety of outpatient cold snare polypectomy (CSP) for low atypical duodenal adenoma
Scientific Title:Acronym
Prospective study of the efficacy and safety of outpatient cold snare polypectomy (CSP) for low atypical duodenal adenoma
Region
| Japan |
Condition
Condition
duodenal adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of outpatient cold snare polypectomy (CSP) for low atypical duodenal adenoma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of delayed bleeding
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 with suspected low atypical duodenal adenoma of 12 mm or less by endoscopic findings
Key exclusion criteria
(1)Patients with multiple duodenal tumors associated with familial adenomatous polyposis or hereditary non-polyposis colorectal cancer
(2)Patients who are unable to stop antithrombotic drugs according to the guidelines.
(3) Patients with coagulation dysfunction
(4)Cases with critical organ failure
(5)Other cases judged as inappropriate by the physician
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University, School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Kurato |
| Middle name | |
| Last name | Miyazaki |
Organization
Keio University, School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
k.miyazaki30417@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2023 | Year | 01 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Perform an outpatient cold snare polypectomy (CSP) for duodenal adenoma and observe for any incidentalities such as delayed bleeding.
Management information
Registered date
| 2023 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057102
