UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051373 |
|---|---|
| Receipt number | R000058613 |
| Scientific Title | A prospective study on the resection depth of underwater cold snare polypectomy (U-CSP) for superficial nonampullary duodenal epithelial tumors |
| Date of disclosure of the study information | 2023/06/19 |
| Last modified on | 2024/02/05 20:22:49 |
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Basic information
Public title
A prospective study on the resection depth of underwater cold snare polypectomy (U-CSP) for superficial nonampullary duodenal epithelial tumors
Acronym
U-CSP study
Scientific Title
A prospective study on the resection depth of underwater cold snare polypectomy (U-CSP) for superficial nonampullary duodenal epithelial tumors
Scientific Title:Acronym
U-CSP study
Region
| Japan |
Condition
Condition
Superficial nonampullary duodenal epithelial tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety including the resection depth of underwater cold snare polypectomy (U-CSP) for superficial nonampullary duodenal epithelial tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resection depth
Key secondary outcomes
Submucosal area in the resected specimen
The proportion of the presence of the muscularis mucosa in the resected specimen
En bloc resection rate
R0 resection rate
Remnant/recurrence rate at 3 months later after procedure
Procedure time
Adverse events rate
Association of the resection depth with disease or treatment factors
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Underwater cold snare polypectomy (U-CSP) group
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
1) Superficial nonampullary duodenal epithelial tumors with a size between 2 mm to 10 mm.
2) Patients who are able to discontinue antithrombotic agents according to the guidelines.
Key exclusion criteria
1) Lesions near the papillae
2) Lesions suspected carcinoma by endoscopic findings (not excluding those diagnosed as intramucosal carcinoma by excisional pathological diagnosis)
3) Residual lesions after endoscopic resection
4) Patients with FAP or Lynch syndrome
5) Patients with hematological abnormality
6) Patients with severe organ failure
7) Patients who have been judged as inappropriate for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Hashiguchi |
Organization
Nagasaki University Hospital
Division name
Department of Endoscopy
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki 852-8501, Japan
TEL
095-819-7489
khashiguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Hashiguchi |
Organization
Nagasaki University Hospital
Division name
Department of Endoscopy
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki 852-8501, Japan
TEL
095-819-7489
Homepage URL
khashiguchi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Nagasaki University Hospital
Address
1-7-1, Sakamoto, Nagasaki 852-8501, Japan
Tel
095-819-7726
rinshou7726@umin.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 | 06 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | 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
Management information
Registered date
| 2023 | Year | 06 | Month | 18 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058613
| 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 |
