UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043144 |
|---|---|
| Receipt number | R000049235 |
| Scientific Title | Safety and Efficacy of Underwater Endoscopic Mucosal Resection for 10-20 mm Colorectal Serrated Lesions |
| Date of disclosure of the study information | 2021/01/31 |
| Last modified on | 2023/01/29 10:28:46 |
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Basic information
Public title
Research of endoscopic resection for Colorectal Serrated Lesions
Acronym
SEA CLEAR study
Scientific Title
Safety and Efficacy of Underwater Endoscopic Mucosal Resection for 10-20 mm Colorectal Serrated Lesions
Scientific Title:Acronym
SEA CLEAR study
Region
| Japan |
Condition
Condition
Colorectal serrated lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of underwater endoscopic mucosal resection for 10-20mm colorectal serrated lesions
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of histological complete resection
Key secondary outcomes
Rate of R0 resection
Rate of immediate bleeding and perforation
Rate of postbleeding
Rate of residual tumor
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
1. Consider candidate for UEMR
2. Endoscopically diagnosed 10-20mm colorectal serrated lesions
3. 20 years old and more
4. Written informed consent
Key exclusion criteria
1. Lesions with area that cant be diagnosed as JNET Type1
2. Synchronous colorectal cancer requiring surgery
3. Residual lesions
4. Inflammatory bowel disease
5. Hematologic disease
6. Pregnancy
7. Hemodialysis
8. Patients that cant discontinue antithrombotic drug
9. Others
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Imai |
Organization
Shizuoka cancer center
Division name
Devision of Endoscopy
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
ke.imai@scchr.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Imai |
Organization
Shizuoka cancer center
Division name
Devision of Endoscopy
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
ke.imai@scchr.jp
Sponsor or person
Institute
Shizuoka cancer center
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
Shizuoka cancer center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel
055-989-5222
tansaku_office@scchr.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
| 2021 | 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
62
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
| 2021 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
We plan to perform surveillance colonoscopy 1 year after UEMR.
Management information
Registered date
| 2021 | Year | 01 | Month | 27 | Day |
Last modified on
| 2023 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049235
| 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 |
