UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041171 |
|---|---|
| Receipt number | R000045723 |
| Scientific Title | Efficacy of underwater endoscopic mucosal resection for sessile serrated lesions. |
| Date of disclosure of the study information | 2020/07/20 |
| Last modified on | 2025/01/24 23:51:49 |
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Basic information
Public title
Efficacy of underwater endoscopic mucosal resection for sessile serrated lesions.
Acronym
CS-UEMR study
Scientific Title
Efficacy of underwater endoscopic mucosal resection for sessile serrated lesions.
Scientific Title:Acronym
CS-UEMR study
Region
| Japan |
Condition
Condition
sessile serrated lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of underwater endoscopic mucosal resection for serrated lesions of 10 to 20mm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complete resection rate
Key secondary outcomes
R0 resection rate
En bloc resection rate
Recurrence rate
Procedure time
difficult-to-resect factors of UEMR
Adverse events
Histology
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
Sessile serrated lesions 10-20mm in size
Sessile serrated lesions confirmed by Narrow band imaging or chromoendoscopy.
Key exclusion criteria
Suspicious of cancer or adenoma
Familial adenomatous polyposis
Inflammatory bowel disease
Infectious disease with systemic therapy indicated
Pregnant or nursing
Impossible to perform UEMR due to antithrombotic drugs
Short prognosis (within one year)
Other inappropriate cases
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Yamasaki |
Organization
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama university
Division name
Department of Misasa Community Medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama
TEL
+81-86-235-7219
yasshifive@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masayasu |
| Middle name | |
| Last name | Ohmori |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama
TEL
+81-86-235-7219
Homepage URL
masayasu.ohmori@gmail.com
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Iwakuni Clinical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
Tel
+81-86-235-7361
ouh-crrb@adm.okayama-u.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
岡山大学病院（岡山県）、岩国医療センター（山口県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the effectiveness of Underwater EMR.
Biopsies will be taken from 4 points around the treatment area of UEMR for evaluation of residuals.
Colonoscopy will be performed 5 to 13 months after UEMR.
Management information
Registered date
| 2020 | Year | 07 | Month | 20 | Day |
Last modified on
| 2025 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045723
