UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056830 |
|---|---|
| Receipt number | R000064912 |
| Scientific Title | Specimen suction retrieval success rate of conventional endoscopic mucosal resection (CEMR) VS under water endoscopic mucosal resection (UEMR) : Randomized controlled trial |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/01/27 11:12:27 |
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Basic information
Public title
Specimen suction retrieval success rate of conventional endoscopic mucosal resection (CEMR) VS under water endoscopic mucosal resection (UEMR) : Randomized controlled trial
Acronym
Specimen suction retrieval success rate of CEMR VS UEMR: RCT
Scientific Title
Specimen suction retrieval success rate of conventional endoscopic mucosal resection (CEMR) VS under water endoscopic mucosal resection (UEMR) : Randomized controlled trial
Scientific Title:Acronym
Specimen suction retrieval success rate of CEMR VS UEMR: RCT
Region
| Japan |
Condition
Condition
Colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The success rate of suction retrieval of specimens after endoscopic resection is compared between the Under water Endoscopic Mucosal Resection (UEMR) and Conventional Endoscopic Mucosal Resection (CEMR) methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The success rate of suction retrieval of specimens after endoscopic resection. Successful aspiration is defined as "a specimen that has no macroscopic damage and can tolerate pathological evaluation" and "a specimen that can be suctioned from the suction port of the endoscope".
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
UEMR
Interventions/Control_2
CEMR
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among patients scheduled to be treated for colorectal polyps by endoscopic resection at our hospital, patients who meet the following inclusion criteria and do not meet the exclusion criteria will be registered and included in the study.
1) Patients with colorectal polyps measuring 6 mm or more but less than 15 mm
2) Tumorous or non-tumorous polyps are both acceptable
3) Patients who wish to be treated by endoscopic resection of polyps
4) Patients are received a written explanation of the contents of the study and has consented to the contents.
Key exclusion criteria
1) Patients with gastrointestinal bleeding
2) Patients with serious comorbidities
3) Patients with inflammatory bowel disease
4) Patients with a history of colectomy (excluding appendectomy)
5) Patients with a score of 0 or 1 in at least one of the four segments (right colon, transverse colon, and left colon) as assessed using the Boston Bowel Preparation Scale (0-3)
6) Cases where colonoscopy insertion is difficult
7) Patients with gastrointestinal polyposis (both genetic and non-genetic)
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | TAKAYUKI |
| Middle name | |
| Last name | NAGAHASHI |
Organization
Fukushima Medical University
Division name
Department of Minimally Invasive Surgical and Medical Oncology
Zip code
960-1295
Address
1, hikarigaoka, Fukushima, Japan
TEL
0245471111
naga125@fmu.ac.jp
Public contact
Name of contact person
| 1st name | TAKAYUKI |
| Middle name | |
| Last name | NAGAHASHI |
Organization
Fukushima Medical University
Division name
Department of Minimally Invasive Surgical and Medical Oncology
Zip code
960-1295
Address
1, hikarigaoka, Fukushima, Japan
TEL
0245471111
Homepage URL
naga125@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
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
Fukushima Medical University
Address
1, hikarigaoka, Fukushima, Japan
Tel
0245471111
naga125@fmu.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
一般財団法人脳神経疾患研究所附属総合南東北病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | 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
| 2025 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 01 | Month | 27 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064912
