UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058757 |
|---|---|
| Receipt number | R000067186 |
| Scientific Title | Efficacy and safety of underwater precutting endoscopic mucosal resection for colorectal polyps 20-30mm in size: a prospective single center study |
| Date of disclosure of the study information | 2025/08/12 |
| Last modified on | 2025/08/11 13:46:41 |
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Basic information
Public title
Efficacy and safety of underwater precutting endoscopic mucosal resection for colorectal polyps 20-30mm in size: a prospective single center study
Acronym
Uper trial
Scientific Title
Efficacy and safety of underwater precutting endoscopic mucosal resection for colorectal polyps 20-30mm in size: a prospective single center study
Scientific Title:Acronym
Uper trial
Region
| Japan |
Condition
Condition
a single clinically diagnosed colorectal polyps measuring 20 to 30 mm in size
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of underwater precutting EMR for colonic polyps 20-30 mm in size
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
All patients provided written informed consent to participate in this study. The colorectal polyps measuring 20 to 30 mm in size is resected by Underwater precutting EMR. All patients were followed up at outpatient visit to check any postoperative adverse events with 28 days after Underwater precutting EMR. The patient was invited for 6 months surveillance colonoscopy. During surveillance colonoscopy, the scar induced by Underwater precutting EMR was identified, the scar was examined for residual using Narrow Band Imaging with magnification. A biopsy of the scar was performed to confirm the histological evaluation.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were as follows:
1. a single clinically diagnosed colorectal polyps measuring 20 to 30 mm in size,
2 age > 20 years;
3 Eastern Cooperative Oncology Group performance status of 0-1.
Key exclusion criteria
The exclusion criteria were as follows: (1) inflammatory bowel disease, (2) familial polyposis syndrome (3) clinically diagnosed invasive cancer (4) recurrent lesion (5) scheduled for surgery for active cancer (6) blood coagulation disorder (7) hemodialysis (8) severe heart disease (9) psychiatric disorder (10) pregnancy.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Takizawa |
Organization
Kanagawa Cancer Center
Division name
Department of Gastroenterology
Zip code
241-8515
Address
2-3-3 Nakao, Asahi-ku, Yokohama, Kanagawa, Japan
TEL
045-520-2222
koh.takizawa@gmail.com
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Shiotsuki |
Organization
Kanagawa Cancer Center
Division name
Department of Gastroenterology
Zip code
241-8515
Address
2-3-3 Nakao, Asahi-ku, Yokohama, Kanagawa, Japan
TEL
045-520-2222
Homepage URL
k.shiotsuki19881014@gmail.com
Sponsor or person
Institute
Kanagawa 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
Kanagawa Cancer Center
Address
2-3-3 Nakao, Asahi-ku, Yokohama, Kanagawa, Japan
Tel
045-520-2222
clinical_trials@kcch.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
| 2025 | Year | 08 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | 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
Management information
Registered date
| 2025 | Year | 08 | Month | 11 | Day |
Last modified on
| 2025 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067186
