NCT03833492CompletedNot Applicable
Efficacy and Safety of Underwater vs. Conventional Endoscopic Mucosal Resection for the Treatment of Diminutive Non-pedunculated Colorectal Polyps：A Multicenter Randomized Clinical Trial
Ningbo No. 1 Hospital3 sites in 1 country130 target enrollmentStarted: May 1, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 130
- Locations
- 3
- Primary Endpoint
- complete resection rate
Study Overview
Brief Summary
This clinical trial is being conducted to compare the efficacy and safety of two standard methods of polypectomy，Conventional Endoscopic Mucosal Resection（EMR）and Underwater Endoscopic Mucosal Resection（UEMR），for small colorectal polyps.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients age between 18-75 years old with non-pedunculated colonic polyps (measuring between 4 and 9mm), who willing to participate in this study.
Exclusion Criteria
- •inflammatory bowel disease,
- •familial polyposis
- •the use of anticoagulant therapy or antiplatelet therapy
- •the absence of informed patient consent.
- •Polyps showing signs of deep submucosal invasion
Outcomes
Primary Outcomes
complete resection rate
Time Frame: 7 days
complete resection rate is defined as a complete en bloc resection of a lesion with tumor-free lateral and vertical margins.
En bloc resection rate
Time Frame: immediately
En bloc resection rate was defined as the entire lesion could be removed in 1 piece instead of piecemeal resection.
Secondary Outcomes
- Adverse event rate(14 days)
- Procedure time(24 hours)
Investigators
Study Sites (3)
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