Back to resultsUEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps
Primary Purpose
Colonic Polyps
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Underwater EMR
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Polyps
Eligibility Criteria
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:
- pregnancy,
- 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
Sites / Locations
- Department of Gastroenterology, Haishu No.2 Hospital, Ningbo, China
- Department of Gastroenterology, Ninghai No.2 Hospital, Ningbo, China
- Ningbo first hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Underwater EMR
Traditional EMR
Arm Description
The patients who are randomized to the " Underwater EMR" arm polypectomy with water will be performed under full water emersion without the use of submucosal injection.
The patients who are randomized to the " Traditional EMR" arm polypectomy will be performed with selective saline injection to the layer of tissue underneath the polyp in order to create a "safety cushion" for resection.
Outcomes
Primary Outcome Measures
complete resection rate
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
En bloc resection rate was defined as the entire lesion could be removed in 1 piece instead of piecemeal resection.
Secondary Outcome Measures
Adverse event rate
Including bleeding and perforation , etc.
Procedure time
Time to execute the program
Full Information
NCT ID
NCT03833492
First Posted
February 4, 2019
Last Updated
December 9, 2019
Sponsor
Ningbo No. 1 Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03833492
Brief Title
UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps
Official Title
Efficacy and Safety of Underwater vs. Conventional Endoscopic Mucosal Resection for the Treatment of Diminutive Non-pedunculated Colorectal Polyps：A Multicenter Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ningbo No. 1 Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Underwater EMR
Arm Type
Experimental
Arm Description
The patients who are randomized to the " Underwater EMR" arm polypectomy with water will be performed under full water emersion without the use of submucosal injection.
Arm Title
Traditional EMR
Arm Type
No Intervention
Arm Description
The patients who are randomized to the " Traditional EMR" arm polypectomy will be performed with selective saline injection to the layer of tissue underneath the polyp in order to create a "safety cushion" for resection.
Intervention Type
Behavioral
Intervention Name(s)
Underwater EMR
Intervention Description
Polypectomy is performed under full water emersion without the use of submucosal injection.
Primary Outcome Measure Information:
Title
complete resection rate
Description
complete resection rate is defined as a complete en bloc resection of a lesion with tumor-free lateral and vertical margins.
Time Frame
7 days
Title
En bloc resection rate
Description
En bloc resection rate was defined as the entire lesion could be removed in 1 piece instead of piecemeal resection.
Time Frame
immediately
Secondary Outcome Measure Information:
Title
Adverse event rate
Description
Including bleeding and perforation , etc.
Time Frame
14 days
Title
Procedure time
Description
Time to execute the program
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
pregnancy,
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
Facility Information:
Facility Name
Department of Gastroenterology, Haishu No.2 Hospital, Ningbo, China
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315000
Country
China
Facility Name
Department of Gastroenterology, Ninghai No.2 Hospital, Ningbo, China
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315000
Country
China
Facility Name
Ningbo first hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
32967616
Citation
Zhang Z, Xia Y, Cui H, Yuan X, Wang C, Xie J, Tong Y, Wang W, Xu L. Underwater versus conventional endoscopic mucosal resection for small size non-pedunculated colorectal polyps: a randomized controlled trial : (UEMR vs. CEMR for small size non-pedunculated colorectal polyps). BMC Gastroenterol. 2020 Sep 23;20(1):311. doi: 10.1186/s12876-020-01457-y.
Results Reference
derived
Learn more about this trial
UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps
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