Back to resultsCold Snare Polypectomy Versus. Endoscopic Mucosal Resection
Primary Purpose
Colonic Polyp
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EMR
CSP
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Polyp focused on measuring Colonic polyp
Eligibility Criteria
Inclusion Criteria:
- All those over the age of 20 years who agree informed consent and who have at least one polyp of eligible size (6-10 mm)
Exclusion Criteria:
- (1) patients taking anticoagulant therapy during the past 1 week of the procedure, (2) known coagulopathy, (3) history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel diseases or significant infectious disease, (4) American Society of Anesthesiology class III or more, and (5) pedunculated polyps and polyps with malignant feature.
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cold snare polypectomy
Endoscopic mucosal resection
Arm Description
CSP will be performed by closing the snare loop after positioning the open snare at the point of lesion.
EMR will be performed in the way of drawing the lesion into the loop of the snare and resecting followed by saline injection to the its margin.
Outcomes
Primary Outcome Measures
complete resection rate (CRR)
Secondary Outcome Measures
incidence of complications (Intraprocedural bleeding, postprocedural bleeding, and perforation)
necessity of hemostasis (due to Intraprocedural bleeding or postprocedural bleeding)
Polyp retrieval rate
hospitalization period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02476747
Brief Title
Cold Snare Polypectomy Versus. Endoscopic Mucosal Resection
Official Title
Comparison of Efficacy Between Cold Snare Polypectomy and Endoscopic Mucosal Resection in Treatment of Small Polyp
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators will investigate the efficacy of EMR compared to CSP in treatment of small colon polp (6~10mm).
One aim of this study was to investigate the necessity of EMR on resection of small colon polyp.
Detailed Description
With sized polyp from 6mm to less than 10mm, it has been classified by the previous studies as a "small polyp".
Their potential for advanced neoplasia is usually size-dependent, but some recent studies found that, even in diminutive and small polyps, the rate of advanced neoplasia is relatively high about 9%-10%.
The investigators will prospectively investigate postprocedural outcomes, such as retrieval rate, procedural time, overall complication rate (Intraprocedural bleeding, postprocedural bleeding, and perforation) in colonoscopic polypectomy of small polyp between CSP and EMR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp
Keywords
Colonic polyp
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
103 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cold snare polypectomy
Arm Type
Experimental
Arm Description
CSP will be performed by closing the snare loop after positioning the open snare at the point of lesion.
Arm Title
Endoscopic mucosal resection
Arm Type
Active Comparator
Arm Description
EMR will be performed in the way of drawing the lesion into the loop of the snare and resecting followed by saline injection to the its margin.
Intervention Type
Other
Intervention Name(s)
EMR
Intervention Description
performing EMR for patients with small polyp
Intervention Type
Other
Intervention Name(s)
CSP
Intervention Description
performing CSP for patients with small polyp
Primary Outcome Measure Information:
Title
complete resection rate (CRR)
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
incidence of complications (Intraprocedural bleeding, postprocedural bleeding, and perforation)
Time Frame
Up to 2 months
Title
necessity of hemostasis (due to Intraprocedural bleeding or postprocedural bleeding)
Time Frame
Up to 2 months
Title
Polyp retrieval rate
Time Frame
Up to 2 months
Title
hospitalization period
Time Frame
Up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All those over the age of 20 years who agree informed consent and who have at least one polyp of eligible size (6-10 mm)
Exclusion Criteria:
(1) patients taking anticoagulant therapy during the past 1 week of the procedure, (2) known coagulopathy, (3) history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel diseases or significant infectious disease, (4) American Society of Anesthesiology class III or more, and (5) pedunculated polyps and polyps with malignant feature.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong-Sik Byeon, Doctor
Phone
82-2-3010-3905
Email
jsbyeon@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Sik Byeon, Doctor
Organizational Affiliation
Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong-Sik Byeon, Doctor
Phone
82-2-3010-3905
Email
jsbyeon@amc.seoul.kr
12. IPD Sharing Statement
Learn more about this trial
Cold Snare Polypectomy Versus. Endoscopic Mucosal Resection
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