- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02201147
Cold Snare Polypectomy Vs. Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps
Prospective Comparison of Cold Snare Polypectomy and Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Diminutive Colorectal Polyps
Study Overview
Status
Conditions
Detailed Description
Previous study found Cold snare polypectomy a preferable technique in comparison to cold biopsy for diminutive polyps when assessed for completeness of resection. However, it is expected that cold biopsy polypectomy with advanced endoscopy, such as chromoendoscopy or narrow-band imaging endoscopy, increase completeness of resection. One study showed 90% of the diminutive polyps were completely resected using cold biopsy polypectomy with chromoendoscopy. However, no study compared cold snare polypectomy and cold biopsy polypectomy using Narrow-band Imaging endoscopy for Removal of Diminutive Colorectal Polyps.
The aim of this study is to compare cold snare polypectomy and Cold biopsy Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bucheon, Korea, Republic of, 420-767
- Soonchunhyang University Hospital, Bucheon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients over the age of 20 years undergoing routine colonoscopy (screening, surveillance, or diagnostic)
Exclusion Criteria:
- patients taking antiplatelet or anticoagulant therapy during the past 1 week of the procedure
- known coagulopathy
- history of inflammatory bowel diseases
- American Society of Anesthesiology class III or more
- pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: cold biopsy polypectomy
|
removal of eligible polyps using cold biopsy technique until no polyp was visible by narrow-band imaging endoscopy
standard- capacity forceps with narrow band imaging endoscopy
|
|
Experimental: Cold snare polypectomy
|
removal of eligible polyps using cold snare polypectomy technique
mini (10 mm open diameter) size electrosurgical snare without application of electrocautery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
complete histologic polyp eradication rate
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
rates of tissue retrieval per polyp
Time Frame: 2 weeks
|
2 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
polypectomy procedure times
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bong Min Ko, MD, Soonchunhyang University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-04-041
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