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Clinical Trials/NCT02476747
NCT02476747UnknownNot Applicable

Comparison of Efficacy Between Cold Snare Polypectomy and Endoscopic Mucosal Resection in Treatment of Small Polyp

Asan Medical Center1 site in 1 country103 target enrollmentStarted: June 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
103
Locations
1
Primary Endpoint
complete resection rate (CRR)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Cold snare polypectomy

Experimental

CSP will be performed by closing the snare loop after positioning the open snare at the point of lesion.

Intervention: CSP (Other)

Endoscopic mucosal resection

Active Comparator

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: EMR (Other)

Outcomes

Primary Outcomes

complete resection rate (CRR)

Time Frame: Up to 2 months

Secondary Outcomes

  • incidence of complications (Intraprocedural bleeding, postprocedural bleeding, and perforation)(Up to 2 months)
  • necessity of hemostasis (due to Intraprocedural bleeding or postprocedural bleeding)(Up to 2 months)
  • Polyp retrieval rate(Up to 2 months)
  • hospitalization period(Up to 2 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeong-Sik Byeon

Professor

Asan Medical Center

Study Sites (1)

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