Cold Snare Polypectomy Versus. Endoscopic Mucosal Resection

NCT ID: NCT02476747

Last Updated: 2015-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Colonic Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cold snare polypectomy

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

Group Type EXPERIMENTAL

CSP

Intervention Type OTHER

performing CSP for patients with small polyp

Endoscopic mucosal resection

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.

Group Type ACTIVE_COMPARATOR

EMR

Intervention Type OTHER

performing EMR for patients with small polyp

Interventions

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EMR

performing EMR for patients with small polyp

Intervention Type OTHER

CSP

performing CSP for patients with small polyp

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeong-Sik Byeon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong-Sik Byeon, Doctor

Role: STUDY_CHAIR

Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center

Locations

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Asan Medical Center

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jeong-Sik Byeon, Doctor

Role: CONTACT

82-2-3010-3905

Facility Contacts

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Jeong-Sik Byeon, Doctor

Role: primary

82-2-3010-3905

Other Identifiers

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2015-0565

Identifier Type: -

Identifier Source: org_study_id

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