Cold Snare Polypectomy Versus. Endoscopic Mucosal Resection

June 23, 2015 updated by: Jeong-Sik Byeon, Asan Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cold snare polypectomy
CSP will be performed by closing the snare loop after positioning the open snare at the point of lesion.
Other: CSP
performing CSP for patients with small polyp
Active Comparator: 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.
Other: EMR
performing EMR for patients with small polyp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete resection rate (CRR)
Time Frame: Up to 2 months
Up to 2 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Study Chair: Jeong-Sik Byeon, Doctor, Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (Estimate)

June 19, 2015

Study Record Updates

Last Update Posted (Estimate)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 23, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0565

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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