Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps

NCT ID: NCT01646242

Last Updated: 2014-10-15

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-06-30

Brief Summary

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Most of colorectal polyps founded during colonoscopy are diminutive polyps less than 6 mm. However, complete removal of diminutive polyps is required to prevent tumor recurrence and development of potential interval cancers. Currently, a variety of polypectomy techniques such as hot snare, cold snare, and cold forceps polypectomy are frequently used for the removal of diminutive colorectal polyps. In regard to the completeness of polypectomy, there are few data comparing cold snare polypectomy with cold forceps biopsy technique for removal of diminutive (1-5 mm) colorectal polyps. The aim of this study is to compare cold snare polypectomy with cold forceps polypectomy using double biopsy technique for removal of diminutive colorectal polyps.

Detailed Description

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Conditions

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Polyp of Large Intestine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cold snare polypectomy

Group Type EXPERIMENTAL

removal of eligible polyps using cold snare polypectomy technique

Intervention Type PROCEDURE

Snare polypectomy using a mini (10 mm open diameter) size electrosurgical snare without application of electrocautery

Double biopsy polypectomy

Group Type EXPERIMENTAL

removal of eligible polyps using double biopsy technique

Intervention Type PROCEDURE

Cold forceps polypectomy using a standard- capacity forceps with double biopsy technique (two bites per one forceps pass)

Interventions

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removal of eligible polyps using cold snare polypectomy technique

Snare polypectomy using a mini (10 mm open diameter) size electrosurgical snare without application of electrocautery

Intervention Type PROCEDURE

removal of eligible polyps using double biopsy technique

Cold forceps polypectomy using a standard- capacity forceps with double biopsy technique (two bites per one forceps pass)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients over the age of 20
* Informed consent

Exclusion Criteria

* Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy
* Known existing bleeding tendency (thrombocytopenia or prolonged INR)
* Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis)
* ASA class III or more
* Pregnancy
* Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyunghee University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Chang Kyun Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang Kyun Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Hospital

Locations

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Kyunghee University Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Church JM. Clinical significance of small colorectal polyps. Dis Colon Rectum. 2004 Apr;47(4):481-5. doi: 10.1007/s10350-003-0078-6. Epub 2004 Mar 4.

Reference Type BACKGROUND
PMID: 14994108 (View on PubMed)

Draganov PV, Chang MN, Alkhasawneh A, Dixon LR, Lieb J, Moshiree B, Polyak S, Sultan S, Collins D, Suman A, Valentine JF, Wagh MS, Habashi SL, Forsmark CE. Randomized, controlled trial of standard, large-capacity versus jumbo biopsy forceps for polypectomy of small, sessile, colorectal polyps. Gastrointest Endosc. 2012 Jan;75(1):118-26. doi: 10.1016/j.gie.2011.08.019.

Reference Type BACKGROUND
PMID: 22196811 (View on PubMed)

Efthymiou M, Taylor AC, Desmond PV, Allen PB, Chen RY. Biopsy forceps is inadequate for the resection of diminutive polyps. Endoscopy. 2011 Apr;43(4):312-6. doi: 10.1055/s-0030-1256086. Epub 2011 Mar 16.

Reference Type BACKGROUND
PMID: 21412704 (View on PubMed)

Lee CK, Shim JJ, Jang JY. Cold snare polypectomy vs. Cold forceps polypectomy using double-biopsy technique for removal of diminutive colorectal polyps: a prospective randomized study. Am J Gastroenterol. 2013 Oct;108(10):1593-600. doi: 10.1038/ajg.2013.302. Epub 2013 Sep 17.

Reference Type DERIVED
PMID: 24042189 (View on PubMed)

Other Identifiers

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CPP2012

Identifier Type: -

Identifier Source: org_study_id

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