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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Chang Kyun Lee, Kyunghee University Medical Center

ClinicalTrials.gov Identifier:

NCT01646242

First received: July 16, 2012

Last updated: January 15, 2013

Last verified: January 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Polyp of Large Intestine	Procedure: removal of eligible polyps using cold snare polypectomy technique Procedure: removal of eligible polyps using double biopsy technique	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps: a Prospective Randomized Trial

Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:

Complete histologic polyp eradication rate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time taken for polypectomy (complete visual eradication of each polyp) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
time from polyp resection to tissue retrieval
Successful tissue retrieval rate of removed tissues [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Rates of adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Adverse events include postpolypectomy bleeding and others (polypectomy syndrome or perforation).
Complete visual polyp eradication rate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	116
Study Start Date:	July 2012
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cold snare polypectomy	Procedure: 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
Experimental: Double biopsy polypectomy	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)

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646242

Locations

Korea, Republic of
Kyunghee University Medical Center
Seoul, Korea, Republic of, 130-702

Sponsors and Collaborators

Kyunghee University Medical Center

Investigators

Principal Investigator:

Chang Kyun Lee, MD, PhD

Kyung-Hee University Hospital

More Information

Publications:

Church JM. Clinical significance of small colorectal polyps. Dis Colon Rectum. 2004 Apr;47(4):481-5. Epub 2004 Mar 4.

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.

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. Epub 2011 Mar 16.

Responsible Party:	Chang Kyun Lee, Assistant Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:	NCT01646242 History of Changes
Other Study ID Numbers:	CPP2012
Study First Received:	July 16, 2012
Last Updated:	January 15, 2013
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps

ClinicalTrials.gov processed this record on May 22, 2013

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