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

Primary Purpose

Polyp of Large Intestine

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
removal of eligible polyps using cold snare polypectomy technique
removal of eligible polyps using double biopsy technique
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Polyp of Large Intestine

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyunghee University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cold snare polypectomy

Double biopsy polypectomy

Arm Description

Outcomes

Primary Outcome Measures

Complete histologic polyp eradication rate

Secondary Outcome Measures

Time taken for polypectomy (complete visual eradication of each polyp)
time from polyp resection to tissue retrieval
Successful tissue retrieval rate of removed tissues
Rates of adverse events
Adverse events include postpolypectomy bleeding and others (polypectomy syndrome or perforation).
Complete visual polyp eradication rate

Full Information

First Posted
July 16, 2012
Last Updated
October 13, 2014
Sponsor
Kyunghee University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01646242
Brief Title
Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps
Official Title
Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps: a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyp of Large Intestine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cold snare polypectomy
Arm Type
Experimental
Arm Title
Double biopsy polypectomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
removal of eligible polyps using cold snare polypectomy technique
Intervention Description
Snare polypectomy using a mini (10 mm open diameter) size electrosurgical snare without application of electrocautery
Intervention Type
Procedure
Intervention Name(s)
removal of eligible polyps using double biopsy technique
Intervention Description
Cold forceps polypectomy using a standard- capacity forceps with double biopsy technique (two bites per one forceps pass)
Primary Outcome Measure Information:
Title
Complete histologic polyp eradication rate
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Time taken for polypectomy (complete visual eradication of each polyp)
Description
time from polyp resection to tissue retrieval
Time Frame
2 weeks
Title
Successful tissue retrieval rate of removed tissues
Time Frame
2 weeks
Title
Rates of adverse events
Description
Adverse events include postpolypectomy bleeding and others (polypectomy syndrome or perforation).
Time Frame
4 weeks
Title
Complete visual polyp eradication rate
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Kyun Lee, MD, PhD
Organizational Affiliation
Kyung Hee University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyunghee University Medical Center
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
14994108
Citation
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.
Results Reference
background
PubMed Identifier
22196811
Citation
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.
Results Reference
background
PubMed Identifier
21412704
Citation
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.
Results Reference
background
PubMed Identifier
24042189
Citation
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.
Results Reference
derived

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

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