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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 26, 2014