We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01646242
First Posted: July 20, 2012
Last Update Posted: October 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chang Kyun Lee, Kyunghee University Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps: a Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Chang Kyun Lee, Kyunghee University Medical Center:

Primary Outcome Measures:
  • Complete histologic polyp eradication rate [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • Time taken for polypectomy (complete visual eradication of each polyp) [ Time Frame: 2 weeks ]
    time from polyp resection to tissue retrieval

  • Successful tissue retrieval rate of removed tissues [ Time Frame: 2 weeks ]
  • Rates of adverse events [ Time Frame: 4 weeks ]
    Adverse events include postpolypectomy bleeding and others (polypectomy syndrome or perforation).

  • Complete visual polyp eradication rate [ Time Frame: 2 weeks ]

Enrollment: 54
Study Start Date: July 2012
Study Completion Date: June 2013
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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