Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Kyun Lee, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01646242
First received: July 16, 2012
Last updated: October 13, 2014
Last verified: October 2014

July 16, 2012
October 13, 2014
July 2012
June 2013   (final data collection date for primary outcome measure)
Complete histologic polyp eradication rate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete visual polyp eradication rate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01646242 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time for 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 histological polyp eradication rate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps
Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps: a Prospective Randomized Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Polyp of Large Intestine
  • 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
  • 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)
  • Experimental: Cold snare polypectomy
    Intervention: Procedure: removal of eligible polyps using cold snare polypectomy technique
  • Experimental: Double biopsy polypectomy
    Intervention: Procedure: removal of eligible polyps using double biopsy technique

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01646242
CPP2012
Yes
Chang Kyun Lee, Kyunghee University Medical Center
Kyunghee University Medical Center
Not Provided
Principal Investigator: Chang Kyun Lee, MD, PhD Kyung-Hee University Hospital
Kyunghee University Medical Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP