Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joon Sung Kim, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01665898
First received: August 9, 2012
Last updated: March 24, 2015
Last verified: March 2015
  Purpose

Comparing the efficacy of cold biopsy forceps versus cold snare biopsy for removing colon polyps.


Condition Intervention
Colon Polyps
Procedure: Cold Biopsy forceps
Procedure: Cold snare biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps

Resource links provided by NLM:


Further study details as provided by Incheon St.Mary's Hospital:

Primary Outcome Measures:
  • Comparing the complete removal rate of cold biopsy forceps versus cold snare biopsy for removing colon polyps [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
    We will investigate the complete removal rate of colon polyps by using two different methods, cold biopsy forceps or cold snare biopsy. After removal of polyps by one of these two methods, the remnant lesion will be biopsied to study if there are any remnant tissues in order to find out the complete removal rate.


Secondary Outcome Measures:
  • Bleeding rate after removal of colon polyps by using cold biopsy forceps or cold snare biopsy [ Time Frame: participants will be followed up for 1 month ] [ Designated as safety issue: Yes ]
    We will investigate bleeding rate after removal of colon polyps by these two methods. Bleeding rate will be the number of patients who showed significant bleeding after the procedure divided by the total number of patients who will receive the procedure. Significant bleeding was determined to be ongoing bleeding for more than 30 seconds after the procedure


Enrollment: 138
Study Start Date: August 2012
Study Completion Date: March 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cold biopsy forceps
Cold biopsy forceps for removal of colon polyps
Procedure: Cold Biopsy forceps
removal of polyps using cold biopsy forceps
Active Comparator: Cold Snare Biopsy
Cold snare biopsy for removal of colon polyps
Procedure: Cold snare biopsy
Removal of colon polyps using cold snare biopsy

Detailed Description:

Polyps were randomized to be treated with either CSP or CFP. After the initial polypectomy, additional EMR was performed at the polypectomy site to assess the presence of residual polyp tissue.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients older than 40 years old and
  • patients who are receiving colonoscopies and
  • patients who have colon polyps

Exclusion Criteria:

  • patients who have not agreed to the study
  • patients with bleeding tendencies
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01665898

Locations
Korea, Republic of
Incheon St. Mary's Hospital
Incheon, Korea, Republic of
Sponsors and Collaborators
Incheon St.Mary's Hospital
Investigators
Principal Investigator: Bo-In Lee Incheon St.Mary's Hospital
  More Information

No publications provided

Responsible Party: Joon Sung Kim, Instructor, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier: NCT01665898     History of Changes
Other Study ID Numbers: IncheonSMH, OC12OISI0067
Study First Received: August 9, 2012
Last Updated: March 24, 2015
Health Authority: Korea: Institutional Review Board

Keywords provided by Incheon St.Mary's Hospital:
cold biopsy forceps
cold snare biopsy

Additional relevant MeSH terms:
Colonic Polyps
Polyps
Intestinal Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 19, 2015