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Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps

Primary Purpose

Colon Polyps

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cold Biopsy forceps
Cold snare biopsy
Sponsored by
Incheon St.Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Polyps focused on measuring cold biopsy forceps, cold snare biopsy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Incheon St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cold biopsy forceps

Cold Snare Biopsy

Arm Description

Cold biopsy forceps for removal of colon polyps

Cold snare biopsy for removal of colon polyps

Outcomes

Primary Outcome Measures

Comparing the complete removal rate of cold biopsy forceps versus cold snare biopsy for removing colon polyps
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
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

Full Information

First Posted
August 9, 2012
Last Updated
March 24, 2015
Sponsor
Incheon St.Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01665898
Brief Title
Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps
Official Title
Randomized Controlled Trial Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Incheon St.Mary's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyps
Keywords
cold biopsy forceps, cold snare biopsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cold biopsy forceps
Arm Type
Active Comparator
Arm Description
Cold biopsy forceps for removal of colon polyps
Arm Title
Cold Snare Biopsy
Arm Type
Active Comparator
Arm Description
Cold snare biopsy for removal of colon polyps
Intervention Type
Procedure
Intervention Name(s)
Cold Biopsy forceps
Intervention Description
removal of polyps using cold biopsy forceps
Intervention Type
Procedure
Intervention Name(s)
Cold snare biopsy
Intervention Description
Removal of colon polyps using cold snare biopsy
Primary Outcome Measure Information:
Title
Comparing the complete removal rate of cold biopsy forceps versus cold snare biopsy for removing colon polyps
Description
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.
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Bleeding rate after removal of colon polyps by using cold biopsy forceps or cold snare biopsy
Description
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
Time Frame
participants will be followed up for 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo-In Lee
Organizational Affiliation
Incheon St.Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Incheon St. Mary's Hospital
City
Incheon
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25708763
Citation
Kim JS, Lee BI, Choi H, Jun SY, Park ES, Park JM, Lee IS, Kim BW, Kim SW, Choi MG. Cold snare polypectomy versus cold forceps polypectomy for diminutive and small colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2015 Mar;81(3):741-7. doi: 10.1016/j.gie.2014.11.048.
Results Reference
derived

Learn more about this trial

Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps

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