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Cold Snare Polypectomy Vs. Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps

Primary Purpose

Polyp of Large Intestine

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Cold biopsy polypectomy

Cold snare polypectomy

Cold biopsy polypectomy

About this trial

This is an interventional diagnostic trial for Polyp of Large Intestine

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

patients over the age of 20 years undergoing routine colonoscopy (screening, surveillance, or diagnostic)

Exclusion Criteria:

patients taking antiplatelet or anticoagulant therapy during the past 1 week of the procedure
known coagulopathy
history of inflammatory bowel diseases
American Society of Anesthesiology class III or more
pregnancy.

Sites / Locations

Soonchunhyang University Hospital, Bucheon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

cold biopsy polypectomy

Cold snare polypectomy

Arm Description

Outcomes

Primary Outcome Measures

complete histologic polyp eradication rate

Secondary Outcome Measures

rates of tissue retrieval per polyp

Full Information

NCT ID

NCT02201147

First Posted

July 22, 2014

Last Updated

May 2, 2015

Sponsor

Soonchunhyang University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02201147

Brief Title

Cold Snare Polypectomy Vs. Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps

Official Title

Prospective Comparison of Cold Snare Polypectomy and Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Diminutive Colorectal Polyps

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Soonchunhyang University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to compare cold snare polypectomy and cold forceps polypectomy using narrow-band imaging endoscopy for removal of diminutive colorectal polyps.

Detailed Description

Previous study found Cold snare polypectomy a preferable technique in comparison to cold biopsy for diminutive polyps when assessed for completeness of resection. However, it is expected that cold biopsy polypectomy with advanced endoscopy, such as chromoendoscopy or narrow-band imaging endoscopy, increase completeness of resection. One study showed 90% of the diminutive polyps were completely resected using cold biopsy polypectomy with chromoendoscopy. However, no study compared cold snare polypectomy and cold biopsy polypectomy using Narrow-band Imaging endoscopy for Removal of Diminutive Colorectal Polyps. The aim of this study is to compare cold snare polypectomy and Cold biopsy Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polyp of Large Intestine

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

146 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cold biopsy polypectomy

Arm Type

Experimental

Arm Title

Cold snare polypectomy

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Cold biopsy polypectomy

Intervention Description

removal of eligible polyps using cold biopsy technique until no polyp was visible by narrow-band imaging endoscopy

Intervention Type

Procedure

Intervention Name(s)

Cold snare polypectomy

Intervention Description

removal of eligible polyps using cold snare polypectomy technique

Intervention Type

Device

Intervention Name(s)

Cold snare polypectomy

Intervention Description

mini (10 mm open diameter) size electrosurgical snare without application of electrocautery

Intervention Type

Device

Intervention Name(s)

Cold biopsy polypectomy

Intervention Description

standard- capacity forceps with narrow band imaging endoscopy

Primary Outcome Measure Information:

Title

complete histologic polyp eradication rate

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

rates of tissue retrieval per polyp

Time Frame

2 weeks

Other Pre-specified Outcome Measures:

Title

polypectomy procedure times

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients over the age of 20 years undergoing routine colonoscopy (screening, surveillance, or diagnostic) Exclusion Criteria: patients taking antiplatelet or anticoagulant therapy during the past 1 week of the procedure known coagulopathy history of inflammatory bowel diseases American Society of Anesthesiology class III or more pregnancy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bong Min Ko, MD

Organizational Affiliation

SoonChunHyang University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Soonchunhyang University Hospital, Bucheon

City

Bucheon

ZIP/Postal Code

420-767

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

26358331

Citation

Park SK, Ko BM, Han JP, Hong SJ, Lee MS. A prospective randomized comparative study of cold forceps polypectomy by using narrow-band imaging endoscopy versus cold snare polypectomy in patients with diminutive colorectal polyps. Gastrointest Endosc. 2016 Mar;83(3):527-32.e1. doi: 10.1016/j.gie.2015.08.053. Epub 2015 Sep 7.

Results Reference

derived

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Cold Snare Polypectomy Vs. Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps

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