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

Polyp of Large Intestine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201147
• Other study ID #: 2014-04-041
• Status: Completed
• Phase: N/A
• First received: July 22, 2014
• Last updated: May 2, 2015
• Start date: July 2014
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Polyp of Large Intestine
• Polyps

Intervention

Procedure:
• Cold biopsy polypectomy
removal of eligible polyps using cold biopsy technique until no polyp was visible by narrow-band imaging endoscopy
• Cold snare polypectomy
removal of eligible polyps using cold snare polypectomy technique

Device:
• Cold snare polypectomy
mini (10 mm open diameter) size electrosurgical snare without application of electrocautery
• Cold biopsy polypectomy
standard- capacity forceps with narrow band imaging endoscopy

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Hospital, Bucheon	Bucheon

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	polypectomy procedure times		2 weeks	No
Primary	complete histologic polyp eradication rate		2 weeks	No
Secondary	rates of tissue retrieval per polyp		2 weeks	No