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

Polyp of Large Intestine Clinical Trial

Official title:

Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps: a Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646242
• Other study ID #: CPP2012
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2012
• Last updated: October 13, 2014
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: October 2014
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Polyp of Large Intestine
• Polyps

Intervention

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
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Kyunghee University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Church JM. Clinical significance of small colorectal polyps. Dis Colon Rectum. 2004 Apr;47(4):481-5. Epub 2004 Mar 4. — View Citation

Draganov PV, Chang MN, Alkhasawneh A, Dixon LR, Lieb J, Moshiree B, Polyak S, Sultan S, Collins D, Suman A, Valentine JF, Wagh MS, Habashi SL, Forsmark CE. Randomized, controlled trial of standard, large-capacity versus jumbo biopsy forceps for polypectomy of small, sessile, colorectal polyps. Gastrointest Endosc. 2012 Jan;75(1):118-26. doi: 10.1016/j.gie.2011.08.019. — View Citation

Efthymiou M, Taylor AC, Desmond PV, Allen PB, Chen RY. Biopsy forceps is inadequate for the resection of diminutive polyps. Endoscopy. 2011 Apr;43(4):312-6. doi: 10.1055/s-0030-1256086. Epub 2011 Mar 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete histologic polyp eradication rate		2 weeks	No
Secondary	Time taken for polypectomy (complete visual eradication of each polyp)	time from polyp resection to tissue retrieval	2 weeks	No
Secondary	Successful tissue retrieval rate of removed tissues		2 weeks	No
Secondary	Rates of adverse events	Adverse events include postpolypectomy bleeding and others (polypectomy syndrome or perforation).	4 weeks	Yes
Secondary	Complete visual polyp eradication rate		2 weeks	No