Clinical trial NCT01646242: Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps
Official title: Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polyp of Large Intestine
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Complete histologic polyp eradication rate
timeFrame: 2 weeks
Secondary outcomes:
measure: Time taken for polypectomy (complete visual eradication of each polyp)
timeFrame: 2 weeks
measure: Successful tissue retrieval rate of removed tissues
timeFrame: 2 weeks
measure: Rates of adverse events
timeFrame: 4 weeks
measure: Complete visual polyp eradication rate
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
Study officials:
affiliation: Kyung Hee University Hospital
name: Chang Kyun Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Church JM. Clinical significance of small colorectal polyps. Dis Colon Rectum. 2004 Apr;47(4):481-5. doi: 10.1007/s10350-003-0078-6. Epub 2004 Mar 4.
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.
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.
citation: Lee CK, Shim JJ, Jang JY. Cold snare polypectomy vs. Cold forceps polypectomy using double-biopsy technique for removal of diminutive colorectal polyps: a prospective randomized study. Am J Gastroenterol. 2013 Oct;108(10):1593-600. doi: 10.1038/ajg.2013.302. Epub 2013 Sep 17.