Biopsy Forceps Versus Cold Snare for the Resection of Small Colonic Polyps

NCT02239549 | Completed DMC

• 2 other identifiers: H130473090012
• Study Type: interventional
• Target: 419
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate and compare the incomplete resection rates for small colon polyps less than or equal to 6 mm in size using two conventional polypectomy tools, jumbo cold biopsy forceps and cold snare.

Conditions

Colonic Polyps

Keywords

Colonic Polyps; Polypectomy

Outcome Measures

Primary Outcomes (1)

• Incomplete resection rate

  Resected polyp tissue is collected in a unique specimen jar. Tissue from the perimeter and base of the polyp resection site is collected in separate specimen jar. Histological examination by the pathologist is conducted. Incomplete resection rate = Number of polyps with residual polyp tissue present in biopsy of the perimeter and base of the polypectomy resection site / Total number of polyps This is calculated for polypectomies utilizing either jumbo capacity biopsy forceps or cold snare.

  One week after colonoscopy date (when pathology results are available)

Secondary Outcomes (2)

• Rate of tissue retrieval

  1 day (At time of colonoscopy)

• Rate of procedure-related complications

  1 day (At time of colonoscopy)

Study Arms (2)

Jumbo cold forceps polypectomy group

EXPERIMENTAL

Polypectomy conducted with jumbo cold forceps

Device: Jumbo cold forceps polypectomy

Cold snare polypectomy group

EXPERIMENTAL

Polypectomy conducted with cold snare

Device: Cold snare polypectomy

Interventions

Jumbo cold forceps polypectomy DEVICE

The specific jumbo cold forceps used are the Olympus EndoJaw Biopsy Forceps (open jaw diameter 8.5 mm) and the Boston Scientific RJ4 Biopsy Forceps (open jaw diameter 8.8 mm).

Jumbo cold forceps polypectomy group

Cold snare polypectomy DEVICE

The specific cold snares used are the Boston Scientific Captiflex Extra Small Oval Flexible Snare (loop width 11 mm), the US Endoscopy Dsnare Dimunitive Polypectomy and Suction System (loop width 9 mm), or the Boston Scientific Sensation Short Throw Oval Flexible Snare (loop width of 13 mm, 27 mm, or 30 mm).

Cold snare polypectomy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18 and 80 years
• Undergoing routine colonoscopy

You may not qualify if:

• Inflammatory bowel disease
• Cognitive impairment
• Pregnancy
• Presence of a coagulation disorder
• Use of anticoagulant, antiplatelet, or non-steroidal anti-inflammatory drug therapy during the 1 week prior to colonoscopy

Sponsors & Collaborators

• San Diego Veterans Healthcare System: lead
• University of California, San Diego: collaborator

Study Sites (1)

Veterans Affairs San Diego Healthcare System

San Diego, California, 92161, United States

Location

Related Publications (15)

• Pohl H, Srivastava A, Bensen SP, Anderson P, Rothstein RI, Gordon SR, Levy LC, Toor A, Mackenzie TA, Rosch T, Robertson DJ. Incomplete polyp resection during colonoscopy-results of the complete adenoma resection (CARE) study. Gastroenterology. 2013 Jan;144(1):74-80.e1. doi: 10.1053/j.gastro.2012.09.043. Epub 2012 Sep 25.

  PMID: 23022496 BACKGROUND

• 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.

  PMID: 14994108 BACKGROUND

• Kapsoritakis AN, Potamianos SP, Koukourakis MI, Tzardi M, Mouzas IA, Roussomoustakaki M, Alexandrakis G, Kouroumalis EA. Diminutive polyps of large bowel should be an early target for endoscopic treatment. Dig Liver Dis. 2002 Feb;34(2):137-40. doi: 10.1016/s1590-8658(02)80244-4.

  PMID: 11926558 BACKGROUND

• 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.

  PMID: 21412704 BACKGROUND

• Jung YS, Park JH, Kim HJ, Cho YK, Sohn CI, Jeon WK, Kim BI, Sohn JH, Park DI. Complete biopsy resection of diminutive polyps. Endoscopy. 2013 Dec;45(12):1024-9. doi: 10.1055/s-0033-1344394. Epub 2013 Aug 6.

  PMID: 23921846 BACKGROUND

• 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.

  PMID: 24042189 BACKGROUND

• Liu S, Ho SB, Krinsky ML. Quality of polyp resection during colonoscopy: are we achieving polyp clearance? Dig Dis Sci. 2012 Jul;57(7):1786-91. doi: 10.1007/s10620-012-2115-6. Epub 2012 Mar 30.

  PMID: 22461018 BACKGROUND

• Woods A, Sanowski RA, Wadas DD, Manne RK, Friess SW. Eradication of diminutive polyps: a prospective evaluation of bipolar coagulation versus conventional biopsy removal. Gastrointest Endosc. 1989 Nov-Dec;35(6):536-40. doi: 10.1016/s0016-5107(89)72906-0.

  PMID: 2689263 BACKGROUND

• Elmunzer BJ, Higgins PD, Kwon YM, Golembeski C, Greenson JK, Korsnes SJ, Elta GH. Jumbo forceps are superior to standard large-capacity forceps in obtaining diagnostically adequate inflammatory bowel disease surveillance biopsy specimens. Gastrointest Endosc. 2008 Aug;68(2):273-8; quiz 334, 336. doi: 10.1016/j.gie.2007.11.023. Epub 2007 Dec 26.

  PMID: 18155204 BACKGROUND

• 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.

  PMID: 22196811 BACKGROUND

• Deenadayalu VP, Rex DK. Colon polyp retrieval after cold snaring. Gastrointest Endosc. 2005 Aug;62(2):253-6. doi: 10.1016/s0016-5107(05)00376-7.

  PMID: 16046990 BACKGROUND

• Ichise Y, Horiuchi A, Nakayama Y, Tanaka N. Prospective randomized comparison of cold snare polypectomy and conventional polypectomy for small colorectal polyps. Digestion. 2011;84(1):78-81. doi: 10.1159/000323959. Epub 2011 Apr 14.

  PMID: 21494037 BACKGROUND

• Komeda Y, Suzuki N, Sarah M, Thomas-Gibson S, Vance M, Fraser C, Patel K, Saunders BP. Factors associated with failed polyp retrieval at screening colonoscopy. Gastrointest Endosc. 2013 Mar;77(3):395-400. doi: 10.1016/j.gie.2012.10.007. Epub 2012 Dec 1.

  PMID: 23211749 BACKGROUND

• Tappero G, Gaia E, De Giuli P, Martini S, Gubetta L, Emanuelli G. Cold snare excision of small colorectal polyps. Gastrointest Endosc. 1992 May-Jun;38(3):310-3. doi: 10.1016/s0016-5107(92)70422-2.

  PMID: 1607081 BACKGROUND

• Repici A, Hassan C, Vitetta E, Ferrara E, Manes G, Gullotti G, Princiotta A, Dulbecco P, Gaffuri N, Bettoni E, Pagano N, Rando G, Strangio G, Carlino A, Romeo F, de Paula Pessoa Ferreira D, Zullo A, Ridola L, Malesci A. Safety of cold polypectomy for <10mm polyps at colonoscopy: a prospective multicenter study. Endoscopy. 2012 Jan;44(1):27-31. doi: 10.1055/s-0031-1291387. Epub 2011 Nov 28.

  PMID: 22125197 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary Lee Krinsky, D.O.

  San Diego Veterans Affairs Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Medicine

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 12, 2014
• Study Start: April 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: March 1, 2014
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

US (1)