Biopsy Forceps Versus Cold Snare for the Resection of Small Colonic Polyps
NCT ID: NCT02239549
Last Updated: 2014-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
419 participants
INTERVENTIONAL
2009-04-30
2014-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal
NCT04727918
Comparison of Two Types of Biopsy Forceps for Obtaining Cold Biopsy Polypectomy for Small Sessile Colorectal Polyps Less Than 6 mm in Diameter
NCT00855790
Cold Snare Polypectomy Vs. Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps
NCT02201147
Cold Snare Versus Double Biopsy Polypectomy Technique for Removal of Diminutive Colorectal Polyps
NCT01646242
Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy
NCT04551001
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All patients undergo standard bowel preparation with 4 liters of polyethylene glycol solution for routine colonoscopy. All colonoscopies are performed using standard colonoscopes (Olympus CF/PCF 160, CF/PCF 180, H-CF/H-PCF 180). Polypectomy tools used are: Olympus Biopsy Forceps, Boston Scientific RJ4 Biopsy Forceps, Boston Scientific Captiflex Extra Small Oval Flexible Snare, US Endoscopy Dsnare Dimunitive Polypectomy and Suction System, and the Boston Scientific Sensation Short Throw Oval Flexible Snare. For all polyps less than or equal to 6 mm in size, documentation of polyp size and anatomic location is conducted.
The jumbo capacity cold forceps polypectomy technique is performed via the following method: After inspection of the polyp, one or more biopsies are taken of the polyp followed by retrieval of the specimens directly from the biopsy forceps. Thereafter, the polypectomy site is vigorously irrigated and visually inspected for evidence of residual polypoid tissue. If residual polypoid tissue is suspected, additional biopsies are taken until the site is considered devoid of polypoid tissue. The total number of bites required for visual completion of polypectomy is recorded.
The cold snare polypectomy technique is performed via the following method: After inspection of the polyp, the snare is used to encircle the polyp with a few millimeter rim of surrounding normal mucosa. The cold snare is used to mechanically transect the polyp without tenting. Thereafter, the resected polyp specimen is suctioned through the colonoscope channel into a trap and retrieval is documented. Next, the polypectomy site is vigorously irrigated and visually inspected for evidence of residual polypoid tissue. If polypoid tissue is still suspected, additional snare excision is performed. The total number of snare excisions required for visual completion of polypectomy is recorded.
For both polypectomy methods, after polyp removal is considered complete, the base and perimeter of the polypectomy site is sampled with a jumbo capacity biopsy forceps with one to three additional biopsies to evaluate for the presence of residual polypoid tissue. All pathology results for the polyp specimens and the polypectomy base specimens are interpreted by a group of VA or UCSD affiliated pathologists.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Jumbo cold forceps polypectomy group
Polypectomy conducted with jumbo cold forceps
Jumbo cold forceps polypectomy
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).
Cold snare polypectomy group
Polypectomy conducted with cold snare
Cold snare polypectomy
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Jumbo cold forceps polypectomy
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).
Cold snare polypectomy
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Undergoing routine colonoscopy
Exclusion Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Diego
OTHER
San Diego Veterans Healthcare System
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Mary Krinsky
Clinical Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mary Lee Krinsky, D.O.
Role: PRINCIPAL_INVESTIGATOR
San Diego Veterans Affairs Health Care System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Veterans Affairs San Diego Healthcare System
San Diego, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
090012
Identifier Type: OTHER
Identifier Source: secondary_id
H130473
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.