Biopsy Forceps Versus Cold Snare for the Resection of Small Colonic Polyps
Primary Purpose
Colonic Polyps
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Jumbo cold forceps polypectomy
Cold snare polypectomy
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Polyps focused on measuring Colonic Polyps, Polypectomy
Eligibility Criteria
Inclusion Criteria:
- Patients between the ages of 18 and 80 years
- Undergoing routine colonoscopy
Exclusion Criteria:
- 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
Sites / Locations
- Veterans Affairs San Diego Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Jumbo cold forceps polypectomy group
Cold snare polypectomy group
Arm Description
Polypectomy conducted with jumbo cold forceps
Polypectomy conducted with cold snare
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rate of tissue retrieval
Documentation of whether resected polyp tissue is actually retrieved for placement into specimen jar.
Rate of tissue retrieval = Number of effectively retrieved polyps for placement into specimen jar / Total number of resected polyps
Rate of procedure-related complications
The two procedure related complications that were specifically assessed were post-polypectomy bleeding or perforation.
Rate of procedure-related complications = Number of colonoscopies with complication of post-polypectomy bleeding or perforation / Total number of colonoscopies
Full Information
NCT ID
NCT02239549
First Posted
September 10, 2014
Last Updated
September 11, 2014
Sponsor
San Diego Veterans Healthcare System
Collaborators
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT02239549
Brief Title
Biopsy Forceps Versus Cold Snare for the Resection of Small Colonic Polyps
Official Title
A Prospective Randomized Study Comparing Jumbo Cold Biopsy Forceps Versus Cold Snare for the Resection of Small Colonic Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego Veterans Healthcare System
Collaborators
University of California, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The study is a prospective, randomized controlled study involving outpatients undergoing routine colonoscopy. The study is conducted at two academic medical centers, the Veterans Affairs (VA) San Diego Healthcare System and the University of California San Diego (UCSD) Thornton Hospital. Written informed consent is obtained from all participants prior to any study related procedures. Upon enrollment, each patient is randomized via a computer generated randomization scheme to a polypectomy device, either jumbo cold biopsy forceps or cold snare. The randomly allocated polypectomy device is used for polyp resection for polyps less than or equal to 6 mm in size.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps
Keywords
Colonic Polyps, Polypectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
419 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Jumbo cold forceps polypectomy group
Arm Type
Experimental
Arm Description
Polypectomy conducted with jumbo cold forceps
Arm Title
Cold snare polypectomy group
Arm Type
Experimental
Arm Description
Polypectomy conducted with cold snare
Intervention Type
Device
Intervention Name(s)
Jumbo cold forceps polypectomy
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Cold snare polypectomy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Incomplete resection rate
Description
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.
Time Frame
One week after colonoscopy date (when pathology results are available)
Secondary Outcome Measure Information:
Title
Rate of tissue retrieval
Description
Documentation of whether resected polyp tissue is actually retrieved for placement into specimen jar.
Rate of tissue retrieval = Number of effectively retrieved polyps for placement into specimen jar / Total number of resected polyps
Time Frame
1 day (At time of colonoscopy)
Title
Rate of procedure-related complications
Description
The two procedure related complications that were specifically assessed were post-polypectomy bleeding or perforation.
Rate of procedure-related complications = Number of colonoscopies with complication of post-polypectomy bleeding or perforation / Total number of colonoscopies
Time Frame
1 day (At time of colonoscopy)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients between the ages of 18 and 80 years
Undergoing routine colonoscopy
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Lee Krinsky, D.O.
Organizational Affiliation
San Diego Veterans Affairs Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
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Biopsy Forceps Versus Cold Snare for the Resection of Small Colonic Polyps
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