Clinical trial NCT02239549: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyps
Keywords: Colonic Polyps
Polypectomy
Lead sponsor: San Diego Veterans Healthcare System
Sponsor class: FED
Collaborators: name: University of California, San Diego
First posted: 2014-09-12
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incomplete resection rate
timeFrame: One week after colonoscopy date (when pathology results are available)
Secondary outcomes:
measure: Rate of tissue retrieval
timeFrame: 1 day (At time of colonoscopy)
measure: Rate of procedure-related complications
timeFrame: 1 day (At time of colonoscopy)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Veterans Affairs San Diego Healthcare System
state: California
Study officials:
affiliation: San Diego Veterans Affairs Health Care System
name: Mary Lee Krinsky, D.O.
role: PRINCIPAL_INVESTIGATOR
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