Biopsy Forceps Versus Cold Snare for the Resection of Small Colonic Polyps
Condition: Colonic Polyps
MeSH terms: Polyps; Colonic Polyps
Study type: Interventional

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.
    

Intervention name(s): Jumbo cold forceps polypectomy; Cold snare polypectomy
Intervention type(s): Device; Device
Intervention description(s): 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).; 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colonic Polyps; Polypectomy