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

September 11, 2014 updated by: Dr. Mary Krinsky, San Diego Veterans Healthcare System

A Prospective Randomized Study Comparing Jumbo Cold Biopsy Forceps Versus Cold Snare for the Resection of Small Colonic Polyps

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

419

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • Veterans Affairs San Diego Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jumbo cold forceps polypectomy group
Polypectomy conducted with jumbo cold forceps
Device: 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).
Experimental: Cold snare polypectomy group
Polypectomy conducted with cold snare
Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incomplete resection rate
Time Frame: One week after colonoscopy date (when pathology results are available)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of tissue retrieval
Time Frame: 1 day (At time of colonoscopy)

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
1 day (At time of colonoscopy)
Rate of procedure-related complications
Time Frame: 1 day (At time of colonoscopy)

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
1 day (At time of colonoscopy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego Veterans Healthcare System

Collaborators

University of California, San Diego

Investigators

  • Principal Investigator: Mary Lee Krinsky, D.O., San Diego Veterans Affairs Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 11, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H130473
  • 090012 (UCSD Human Research Protections Program)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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