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Completed

NCT Number: NCT04551001

Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy

The focus of the study is to evaluate impact of cold forcep and cold snare in achieving complete resection during polypectomy of polyps <=3mm during colonoscopy.

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Key information

Conditions

Colo-rectal Cancer Adenomatous Polyp of Colon Colonic Diseases Colonic Neoplasms Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyp of Colon Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veterans Affairs Palo Alto Health Care System

Palo Alto, California, 94304, United States

About this study

The details of the proposed study are as follows:

  • Experimental group: using cold forceps for polyps <=3mm of the colon
  • Control group: using cold snare for polyps <=3mm of the colon
  • Methods:
  • Colonoscopy will be performed in the same standard of care manner as if no study was taking place.
  • If polyps <=3mm are identified, the endoscopist is randomized to performing polypectomy with cold forcep or cold snare.
  • After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.
  • The polyp as well as well as the two biopsies are reviewed by a pathologist.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years or older
  • Polyps <=3mm

Exclusion criteria

  • Pregnant
  • Inflammatory bowel disease
  • Polyposis syndromes

Treatment and study plan

Cold forcep polypectomy

Procedure

Removal of appropriate polyps using cold forceps until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.

Cold snare polypectomy

Procedure

Removal of appropriate polyps using cold snare until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.

Primary outcomes

  1. Completeness of resection

    Time frame: 2 weeks

    The primary outcome measured is comparison of completeness of resection between the cold forcep and cold snare groups.

Secondary outcomes

  1. Time to resection

    Time frame: During the procedure

    The time between the forceps or snare is introduced till the polyp is removed and retrieved will be compared.

  2. Number of forcep bites or snare attempts

    Time frame: During the procedure

    We will compare the number of bites or snare attempts needed to remove the tissue adequately to the endoscopist's judgment.

  3. Complications

    Time frame: 4 weeks

    We will compare rates of complications including perforation and immediate post-polypectomy bleeding, early post-polypectomy bleed (within 24 hours) and delayed post polypectomy bleed (between 24 hours and 30 days). Early post-polypectomy bleed and delayed post-polypectomy bleed is evaluated based on emergency room (ER) visit, inpatient stay, transfusion needed, repeat colonoscopy required, surgical intervention required, and mortality.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Randomized Controlled Trial Investigating Cold Snare aNd Forcep polypectomY Among Small POLYPs in Rates of Complete Resection: the TINYPOLYP Trial.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2020
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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