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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551001
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Shai Friedland, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colo-rectal Cancer Polyp of Colon Adenomatous Polyp of Colon Procedure: Cold forcep polypectomy Procedure: Cold snare polypectomy Not Applicable

Detailed Description:

The details of the proposed study are as follows:

  1. Experimental group: using cold forceps for polyps <=3mm of the colon
  2. Control group: using cold snare for polyps <=3mm of the colon
  3. Methods:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Investigating Cold Snare aNd Forcep polypectomY Among Small POLYPs in Rates of Complete Resection: the TINYPOLYP Trial.
Actual Study Start Date : September 16, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Cold forcep
Cold forcep polypectomy performed for polyps <=3mm.
Procedure: Cold forcep polypectomy
Removal of appropriate polyps using cold forceps until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.

Experimental: Cold snare
Cold forcep polypectomy performed for polyps <=3mm.
Procedure: Cold snare polypectomy
Removal of appropriate polyps using cold snare until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  • Inflammatory bowel disease
  • Polyposis syndromes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551001


Contacts
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Contact: Mike Wei, MD 650-723-4000 mtwei@stanford.edu
Contact: Shai Friedland, MD 650-723-4000 shaif@stanford.edu

Locations
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United States, California
Veterans Affairs Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Mike Wei, MD    650-723-4000    mtwei@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Shai Friedland, MD Stanford University
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Responsible Party: Shai Friedland, Professor in Gastroenterology & Hepatology, Stanford University
ClinicalTrials.gov Identifier: NCT04551001    
Other Study ID Numbers: 15766-1
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Adenomatous Polyps
Polyps
Colonic Polyps
Neoplasms
Pathological Conditions, Anatomical
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Polyps