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

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

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.

Study Overview

• Status: Completed
• Conditions: Polyp of Colon; Colo-rectal Cancer; Adenomatous Polyp of Colon
• Intervention / Treatment: Procedure: Cold forcep polypectomy; Procedure: Cold snare polypectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Veterans Affairs Palo Alto Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant
• Inflammatory bowel disease
• Polyposis syndromes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completeness of resection	The primary outcome measured is comparison of completeness of resection between the cold forcep and cold snare groups.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to resection	The time between the forceps or snare is introduced till the polyp is removed and retrieved will be compared.	During the procedure
Number of forcep bites or snare attempts	We will compare the number of bites or snare attempts needed to remove the tissue adequately to the endoscopist's judgment.	During the procedure
Complications	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.	4 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Shai Friedland, MD, Stanford University

Publications and helpful links

General Publications

• Wei MT, Louie CY, Chen Y, Pan JY, Quan SY, Wong R, Brown R, Clark M, Jensen K, Lau H, Friedland S. Randomized Controlled Trial Investigating Cold Snare and Forceps Polypectomy Among Small POLYPs in Rates of Complete Resection: The TINYPOLYP Trial. Am J Gastroenterol. 2022 Aug 1;117(8):1305-1310. doi: 10.14309/ajg.0000000000001799. Epub 2022 Apr 25.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): November 20, 2021

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 14, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Intestinal Polyps; Adenoma; Polyps; Colonic Polyps; Adenomatous Polyps
• Other Study ID Numbers: 15766-1

Drug and device information, study documents

• 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