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

Colo-rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551001
• Other study ID #: 15766-1
• Status: Completed
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: November 20, 2021

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: November 20, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 18 years or older

• Polyps <=3mm

Exclusion Criteria:

• Pregnant

• Inflammatory bowel disease

• Polyposis syndromes

Related Conditions & MeSH terms

• Adenomatous Polyp of Colon
• Adenomatous Polyps
• Colo-rectal Cancer
• Colonic Polyps
• Polyp of Colon
• Polyps

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Veterans Affairs Palo Alto Health Care System	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completeness of resection	The primary outcome measured is comparison of completeness of resection between the cold forcep and cold snare groups.	2 weeks
Secondary	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
Secondary	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
Secondary	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