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

Not Applicable

Completed

• Conditions: Polyp of Colon; Colo-rectal Cancer; Adenomatous Polyp of Colon
• Interventions: Procedure: Cold forcep polypectomy; Procedure: Cold snare polypectomy

• Registration Number: NCT04551001
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-09
• Study Start: 2020-09-16
• Study First Posted: 2020-09-16
• Primary Completion: 2021-10-15
• Study Completion: 2021-11-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-14
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

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

Read More

Exclusion Criteria

• Pregnant
• Inflammatory bowel disease
• Polyposis syndromes

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold forcep	Cold forcep polypectomy	Cold forcep polypectomy performed for polyps \<=3mm.
Cold snare	Cold snare polypectomy	Cold forcep polypectomy performed for polyps \<=3mm.

Primary Outcome Measures

Name	Time	Method
Completeness of resection	2 weeks	The primary outcome measured is comparison of completeness of resection between the cold forcep and cold snare groups.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Veterans Affairs Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States