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

NCT ID: NCT04551001

Last Updated: 2022-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-16

Study Completion Date

2021-11-20

Brief Summary

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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

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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.

Conditions

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Colo-rectal Cancer Polyp of Colon Adenomatous Polyp of Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Cold forcep

Cold forcep polypectomy performed for polyps \<=3mm.

Group Type EXPERIMENTAL

Cold forcep polypectomy

Intervention Type 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

Cold forcep polypectomy performed for polyps \<=3mm.

Group Type EXPERIMENTAL

Cold snare polypectomy

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years or older
* Polyps \<=3mm

Exclusion Criteria

* Pregnant
* Inflammatory bowel disease
* Polyposis syndromes
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Shai Friedland

Professor in Gastroenterology & Hepatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shai Friedland, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Veterans Affairs Palo Alto Health Care System

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35467557 (View on PubMed)

Other Identifiers

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15766-1

Identifier Type: -

Identifier Source: org_study_id

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