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Clinical Trials/NCT04551001
NCT04551001
Completed
Not Applicable

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

Stanford University1 site in 1 country181 target enrollmentSeptember 16, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colo-rectal Cancer
Sponsor
Stanford University
Enrollment
181
Locations
1
Primary Endpoint
Completeness of resection
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 16, 2020
End Date
November 20, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shai Friedland

Professor in Gastroenterology & Hepatology

Stanford University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Inflammatory bowel disease
  • Polyposis syndromes

Outcomes

Primary Outcomes

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 Outcomes

  • Time to resection(During the procedure)
  • Complications(4 weeks)
  • Number of forcep bites or snare attempts(During the procedure)

Study Sites (1)

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