Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy
Primary Purpose
Colo-rectal Cancer, Polyp of Colon, Adenomatous Polyp of Colon
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cold forcep polypectomy
Cold snare polypectomy
Sponsored by
About this trial
This is an interventional treatment trial for Colo-rectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients 18 years or older
- Polyps <=3mm
Exclusion Criteria:
- Pregnant
- Inflammatory bowel disease
- Polyposis syndromes
Sites / Locations
- Veterans Affairs Palo Alto Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cold forcep
Cold snare
Arm Description
Cold forcep polypectomy performed for polyps <=3mm.
Cold forcep polypectomy performed for polyps <=3mm.
Outcomes
Primary Outcome Measures
Completeness of resection
The primary outcome measured is comparison of completeness of resection between the cold forcep and cold snare groups.
Secondary Outcome Measures
Time to resection
The time between the forceps or snare is introduced till the polyp is removed and retrieved will be compared.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04551001
Brief Title
Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy
Official Title
Randomized Controlled Trial Investigating Cold Snare aNd Forcep polypectomY Among Small POLYPs in Rates of Complete Resection: the TINYPOLYP Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
November 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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:
Experimental group: using cold forceps for polyps <=3mm of the colon
Control group: using cold snare for polyps <=3mm of the colon
Methods:
Colonoscopy will be performed in the same standard of care manner as if no study was taking place.
If polyps <=3mm are identified, the endoscopist is randomized to performing polypectomy with cold forcep or cold snare.
After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.
The polyp as well as well as the two biopsies are reviewed by a pathologist.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colo-rectal Cancer, Polyp of Colon, Adenomatous Polyp of Colon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cold forcep
Arm Type
Experimental
Arm Description
Cold forcep polypectomy performed for polyps <=3mm.
Arm Title
Cold snare
Arm Type
Experimental
Arm Description
Cold forcep polypectomy performed for polyps <=3mm.
Intervention Type
Procedure
Intervention Name(s)
Cold forcep polypectomy
Intervention Description
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
Intervention Name(s)
Cold snare polypectomy
Intervention Description
Removal of appropriate polyps using cold snare until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.
Primary Outcome Measure Information:
Title
Completeness of resection
Description
The primary outcome measured is comparison of completeness of resection between the cold forcep and cold snare groups.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Time to resection
Description
The time between the forceps or snare is introduced till the polyp is removed and retrieved will be compared.
Time Frame
During the procedure
Title
Number of forcep bites or snare attempts
Description
We will compare the number of bites or snare attempts needed to remove the tissue adequately to the endoscopist's judgment.
Time Frame
During the procedure
Title
Complications
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients 18 years or older
Polyps <=3mm
Exclusion Criteria:
Pregnant
Inflammatory bowel disease
Polyposis syndromes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shai Friedland, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35467557
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy
We'll reach out to this number within 24 hrs