Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy
Randomized Controlled Trial Investigating Cold Snare aNd Forcep polypectomY Among Small POLYPs in Rates of Complete Resection: the TINYPOLYP Trial.
1 other identifier
interventional
181
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Sep 2020
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedStudy Start
First participant enrolled
September 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2021
CompletedMay 17, 2022
May 1, 2022
1.1 years
September 9, 2020
May 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Completeness of resection
The primary outcome measured is comparison of completeness of resection between the cold forcep and cold snare groups.
2 weeks
Secondary Outcomes (3)
Time to resection
During the procedure
Number of forcep bites or snare attempts
During the procedure
Complications
4 weeks
Study Arms (2)
Cold forcep
EXPERIMENTALCold forcep polypectomy performed for polyps \<=3mm.
Cold snare
EXPERIMENTALCold forcep polypectomy performed for polyps \<=3mm.
Interventions
Removal of appropriate polyps using cold forceps until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.
Removal of appropriate polyps using cold snare until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.
Eligibility Criteria
You may qualify if:
- Patients 18 years or older
- Polyps \<=3mm
You may not qualify if:
- Pregnant
- Inflammatory bowel disease
- Polyposis syndromes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Veterans Affairs Palo Alto Health Care System
Palo Alto, California, 94304, United States
Related Publications (1)
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.
PMID: 35467557DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shai Friedland, MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Gastroenterology & Hepatology
Study Record Dates
First Submitted
September 9, 2020
First Posted
September 16, 2020
Study Start
September 16, 2020
Primary Completion
October 15, 2021
Study Completion
November 20, 2021
Last Updated
May 17, 2022
Record last verified: 2022-05