Quad Resection (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)
A Randomized Trial Comparing the Effectiveness of Polyp Resection Treatments (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)
1 other identifier
interventional
238
1 country
1
Brief Summary
The study will compare the use of cold snare, hot snare, cold EMR, and hot EMR for polyp resection. Although previous studies have compared two of the potential resection methods, no previous study has evaluated all four of the resection methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 6, 2018
CompletedFirst Submitted
Initial submission to the registry
March 6, 2018
CompletedFirst Posted
Study publicly available on registry
March 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2021
CompletedResults Posted
Study results publicly available
February 15, 2023
CompletedFebruary 15, 2023
February 1, 2023
3.3 years
March 6, 2018
May 9, 2022
February 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy of Resection (Central Post-Resection Biopsies)
Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the central post-resection biopsies. Positive means that there was residual polyp tissue seen on the central post-resection biopsies. Negative central post-resection biopsies are considered a better outcome.
1 day
Efficacy of Resection (Peripheral Post-Resection Biopsies)
Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the peripheral post-resection biopsies. Positive means that there was residual polyp tissue seen on the peripheral post-resection biopsies. Negative peripheral post-resection biopsies are considered a better outcome.
1 day
Study Arms (4)
Cold Snare
EXPERIMENTALPolyps sized 6mm to 15mm found during colonoscopy will be removed using cold snare techniques.
Hot Snare
EXPERIMENTALPolyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques.
Cold EMR
EXPERIMENTALPolyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques.
Hot EMR
EXPERIMENTALPolyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques.
Interventions
Subjects randomized to Cold Snare Intervention will have any polyps sized 6mm to 15mm removed using cold snare techniques (no electrocautery, no submucosal injection.)
Subjects randomized to Hot Snare Intervention will have any polyps sized 6mm to 15mm removed using hot snare techniques (with electrocautery, no submucosal injection.)
Subjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.)
Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.)
Eligibility Criteria
You may qualify if:
- Aged 40 years or older
- Ability to provide informed consent
You may not qualify if:
- Subjects with a history of Inflammatory Bowel Disease
- Lesions less than 6mm or greater than 15mm in largest dimension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- John D. Dingell VA Medical Centercollaborator
- White River Junction Veterans Affairs Medical Centercollaborator
Study Sites (1)
Indiana University
Indianapolis, Indiana, 46202, United States
Related Publications (1)
Rex DK, Anderson JC, Pohl H, Lahr RE, Judd S, Antaki F, Lilley K, Castelluccio PF, Vemulapalli KC. Cold versus hot snare resection with or without submucosal injection of 6- to 15-mm colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2022 Aug;96(2):330-338. doi: 10.1016/j.gie.2022.03.006. Epub 2022 Mar 12.
PMID: 35288147DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study endoscopists are experts with special interest in polypectomy; serrated lesions were included in the study instead of only including adenomas; incomplete resections occurred in 10-15mm lesions so a study designed for 10-15mm or 10-20mm lesions may be more relevant; potential of proceduralist bias due to lack of endoscopist blinding; relying on biopsies of the defect instead of evaluation of scars at surveillance for determining efficacy
Results Point of Contact
- Title
- Clinical Research Specialist
- Organization
- Indiana University
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas K Rex, MD
Indiana University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
March 6, 2018
First Posted
March 12, 2018
Study Start
February 6, 2018
Primary Completion
May 14, 2021
Study Completion
May 14, 2021
Last Updated
February 15, 2023
Results First Posted
February 15, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share
De-identified data may be shared in the future upon request per PI discretion.