Quad Resection (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)

Not Applicable

Completed

• Conditions: Colon Polyp; Colon Cancer; Colon Adenoma
• Interventions: Procedure: Cold Snare; Procedure: Hot EMR; Procedure: Hot Snare; Procedure: Cold EMR

• Registration Number: NCT03462706
• Lead Sponsor: Indiana University

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.

Detailed Description

The optimal method for removal of polyps 6-9 and 10-15 mm in size is not established. In this study, we propose to evaluate four different treatments for polyps (sized 6mm-15mm). The four treatments are cold snaring without injection, hot snaring without injection, cold EMR, and hot EMR. This study aims to help to establish the optimal resection technique for 6-9 and 10-15 mm polyps.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-02-06
• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-12
• Primary Completion: 2021-05-14
• Study Completion: 2021-05-14
• Results First Submitted: 2022-05-09
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Results First Posted: 2023-02-15
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

• Aged 40 years or older
• Ability to provide informed consent

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Exclusion Criteria

• Subjects with a history of Inflammatory Bowel Disease
• Lesions less than 6mm or greater than 15mm in largest dimension

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold Snare	Cold Snare	Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold snare techniques.
Hot EMR	Hot EMR	Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques.
Hot Snare	Hot Snare	Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques.
Cold EMR	Cold EMR	Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques.

Primary Outcome Measures

Name	Time	Method
Efficacy of Resection (Central Post-Resection Biopsies)	1 day	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.
Efficacy of Resection (Peripheral Post-Resection Biopsies)	1 day	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.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States