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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Trial Comparing the Effectiveness of Polyp Resection Treatments (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)

Conditions
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Colon Cancer, Colon Polyp, Colon Adenoma

Intervention / Treatment
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* Procedure: Cold Snare
* Procedure: Hot Snare
* Procedure: Cold EMR
* Procedure: Hot EMR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 40 years or older Ability to provide informed consent Exclusion Criteria: Subjects with a history of Inflammatory Bowel Disease Lesions less than 6mm or greater than 15mm in largest dimension

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold Snare<br>Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold snare techniques. | Procedure: Cold Snare<br>* Subjects randomized to Cold Snare Intervention will have any polyps sized 6mm to 15mm removed using cold snare techniques (no electrocautery, no submucosal injection.)<br>|
| Experimental: Hot Snare<br>Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques. | Procedure: Hot Snare<br>* Subjects randomized to Hot Snare Intervention will have any polyps sized 6mm to 15mm removed using hot snare techniques (with electrocautery, no submucosal injection.)<br>|
| Experimental: Cold EMR<br>Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques. | Procedure: Cold EMR<br>* Subjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.)<br>|
| Experimental: Hot EMR<br>Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques. | Procedure: Hot EMR<br>* Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyp Resection, Cold Snare, Hot Snare, Cold Endoscopic Mucosal Resection (EMR), Hot Endoscopic Mucosal Resection (EMR), Colonoscopy