Post-resection Treatment of Large Colon Polyps

Study Overview
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Brief Summary
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Patients who have provided informed consented and are scheduled to undergo endoscopic mucosal resection (EMR) of lesions 15mm and larger will be randomized to STSC (80 W, Effect 5) vs APC (preferred settings) vs No Treatment of the perimeter of the EMR site.

Detailed Description
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Data regarding polyp morphology, location & shape will be recorded in addition to procedure and treatment length. Injection fluid use and clipping will also be recorded in addition to any procedural complications. All randomized subjects will receive a 30-day post procedure follow-up phone call and be scheduled, as per the standard of care, to receive a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the rate of recurrence by endoscopic visualization of the EMR site at the first follow-up using endoscopic magnification and electronic chromoendoscopy, as well as systematic biopsy of the scars.

Official Title
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Prospective Randomized Controlled Trial Describing the Recurrence Rate of Adenomas in Sessile or Flat Colonic Lesions 15mm or Larger Receiving Post-resection Site Treatment With Snare Tip Soft Coagulation or Argon Plasma Coagulation

Conditions
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Recurrence

Intervention / Treatment
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* Device: Argon Plasma Coagulation
* Device: Snare Tip Soft Coagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 25 years and older Ability to provide informed consent Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion Exclusion Criteria: Pedunculated lesions Inflammatory bowel disease Inability to provide informed consent Lesions less than 15mm in largest dimension

Ages Eligible for Study
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Minimum Age: 25 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
Interventional Model Description: Patients will be randomized to Argon Plasma Coagulation vs Snare Tip Soft Coagulation vs no treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Argon Plasma Coagulation<br>Following polyp removal using standard of care methods, Argon Plasma Coagulation (APC) will be applied to the perimeter of the resection site before any clips are added. | Device: Argon Plasma Coagulation<br>* APC will be applied to the perimeter of the resection site<br>|
| Experimental: Snare Tip Soft Coagulation<br>Following polyp removal using standard of care methods, Snare Tip Soft Coagulation (STSC) will be applied to the perimeter of the resection site before any clips are added. | Device: Snare Tip Soft Coagulation<br>* STSC will be applied to the perimeter of the resection site<br>|
| No Intervention: No treatment<br>Following polyp removal using standard of care methods, neither APC nor STSC will be applied to the perimeter of the resection site. Clips may be added at the discretion of the PI. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time | The time it takes to apply each respective treatment (APC or STSC) on the day of procedure | 1 day | 
| Complications | To look at the number of complications for each randomization arm as assessed through a 30 day follow-up phone call | 1 day | 
| Cost analysis | Cost analysis detailing the effectiveness of the treatment versus the cost of each therapeutic device (argon probe vs. snare) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Argon Plasma Coagulation, Snare Tip Soft Coagulation, Recurrence rates