Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection of Colonic Polyps

Study Overview
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Brief Summary
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That Circumferential Submucosal Incision Endoscopic Mucosal Resection (CSI-EMR) will be at least as safe but more effective than conventional EMR for injection assisted EMR of large laterally spreading tumour and sessile polyps of the colon.

Detailed Description
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The investigators have recently developed a new, and the investigators believe safer and more effective technique for endoscopic mucosal resection (EMR). Utilising the new method the investigators make small cuts around the polyp to isolate it. Subsequently the Gelofusine solution is injected beneath the polyp and provides greater elevation. This allows us to improve the chance of removal of the entire polyp with one attempt in one piece. It is preferable to remove the polyp in one piece as it minimises the chance of leaving residual polyp tissue behind. Our team has recently completed an animal study comparing our newly developed technique to conventional EMR. The investigators have found significant improvements in our ability to completely remove the polyp in one attempt. There have also been recent studies overseas that have shown this new technique to be quite effective.

Official Title
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Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Resection for the Removal of Large Laterally Spreading Tumours and Sessile Polyps of the Colon

Conditions
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Colonic Polyps

Intervention / Treatment
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* Procedure: Circumferential Submucosal Incision Resection
* Procedure: Endoscopic Mucosal Resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Can give informed consent to trial participation Age greater than 18 Adenomas that have not have previously been attempted for resection (i.e. naïve lesions) Adenoma size greater than 20 mm Exclusion Criteria: Age less than 18 Previous resection or attempted resection of target adenoma lesion Pregnant patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Circumferential Submucosal Incision Resection<br> | Procedure: Circumferential Submucosal Incision Resection<br>* The patient is randomized, if in the active arm the procedure will continue as Circumferential Submucosal Incision Endoscopic Mucosal Resection.<br>|
| Active Comparator: Endoscopic Mucosal Resection<br>Patients randomised into this arm will receive the conventional treatment Endoscopic Mucosal Resection in which the sessile lesion is injected and snared by piecemeal technique. | Procedure: Endoscopic Mucosal Resection<br>* Patients randomised into this Intervention type will have Endoscopic Mucosal Resection performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of CSI EMR (Rates of en-bloc resection, recurrence rates) |  | 3 months |