Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia

Study Overview
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Brief Summary
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The investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. The investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors.

Detailed Description
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The primary aim of the study is to compare the efficacy, efficiency and safety of two types of snares used in Endoscopic Mucosal Resection (EMR), a combined needle and snare unit (ISnare, US Endoscopy) versus an oval braided snare with spiral wire (Snaremaster, Olympus). The secondary aim is to explore whether EMR efficacy and efficiency is depended upon the injection solution used, saline versus Gonak (a solution containing HPMC, saline, and epinephrine) for EMR.

Official Title
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Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia: A Randomized Prospective Comparison of Snares and Injectate in the Resection of Large Sessile Colonic Polyps

Conditions
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Neoplasms, Gastric Cancer

Intervention / Treatment
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* Procedure: Standard of Care Procedure as described in ARM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sessile colorectal polyp laterally spreading lesions as defined by Paris Classification type II and > 1 cm or greater Exclusion Criteria: Those with ulcerated depressed lesions (Paris type III) or biopsy proven invasive carcinoma Inflammatory bowel disease patients Coagulopathy ( INR> 1.5) that cannot be corrected

Ages Eligible for Study
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Minimum Age: 18 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iSnare with Gonak solution<br> | Procedure: Standard of Care Procedure as described in ARM<br>* Standard of Care Procedure as described in ARM<br>|
| Experimental: Snaremaster braided snare with Gonak solution<br> | Procedure: Standard of Care Procedure as described in ARM<br>* Standard of Care Procedure as described in ARM<br>|
| Experimental: iSnare with saline solution<br> | Procedure: Standard of Care Procedure as described in ARM<br>* Standard of Care Procedure as described in ARM<br>|
| Experimental: Snaremaster braided snare with saline solution<br> | Procedure: Standard of Care Procedure as described in ARM<br>* Standard of Care Procedure as described in ARM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Two Devices used in EMR | To explore the efficacy of two devices used in EMR (iSnare® system versus Snaremaster) as measured by the Sydney Resection Quotient (SRQ). SRQ is defined as lesion size in mm divided by the number of pieces to resect . | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the Use of Two Injectates | To compare the use of two injectates (saline versus HPMC mixture) with respect to efficacy as measured by the aforementioned SRQ. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sessile neoplasms, flat neoplasms, gastric cancer