Systematic Wide-Field EMR Scar Assessment and Therapy Audit

Study Overview
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Brief Summary
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The development of a standardised imaging protocol to detect post endoscopic mucosal resection (EMR) recurrence or residual adenoma through the comparison of biopsies of the post EMR scar with endoscopic findings.

Detailed Description
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Removal of colonic polyps reduces colon cancer and although most polyps found are small, removal of large polyps can now be safely and effectively removed with wide field EMR. Residual polyp tissue is found at follow up colonoscopy in approximately 15% of cases however and remains a focus of attempts to improve EMR efficacy. All patients undergoing surveillance colonoscopy after EMR at Westmead Hospital Endoscopy unit will have steps of assessment and therapy of the scar recorded. Data will be entered into the large prospective audit database and also analysed separately. Data will be stored in coded format. The individual steps and the outcome of the scar interrogation and therapy will also be assessed and analysed. It is expected that these results will help guide the optimal approach to assessment and confirm the efficacy of therapy of recurrence further aiding the endoscopic approach to large colonic polyps.

Official Title
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Systematic Wide-Field EMR Scar Assessment and Therapy Audit

Conditions
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Polyps

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing surveillance colonoscopy of a previously resected large sessile colonic polyp or laterally spreading tumour ≥20mm in size. Age > 18 years Able to give informed consent to involvement in the clinical study Exclusion Criteria: Unable to provide informed consent for involvement

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EMR Surveillance<br>Patients who are referred for Endoscopic Mucosal Resection of Upper Gastrointestinal Lesions undertaking a surveillance visit will be included in this cohort. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of post-EMR recurrence | Presence of post-EMR recurrence | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological characteristics of post-EMR scar biopsies |  | one year | 
| Scar size | Scar size (maximum dimension) | one year | 
| Presence of post EMR scar with clip artifact | Presence of post EMR scar with clip artifact, recognized as one or more nodule within the scar with a normal pit pattern | one year | 
| Number of sites of recurrence | Number of sites of recurrence (unifocal, 2 sites, 3 or more sites) | one year | 
| Location of recurrence | Location of recurrence (edge of the scar, within the scar or both) | one year | 
| Morphology of recurrence | Morphology of recurrence (flat or elevated) | one year | 
| Kudo pit pattern assessment | Kudo pit pattern and whether the pit pattern of recurrence is only seen with NBI | one year | 
| NICE classification | As recurrence is diminutive the NICE classification is also applied and so the NBI appearance of recurrence (darker or lighter than the scar) is noted. | one year |