The CARMA Technique Study

Study Overview
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Brief Summary
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Colonoscopic removal of polyps is an important and well-established tool in the prevention of colorectal cancers. However, high polyp recurrence rates after endoscopic resection, with resultant development of interval cancers, remains a problem; this most commonly stems from unrecognised incomplete polyp resection. Thus, a standardised endoscopic technique is needed that will allow endoscopists to consistently achieve a clear margin of resection. The investigators believe the Cap Assisted Resection Margin Assessment (CARMA) technique will address this problem. This novel technique focuses on a standardised assessment of the resection margin after endoscopic polypectomy utilising available standard high-definition video endoscopes with imaging features including narrow band imaging (NBI) and magnification endoscopy.

Official Title
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The Cap-Assisted Resection Margin Assessment (CARMA) Technique After Polyp Resection: a Prospective Feasibility Study of a Novel Approach to Reduce Polyp Recurrence

Conditions
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Colonic Polyp, Colonic Sessile Serrated Lesion

Intervention / Treatment
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* Procedure: CARMA technique


Participation Criteria
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Eligibility Criteria
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Patients with colonic polyps will be considered following below criteria Inclusion Criteria: - any polypectomy (though only a maximum of two polyps from one individual participant) Exclusion Criteria: polyps less than 10mm which were resected under endoscopic view with a definite > 1mm clear margin scar site recurrence polyps polyps with endoscopic evidence of invasion pedunculated polyps pseudopolyps participants who will not be available for follow up endoscopy

Ages Eligible for Study
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Minimum Age: 16 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARMA Technique<br>All included participants undergo polyp resection using standard of care polypectomy techniques, followed by the CARMA technique | Procedure: CARMA technique<br>* Once standard polyp resection and assessment of the polypectomy site without magnification is completed, the CARMA technique will be applied. This will involve an assessment of the entire polypectomy margin using cap assisted magnification endoscopy with the ability to also use NBI (at the endoscopist's discretion) and documentation of any residual polyp noted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of achieving a clear resection margin using the CARMA technique |  | Established during index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the CARMA technique for residual polyp detection |  | Established during index procedure | 
| Frequency of residual polyp without CARMA assessment |  | Established during index procedure | 
| Incomplete resection rate with use of CARMA technique |  | Established during index procedure | 
| Incomplete resection rate with use of the CARMA technique in polyps > 10mm with hot snare |  | Established during index procedure | 
| Incomplete resection rate with use of the CARMA technique in polyps > 10mm with cold snare |  | Established during index procedure | 
| Residual polyp rate after CARMA technique with hot snare |  | Established during index procedure | 
| Residual polyp rate after CARMA technique with cold snare |  | Established during index procedure | 
| Time required for application of the CARMA technique with < 10mm |  | Established during index procedure | 
| Time required for application of the CARMA technique with > 10mm |  | Established during index procedure | 
| Polyp recurrence rate for < 10mm polyps |  | Established during surveillance procedure (following national guidelines - between 6 months to 5 years) | 
| Polyp recurrence rate for > 10mm polyps |  | Established during surveillance procedure (following national guidelines - between 6 months to 5 years) |