The Non-Optical Resect and Discard Study (NORD)

Study Overview
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Brief Summary
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Eliminating the need for conventional histopathological assessment of diminutive colon polyps - The Non-Optical Resect and Discard (NORD) study

Detailed Description
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Implementation of this approach by community-based gastroenterologists has failed to reach the required quality benchmarks and studies evaluating optical biopsy have not shown diagnostic test performance results that meet standards set by society guidelines in order to promote its widespread clinical adoption. Optical polyp diagnosis and the current resect and discard approach are too complex for clinical adoption. Thus, clinical implementation of this valuable concept has not been achieved to date and its cost-saving potential has not been realized. In order to effectively operationalize a resect and discard strategy, one must find a different way to distinguish neoplastic from non-neoplastic polyps. There exist differences in the proportion of polyps found to be adenomatous in the left and right colon. One recent study reported that 30% of left-sided polyps and 76% of right-sided polyps were found to be adenomas on histology. Since polyps located in the proximal colon are more likely to be adenomas and polyps in the recto-sigmoid colon are more likely hyperplastic we hypothesized that a model based on polyp location might be able to replace optical biopsy and histopathology. Such an approach would be very simple to adopt by every clinician and would allow for easy adoption into clinical practice.

Official Title
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Eliminating the Need for Conventional Histopathological Assessment of Diminutive Colon Polyps - The Non-Optical Resect and Discard Study (NORD)

Conditions
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Polyp of Colon

Intervention / Treatment
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* Diagnostic Test: iScan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent form Age 45 to 80 years Indication for full colonoscopy Exclusion Criteria: Known inflammatory bowel disease Active colitis Coagulopathy Familial polyposis syndrome Poor general health defined as an ASA class > 3 Emergency colonoscopies.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 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

| Intervention/Treatment |
| --- |
|Diagnostic Test: iScan|this instrument provides extra confidence for in vivo diagnosis through improved vessel and mucosal pattern characterization.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine concordance with the pathology-based surveillance recommendation of two new resect and discard models | Our aim is to examine and to make a comparison of these models with the currently endorsed resect and discard approach that is based on optical polyp diagnosis and we will also obtain histopathology for all polyps as a reference gold-standard to which all models are compared. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess for how many patients each model will theoretically reduce the need for histopathologic assessment and follow-up consultations to discuss pathology results and surveillance interval recommendations | Assess for how many patients each model will theoretically reduce the need for histopathologic assessment and follow-up consultations to discuss pathology results and surveillance interval recommendations | 24 months | 
| Re-evaluate classical optical biopsy criteria (NICE and SANO classifications) | We will assess this in conjunction with different digital chromoendoscopy methods (NBI, iScan and Optivista) and assess concordance between these imaging methods and classification systems to differentiate neoplastic from non-neoplastic polyps. | 24 months | 
| Assess which factors are associated with accuracy and negative predictive value (NPV) of optical polyp diagnosis | Assess which factors are associated with accuracy and negative predictive value (NPV) of optical polyp diagnosis | 24 months | 
| Evaluate Polyp-Based Resect and Discard model | Surveillance interval agreement of the PBRD strategy compared with pathology-based management according to the 2020 USMSTF guidelines. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyp resection, Colorectal cancer