MS Versus NICE for Colorectal Lesions

Study Overview
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Brief Summary
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OBJECTIVE: Our study aimed to compare a recently-developed endoscopic classification with an established one for colorectal lesions in a randomised trial between 2013 and 2015.

Detailed Description
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OBJECTIVE: Current practice requires histopathological assessment to confirm diagnosis for colorectal lesions detected at colonoscopy. Advances in endoscopic imaging contribute for real-time diagnosis which, apart from being cost and time-saving, also guides decision-making and reduces risks. Our study aimed to compare a recently-developed endoscopic classification with an established one. DESIGN: The modified Sano's classification (MS) was compared to the Narrow Band Imaging (NBI) International Colorectal Endoscopic classification (NICE) in a randomised trial between 2013 and 2015. An experimented endoscopist classified each polyp, what was compared to histopathology.

Official Title
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Prospective Randomised Study Comparing Modified Sano's (MS) Classification and NBI International Colorectal Endoscopic (NICE) for Differentiating Colorectal Lesions

Conditions
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Colorectal Neoplasms, Colorectal Polyp

Intervention / Treatment
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* Other: Modified Sano's classification
* Other: NICE classification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted in the Endoscopy Unit for a colonoscopy Patients over 18 years-old Patients or their caregivers that have understanding of the procedure and that have signed the consent form for the study Exclusion Criteria: Patients without colorectal polyps Patients with poor bowel preparation Patients that do not agree with or withdraw the consent form

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Sano's Classification<br>Modified Sano's Classification as described by Singh et al. 2013 | Other: Modified Sano's classification<br>* Set of characteristics described by Singh et al. 2013 to evaluate colorectal lesions.<br>* Other names: MS classification;|
| Active Comparator: NICE classification<br>NBI International Colorectal Endoscopic Classification as described by Hewett et al. 2012 | Other: NICE classification<br>* Set of characteristics described by Hewett et al. 2012 to evaluate colorectal lesions.<br>* Other names: NBI International Colorectal Endoscopic Classification;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (neoplastic versus non-neoplastic) | Comparison of NICE or MS with the final histopathology in regards to polyps' subtype (i.e. non-neoplastic = Hyperplastic Polyp (HP) and neoplastic = Sessile Serrated Adenoma/Polyp (SSA/P), Adenomatous Polyp (AP), Traditional Serrated Adenoma (TSA), superficial cancer and invasive cancer) | After two weeks of the colonoscopy | 
| Accuracy measures in comparison to the final histopathology in regards to polyps' invasiveness | Comparison of NICE or MS with the final histopathology in regards to invasiveness (SSA/P, AP, TSA or superficial cancer versus invasive cancer) | After two weeks of the colonoscopy | 
| Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (SSA/P versus non-SSA/P) | Comparison of MS with the final histopathology in regards to SSA/P (SSA/P versus non-SSA/P) | After two weeks of the colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy in regards to negative predictive value of diminutive distal colorectal polyps | Comparison of NICE or MS with the final histopathology in regards to <5 mm distal to the sigmoid polyps (NPV for HPs - according to the PIVI guidelines) | After two weeks of the colonoscopy | 
| Agreement in predicting post-colonoscopy surveillance interval with final histopathology | Comparison of NICE or MS with the final histopathology in regards to prediction of surveillance interval (according to the PIVI guidelines) | Immediately after the colonoscopy (endoscopic) and 2 weeks after (histopathology) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NBI, colorectal polyp, colorectal lesion, Modified Sano's Classification, NICE classification, PIVI guidelines, SSA/P, sessile serrated adenoma, sessile serrated polyp