MS Versus NICE for Colorectal Lesions

Lyell McEwin Hospital348 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

348

Conditions

Colorectal Neoplasms Colorectal Polyp

Interventions

Modified Sano's classificationOTHER

Set of characteristics described by Singh et al. 2013 to evaluate colorectal lesions.

NICE classificationOTHER

Set of characteristics described by Hewett et al. 2012 to evaluate colorectal lesions.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: After two weeks of the colonoscopy

Secondary Outcomes

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)

Time frame: 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)

Time frame: Immediately after the colonoscopy (endoscopic) and 2 weeks after (histopathology)

Data from ClinicalTrials.gov

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