MS Versus NICE for Colorectal Lesions

Not Applicable

Completed

• Conditions: Colorectal Polyp; Colorectal Neoplasms
• Interventions: Other: Modified Sano's classification; Other: NICE classification

• Registration Number: NCT02963207
• Lead Sponsor: Lyell McEwin Hospital

Brief Summary

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

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 Timeline

• Study Start: 2013-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-11
• Study First Submitted: 2016-11-06
• Study First Submitted QC: 2016-11-09
• Last Update Submitted: 2016-11-09
• Study First Posted: 2016-11-15
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 348

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Sano's Classification	Modified Sano's classification	Modified Sano's Classification as described by Singh et al. 2013
NICE classification	NICE classification	NBI International Colorectal Endoscopic Classification as described by Hewett et al. 2012

Primary Outcome Measures

Name	Time	Method
Accuracy measures in comparison to the final histopathology in regards to polyps' invasiveness	After two weeks of the colonoscopy	Comparison of NICE or MS with the final histopathology in regards to invasiveness (SSA/P, AP, TSA or superficial cancer versus invasive cancer)
Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (neoplastic versus non-neoplastic)	After two weeks of the colonoscopy	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)
Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (SSA/P versus non-SSA/P)	After two weeks of the colonoscopy	Comparison of MS with the final histopathology in regards to SSA/P (SSA/P versus non-SSA/P)

Secondary Outcome Measures

Name	Time	Method
Accuracy in regards to negative predictive value of diminutive distal colorectal polyps	After two weeks of the colonoscopy	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)
Agreement in predicting post-colonoscopy surveillance interval with final histopathology	Immediately after the colonoscopy (endoscopic) and 2 weeks after (histopathology)	Comparison of NICE or MS with the final histopathology in regards to prediction of surveillance interval (according to the PIVI guidelines)