Clinical trial NCT02963207: MS Versus NICE for Colorectal Lesions
Official title: Prospective Randomised Study Comparing Modified Sano's (MS) Classification and NBI International Colorectal Endoscopic (NICE) for Differentiating Colorectal Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Colorectal Polyp
Keywords: colorectal polyp
colorectal lesion
Modified Sano's Classification
NICE classification
NBI
PIVI guidelines
SSA/P
sessile serrated adenoma
sessile serrated polyp
Lead sponsor: Lyell McEwin Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Adelaide
First posted: 2016-11-15
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (neoplastic versus non-neoplastic)
timeFrame: After two weeks of the colonoscopy
measure: Accuracy measures in comparison to the final histopathology in regards to polyps' invasiveness
timeFrame: After two weeks of the colonoscopy
measure: Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (SSA/P versus non-SSA/P)
timeFrame: After two weeks of the colonoscopy
Secondary outcomes:
measure: Accuracy in regards to negative predictive value of diminutive distal colorectal polyps
timeFrame: After two weeks of the colonoscopy
measure: Agreement in predicting post-colonoscopy surveillance interval with final histopathology
timeFrame: Immediately after the colonoscopy (endoscopic) and 2 weeks after (histopathology)
Other outcomes:
Locations:
Study officials:
affiliation: The Lyell McEwin and The University of Adelaide
name: Leonardo ZC Pu, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh R, Jayanna M, Navadgi S, Ruszkiewicz A, Saito Y, Uedo N. Narrow-band imaging with dual focus magnification in differentiating colorectal neoplasia. Dig Endosc. 2013 May;25 Suppl 2:16-20. doi: 10.1111/den.12075.
citation: Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.