Colorectal Neoplasms, Colorectal Polyp
Conditions
Keywords
colorectal polyp, colorectal lesion, Modified Sano's Classification, NICE classification, NBI, PIVI guidelines, SSA/P, sessile serrated adenoma, sessile serrated polyp
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.
Interventions
OTHERModified Sano's classification
Set of characteristics described by Singh et al. 2013 to evaluate colorectal lesions.
OTHERNICE classification
Set of characteristics described by Hewett et al. 2012 to evaluate colorectal lesions.
Sponsors
University of Adelaide
Lyell McEwin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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' 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 (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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Outcome results
None listed