Colorectal Neoplasms, Colorectal Polyp
Conditions
Brief summary
Optical diagnosis of colorectal polyps is a promising tool to avoid risks of unnecessary polypectomies and to save costs of tissue pathology. NICE (NBI International Colorectal Endoscopic) and WASP (Workgroup on Serrated Polyps and Polyposis) classification were developed for diagnosis of adenomatous and sessile serrated polyps, respectively.
Detailed description
Near-focus (NF) narrow-band imaging (NBI) is an image-magnifying technology which enables optical magnification of up to 65x in near focus (NF) compared with 52x in normal standard focus (SF) with the simple push of a button of the endoscope to be interchangeable between NF and SF. There were few studies comparing diagnostic accuracy between NF and SF in the diagnosis of colorectal polyps. So, our aim of the current study is to compare accuracy of NF NBI compared with SF NBI in the optical diagnosis of neoplastic and non-neoplastic polyp and the accuracy of NF NBI versus SF NBI in distinguishing serrated adenoma from hyperplastic polyp in sessile lesions using histologic evaluation as the gold standard.
Interventions
DIAGNOSTIC_TESTNear Focus NBI
Colonoscopy with near focus narrowing band imaging technology . Optical specifications include a 2 mm near field focal depth. Optical diagnosis of polyps were according to NICE and WASP, respectively.
DIAGNOSTIC_TESTStandard Focus NBI
Colonoscopy with narrow band imaging technology.Optical diagnosis of polyps were according to NICE and WASP, respectively.
Sponsors
Prince of Songkla University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who were scheduled for colonoscopy at NKC institute
Exclusion criteria
* Inflammatory bowel disease * Polyposis syndrome * Colorectal cancer * Active gastrointestinal bleeding * Pregnant woman * Inadequate bowel preparation * Contraindication for polyps removal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of accurate polyp histology predictions by the Endoscopists in the two groups. | At the time of procedure | Measure of the percentage of accurate predictions by the endoscopists in the differentiation of neoplastic from non neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without near focus features |
| Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups. | At the time of procedure | Measure of the percentage od accurate predictions by the endoscopists in the differentiation of sessile serrated polyps/adenoma from hyperplastic polyps, using the high definition NBI colonoscopy with and without near focus features. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The polyp detection rate | At the time of procedure | The prevalence of patients with at least one polyp was detected |
| The adenoma detection rate | At the time of procedure | The prevalence of patients with at least one adenoma was detected |
| Diagnostic Characteristics | At the time of procedure | Compare the diagnostic characteristic (sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without near focus features. |
Countries
Thailand
Outcome results
None listed