Validation of the NICE Classification Using Pentax Chromoendoscopy
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|ClinicalTrials.gov Identifier: NCT03155308|
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment|
|Colorectal Polyp||Device: Pentax chromoendoscopy (i-scan and Optical Enhancement)|
|Study Type :||Observational|
|Actual Enrollment :||95 participants|
|Official Title:||Validation of the NICE Classification Using Pentax Chromoendoscopy (I-scan and Optical Enhancement System|
|Actual Study Start Date :||April 1, 2017|
|Actual Primary Completion Date :||May 1, 2018|
|Actual Study Completion Date :||July 1, 2018|
Consecutive adult patients between 18 and 80 years of age, referred for elective outpatient colonoscopy and in whom polypectomy or biopsy is perform will be enrolled to be evaluated using Pentax chromoendoscopy (i-scan and Optical Enhancement)
Device: Pentax chromoendoscopy (i-scan and Optical Enhancement)
All lesions will be evaluated using the 3 i-scan modes and the 2 OE modes without magnification. The lesion size data, location and macroscopic shape of the lesions based on the Paris classification will be recorded. Finally all lesions will be classified in real-time into 3 types based on NICE classification (NICE 1, hyperplastic polyps; NICE 2, adenoma and superficial submucosal carcinoma; NICE 3, SM-d invasive carcinoma). A level of confidence (high or low) will be assign in each stage. Polyp's images will be photographically and videotape recorded. All polyps will be resected or biopsied for histopathological examination used as the criterion standard for the analysis.
- Diagnostic accuracy of Pentax chromoendoscopy (i-scan and Optical Enhancement system) for differentiating between the three types of NICE classification. [ Time Frame: 4 month ]colorectal polypoid lesions will be evaluated using Pentax chromoendoscopy (i-scan and OE system) in order to classified the lesions by NICE classification. The histopathology will be evaluated from all lesions as Gold Standard and finally accuracy, sensitivity, specificity, positive predictive value and negative predictive value will be calculated.
- assessment of inter- and intra-observer agreement [ Time Frame: 4 month ]A data set containing 30 random-selected videos will be presented after 2 months to the three main investigators (C.R.M, M.V, M.S.A.) in order to assess intra and inter-observer reproducibility. The endoscopists will have classified again the polyps according to the three types on the NICE classification. To examine inter and intra observer agreement, kappa values will be calculated. Kappa coefficients below 0.4 indicate "poor agreement," values between 0.4 and 0.8 represent "moderate to good agreement," and values greater than 0.8 indicate "excellent agreement."
- Diagnostic accuracy of the individual criteria of NICE classification using i-scan and OE system. [ Time Frame: 4 month ]It will be calculated the accuracy, sensitivity, specificity, negative and positive predictive values with the 95% of Confidence Interval (95% CI), for each component of the classification and for the overall prediction by using the classification. Using multilevel logistic regression, the sensitivity and specificity of the different criteria, will be compared. Diagnostic values of the criteria used in combination (combination of "at least 1 criterion being positive" versus "all combined criteria being positive") will be assessed and compared. The criterion standard for validation of predictions will be the lesions histology. Presence of adenomatous feature at each criterion will be defined as a positive result.
- Diagnostic accuracy according to the level of confidence. [ Time Frame: 4 month ]A level of confidence (high or low) will be assign in each stage. A high confidence prediction will be considered when the endoscopist is 90% certain of the diagnosis and this condition will be consider when polyps have ≥1 features associated with one NICE type and no features associated to the others NICE type. If there are uncertainty regarding the features or if there are features from different NICE types the prediction will have low confidence.
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155308
|Ecuadorian Institute of Digestive Diseases, Omnihospital|
|Guayaquil, Guayas, Ecuador, 090505|
|Principal Investigator:||Carlos A Robles-Madranda, MD||Ecuadorian Institute of Digestive Diseases|