Narrow band imaging optical diagnosis of small colorectal polyps in routine clinical practice: the Detect Inspect Characterise Resect and Discard 2 (DISCARD 2) study.
Accurate optical characterisation and removal of small adenomas (<10 mm) at colonoscopy would allow hyperplastic polyps to be left in situ and surveillance intervals to be determined without the need for histopathology. Although accurate in specialist practice the performance of narrow band imaging (NBI), colonoscopy in routine clinical practice is poorly understood.
NBI-assisted optical diagnosis was compared with reference standard histopathological findings in a prospective, blinded study, which recruited adults undergoing routine colonoscopy in six general hospitals in the UK. Participating colonoscopists (N=28) were trained using the NBI International Colorectal Endoscopic (NICE) classification (relating to colour, vessel structure and surface pattern). By comparing the optical and histological findings in patients with only small polyps, test sensitivity was determined at the patient level using two thresholds: presence of adenoma and need for surveillance. Accuracy of identifying adenomatous polyps <10 mm was compared at the polyp level using hierarchical models, allowing determinants of accuracy to be explored.
Of 1688 patients recruited, 722 (42.8%) had polyps <10 mm with 567 (78.5%) having only polyps <10 mm. Test sensitivity (presence of adenoma, N=499 patients) by NBI optical diagnosis was 83.4% (95% CI 79.6% to 86.9%), significantly less than the 95% sensitivity (p<0.001) this study was powered to detect. Test sensitivity (need for surveillance) was 73.0% (95% CI 66.5% to 79.9%). Analysed at the polyp level, test sensitivity (presence of adenoma, N=1620 polyps) was 76.1% (95% CI 72.8% to 79.1%). In fully adjusted analyses, test sensitivity was 99.4% (95% CI 98.2% to 99.8%) if two or more NICE adenoma characteristics were identified. Neither colonoscopist expertise, confidence in diagnosis nor use of high definition colonoscopy independently improved test accuracy.
This large multicentre study demonstrates that NBI optical diagnosis cannot currently be recommended for application in routine clinical practice. Further work is required to evaluate whether variation in test accuracy is related to polyp characteristics or colonoscopist training.
The study was registered with clinicaltrials.gov (NCT01603927).
Rees CJ
,Rajasekhar PT
,Wilson A
,Close H
,Rutter MD
,Saunders BP
,East JE
,Maier R
,Moorghen M
,Muhammad U
,Hancock H
,Jayaprakash A
,MacDonald C
,Ramadas A
,Dhar A
,Mason JM
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Real-Time Characterization of Diminutive Colorectal Polyp Histology Using Narrow-Band Imaging: Implications for the Resect and Discard Strategy.
Narrow-band imaging (NBI) allows real-time histologic classification of colorectal polyps. We investigated whether endoscopists without prior training in NBI can achieve the following thresholds recommended by the American Society for Gastrointestinal Endoscopy: for diminutive colorectal polyps characterized with high confidence, a ≥90% negative predictive value for adenomas in the rectosigmoid and a ≥90% agreement in surveillance intervals.
Twenty-six endoscopists from 2 tertiary care centers underwent standardized training in NBI interpretation. Endoscopists made real-time predictions of diminutive colorectal polyp histology and surveillance interval predictions based on NBI. Their performance was evaluated by comparing predicted with actual findings from histologic analysis. Multilevel logistic regression was used to assess predictors of performance. Cumulative summation analysis was used to characterize learning curves.
The endoscopists performed 1451 colonoscopies and made 3012 diminutive polyp predictions (74.3% high confidence) using NBI. They made 898 immediate post-procedure surveillance interval predictions. An additional 505 surveillance intervals were determined with histology input. The overall negative predictive value for high-confidence characterizations in the rectosigmoid was 94.7% (95% confidence interval: 92.6%-96.8%) and the surveillance interval agreement was 91.2% (95% confidence interval: 89.7%-92.7%). Overall, 97.0% of surveillance interval predictions would have brought patients back on time or early. High-confidence characterization was the strongest predictor of accuracy (odds ratio = 3.42; 95% confidence interval: 2.72-4.29; P < .001). Performance improved over time, however, according to cumulative summation analysis, only 7 participants (26.9%) identified adenomas with sufficient sensitivity such that further auditing is not required.
With standardized training, gastroenterologists without prior expertise in NBI were able to meet the negative predictive value and surveillance interval thresholds set forth by the American Society for Gastrointestinal Endoscopy. The majority of disagreement in surveillance interval brought patients back early. Performance improves with time, but most endoscopists will require ongoing auditing of performance. ClinicalTrials.gov ID NCT02441998.
Patel SG
,Schoenfeld P
,Kim HM
,Ward EK
,Bansal A
,Kim Y
,Hosford L
,Myers A
,Foster S
,Craft J
,Shopinski S
,Wilson RH
,Ahnen DJ
,Rastogi A
,Wani S
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Narrow-band Imaging International Colorectal Endoscopic Classification to predict polyp histology: REDEFINE study (with videos).
The Narrow-band Imaging International Colorectal Endoscopic (NICE) Classification has been validated for differentiating hyperplastic from adenomatous polyps. This classification system was based on narrow-band imaging (NBI) technology, leaving uncertainty regarding its applicability to other systems. The aim of this study was to assess accuracy and reliability of histologic predictions for polyps <1 cm by applying the NICE classification to the Fujinon Spectral Imaging Color Enhancement (FICE) System.
A video library of 55 polyps <1 cm histologically verified with FICE was prospectively created, including polyps that fulfilled inclusion criteria (morphology, size, histology) in consecutive colonoscopies. Six endoscopists with experience in electronic chromoendoscopy independently reviewed the polyp images, scored the polyps as adenomatous or hyperplastic, and assigned a level of confidence to the predictions. Twenty videos were reassessed at 6 months. The diagnostic performances of the endoscopists was calculated both combined and individually according to the histopathology of the polyps. A mixed-effect logistic regression model, in which polyps were considered as random effects, and polyp histology, confidence level, and readers were considered as fixed effects, was used. Results were expressed as odds ratios (ORs) with 95% confidence intervals (CIs).
Of the 55 polyps (mean size 4.6 mm), 29 (53%) were adenomas, and 26 (47%) were hyperplastic. Across all the readers and observations, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and area under the curve (AUC) were 77%, 75%, 88%, 75%, 77%, and 0.82, respectively. Individual rater accuracy ranged from 66% to 96%, being <90% in 5 of 6 cases. Overall, 68.5% of predictions (226/330) were made with high confidence, although there was high variability (Fleiss kappa, 0.15; 95% CI, 0.08-0.22). Sensitivity, specificity, PPV, NPV, accuracy, and AUC for predictions made with high confidence were 81%, 80.5%, 80%, 77%, 82%, and 0.88 being significantly more accurate as compared with a low confidence of diagnosis (OR 2.4; 95% CI, 1.2-4.7). Regarding the performance of the individual NICE criteria, the odds of adenoma detection were 3.4 (95% CI, 1.8-6.3) and 4.0 (95% CI, 2.1-7.5) by using surface and vessels patterns alone, as compared with the color criterion. Interrater and intrarater agreement with the NICE was only moderate (interrater: Fleiss kappa, 0.51; 95% CI, 0.44-0.56; intrarater: kappa, 0.40; 95% CI, 0.20-0.60).
The application of the NICE classification to FICE resulted in suboptimal accuracy and only moderate interobserver agreement.
Repici A
,Ciscato C
,Correale L
,Bisschops R
,Bhandari P
,Dekker E
,Pech O
,Radaelli F
,Hassan C
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