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Clinical validation of the SIMPLE classification for optical diagnosis of colorectal polyps.

ABSTRACT: Background and study aims A novel endoscopic optical diagnosis classification system (SIMPLE) has recently been developed. This study aimed to evaluate the SIMPLE classification in a clinical cohort. Patients and methods All diminutive and small colorectal polyps found in a cohort of individuals undergoing screening, diagnostic, or surveillance colonoscopies underwent optical diagnosis using image-enhanced endoscopy (IEE) and the SIMPLE classification. The primary outcome was the agreement of surveillance intervals determined by optical diagnosis compared with pathology-based results for diminutive polyps. Secondary outcomes included the negative predictive value (NPV) for rectosigmoid adenomas, the percentage of pathology exams avoided, and the percentage of immediate surveillance interval recommendations. Analysis of optical diagnosis for polyps ≤ 10 mm was also performed. Results 399 patients (median age 62.6 years; 55.6 % female) were enrolled. For patients with at least one polyp ≤ 5 mm undergoing optical diagnosis, agreement with pathology-based surveillance intervals was 93.5 % (95 % confidence interval [CI] 91.4-95.6). The NPV for rectosigmoid adenomas was 86.7 % (95 %CI 77.5-93.2). When using optical diagnosis, pathology analysis could be avoided in 61.5 % (95 %CI 56.9-66.2) of diminutive polyps, and post-colonoscopy surveillance intervals could be given immediately to 70.9 % (95 %CI 66.5-75.4) of patients. For patients with at least one ≤ 10 mm polyp, agreement with pathology-based surveillance intervals was 92.7 % (95 %CI 89.7-95.1). NPV for rectosigmoid adenomas ≤ 10 mm was 85.1 % (95 %CI CI 76.3-91.6). Conclusions IEE with the SIMPLE classification achieved the quality benchmark for the resect and discard strategy; however, the NPV for rectosigmoid polyps requires improvement.

SUBMITTER: Alaoui AA

PROVIDER: S-EPMC8062223 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background and study aims Correct optical diagnosis of colorectal polyps is crucial to implement a resect and discard strategy. Training methods have been proposed to reach recommended optical diagnosis thresholds. The aim of our study was to present a systematic review and meta-analysis on optical diagnosis training. Methods PubMed/Medline and Cochrane databases were searched between 1980 and October 2019 for studies reporting outcomes on optical diagnosis training of colorectal polyps. The primary outcome was optical diagnosis accuracy compared to histological analysis pre-training and post-training intervention. Subgroup analyses of experienced/trainee endoscopists, training methods, and small/diminutive polyps were included. Results Overall, 16 studies met inclusion criteria, analyzing the impact of training on 179 endoscopists. Pre-training accuracy was 70.3 % (6416/9131 correct diagnoses) whereas post-training accuracy was 81.6 % (7416/9213 correct diagnoses) (risk ratio [RR] 1.17; 95 % confidence interval [CI]: 1.09-1.24, P < 0.001). In experienced endoscopists, accuracy improved from 69.8 % (3771/5403 correct diagnoses) to 82.4 % (4521/5485 correct diagnoses) (RR 1.20; 95 % CI: 1.11-1.29, P < 0.001). Among trainees, accuracy improved from 69.6 % (2645/3803 correct diagnoses) to 78.8 % (2995/3803 correct diagnoses) (RR 1.14; 95 % CI 1.06-1.24, P < 0.001). In the small/diminutive polyp subgroup, accuracy improved from 68.1 % (3549/5214 correct diagnoses) to 77.1 % (4022/5214 correct diagnoses) in (RR 1.16 95 % CI 1.08-1.24 P < 0.001). On meta-regression analysis, the improvement in accuracy did not differ between computerized vs. didactic training approaches for experienced ( P = 0.792) and trainee endoscopists ( P = 0.312). Conclusions Optical diagnosis training is effective in improving accuracy of histology prediction in colorectal polyps. Didactic and computer-based training show comparable effectiveness in improving diagnostic accuracy.

Project description: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).

Project description:Adenomas and hyperplastic polyps are polypoid lesion and may occur at any location in the colon. At the present moment, all polyps should be resected endoscopically, although only adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. This approach enables the conduction of microscopic investigations of the lesions. By today, only the pathological diagnosis can distinguish exactly between adenomas and hyperplastic polyps. Some studies have investigated the value of the socalled optical biopsy method. Optical biopsy means the visual assessment of the polyp and the determination of a diagnosis solely on behalf of optical criteria. This method is conducted in real time during colonoscopy. If it can be shown, that endoscopist using optical biopsy are able to predict histopathological diagnoses of colonic polyps sufficiently this would possibly lead to simplification of diagnostic procedures. For instance, it would be conceivable to resect hyperplastic polyps and small adenomas and discard them without further assessment by a pathologist. Gastroenterological societies demand for a 90 percent accordance between diagnoses set by endoscopists and pathologists as a prerequisite for the implementation of the optical biopsy method. In this study we want to proof that the use of a new narrow-band imaging (NBI) tool (Exera III, Olmpus) is capable to rise accuracy of optically ascertained diagnoses of colonic polyps. NBI is a light filter tool which can be activated by pressing a button at the endoscope. NBI function leads to an endoscopic picture which appears blue and enables endoscopists to better assess surface structures and vascular patterns. In a prospective randomised multicenter setting we plan to conduct colonoscopy in 380 patients. Half of the patients will be examined without use of NBI (control arm). In these cases colonoscopists will assess optical diagnosis of polyps without turning on the NBI tool. If polyps are detected in patients belonging to the intervention arm NBI will be used and optical diagnosis will be determined using the NICE (NBI International Colorectal Endoscopic) classification. All polyps will be resected and send to pathology for further microscopic assessment. After completing the trial we aim to compare accuracy of the optical diagnosis in both groups. Our hypothesis is, that by using the new NBI tool accuracy (accordance between optical and histopathological diagnosis) can be increased from 78% to 90%.

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Clinical validation of the SIMPLE classification for optical diagnosis of colorectal polyps.

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