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

A novel endoscopic optical diagnosis classification system (SIMPLE) has recently been developed. This study aimed to evaluate the SIMPLE classification in a clinical cohort.  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.  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).  IEE with the SIMPLE classification achieved the quality benchmark for the resect and discard strategy; however, the NPV for rectosigmoid polyps requires improvement.