Background Image enhanced endoscopy (IEE) allows for real-time optical diagnosis of colorectal polyps in order to replace histopathology. A novel classification system (SIMPLE classification) has recently been developed for optical diagnosis when using the novel Pentax Optivista IEE platform. Aims The aim of this study was to evaluate the SIMPLE classification for optical polyp diagnosis in a prospective clinical study. Methods Patients undergoing screening, diagnostic or surveillance colonoscopies were enrolled in the study. All colorectal polyps 1-10mm found underwent optical polyp diagnosis using the SIMPLE classification with either iScan or Optivista for image-enhanced endoscopy (IEE). Polyps were resected as per standard care and sent for histopathology analysis. Optical diagnosis and surveillance intervals were calculated based on SIMPLE criteria and compared to pathology-based results as reference. Primary outcome was the agreement of the surveillance intervals based on the SIMPLE classification with pathology-based surveillance intervals for 1-5mm colorectal polyps. Secondary outcomes included negative predictive value (NPV) for rectosigmoid adenoma, percentage of pathology avoided, percentage of post-colonoscopy immediate recommendations, and surveillance interval agreement, rectosigmoid NPV for 1-10mm polyps. Results 399 patients (mean age: 62.4, 55.6% female) with 278 diminutive and 364 small polyps were evaluated in the study cohort. For ≤5mm polyps, agreement with pathology-based surveillance intervals was 93.5% [95% CI 91.1–95.9] (shorter: 4.5% [95% CI 2.5–6.5]; longer: 1.8% [95% CI 0.5–3.0]). NPV for rectosigmoid adenomatous polyps (including SSA) was 85.5% [95% CI 77.6–93.4]. Using Optical diagnosis and the SIMPLE classification, pathology analysis could be avoided in 61.5% [95% CI 56.9–66.2] of polyps and post-colonoscopy immediate surveillance interval recommendation could be given in 70.9% [95% CI 66.5–75.4] of patients. For ≤10mm polyps, agreement with pathology-based surveillance intervals was 92.2% [95% CI 89.6–94.9] (shorter: 5.5% [95% CI 3.3–7.8]; longer: 2.3% [95% CI 0.8–3.7]). NPV for rectosigmoid adenomatous polyps (including SSA) was 83.7% [95% CI 75.9–91.5]. Conclusions The first clinical validation study using the SIMPLE classification in combination with Optivista or iScan IEE showed a high (≥90%) surveillance interval agreement compared to pathology. More than 60% of pathology could be avoided, and most patients could be given immediate surveillance intervals when using IEE in combination with the SIMPLE classification. Funding Agencies NonePentax

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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.

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one-stage surgical resection. European guidelines have suggested that in younger patients, preoperative stenting may be associated with cancer recurrence and have thus discouraged this practice. We hereby evaluated across five hospitals the outcomes of preoperative colonic stenting with regards to cancer recurrence and ostomy rates. Methods: We identified across five hospitals all patients who underwent preoperative colonic stenting for left-side obstructive CRC from 8/2009 to 8/2019. We further stratified patients based on the absence of distant metastasis at diagnosis to evaluate for recurrence rate. Our two comparator groups were patients who underwent upfront surgery either for obstructive CRC or non-obstructive CRC. Outcomes were gathered through extensive chart review. Recurrence was determined radiographically or pathologically. Results: There were 81 patients who had preoperative stenting for obstructive CRC. The rate of stent-related complication was 10%. There was no statistically significant difference in 6-month or 1-year recurrence rate between the stenting and the two upfront surgery groups (3%, 15%, 5% respectively, p-values 0.156 and 1.00). After accounting for lymphovascular and perineural invasion (LVI/PNI), we observed that stenting was associated with a lower 1-year recurrence rate compared to upfront surgery for obstructive CRC in patients with positive LVI/PNI (6% versus 60%, p-value 0.028). In terms of ostomy rates, the stenting group had a 6-month ostomy rate of 23% and 1-year rate of 16%, compared to 41% and 33% respectively (p-values 0.065 and 0.066) in the upfront surgery for obstructive CRC group, and 32% and 16% respectively (p-values 0.425 and 1.00) in the non-obstructive CRC group. Postoperative infection (12%, 13% and 16% respectively for the three groups), leak (9%, 10% and 4% respectively) and total complication (16%, 15% and 16% respectively) rates were similar in the three groups (p-values all > 0.05). Finally, the median post-colectomy hospital stay was 4 days for the stenting group, compared to 6 days for the upfront surgery for obstructed CRC group (p-value 0.0003). Conclusion: We observed, in our multi-center study, that preoperative stenting was not associated with an increased risk of cancer recurrence in patients with obstructive CRC up to one year following surgery. Length of stay was shorter in the stenting group. Interestingly, despite the goal of one-stage surgery with a colonic stent, one-year ostomy rates were similar in both groups. We demonstrated that preoperative stenting does not impact one-year oncologic outcomes in obstructive CRC, however, preoperative stenting may not achieve the goal of remaining ostomy free.