Artificial intelligence-assisted optical diagnosis for the resect-and-discard strategy in clinical practice: the Artificial intelligence BLI Characterization (ABC) study.

Optical diagnosis of colonic polyps is poorly reproducible outside of high volume referral centers. The present study aimed to assess whether real-time artificial intelligence (AI)-assisted optical diagnosis is accurate enough to implement the leave-in-situ strategy for diminutive (≤ 5 mm) rectosigmoid polyps (DRSPs). Consecutive colonoscopy outpatients with ≥ 1 DRSP were included. DRSPs were categorized as adenomas or nonadenomas by the endoscopists, who had differing expertise in optical diagnosis, with the assistance of a real-time AI system (CAD-EYE). The primary end point was ≥ 90 % negative predictive value (NPV) for adenomatous histology in high confidence AI-assisted optical diagnosis of DRSPs (Preservation and Incorporation of Valuable endoscopic Innovations [PIVI-1] threshold), with histopathology as the reference standard. The agreement between optical- and histology-based post-polypectomy surveillance intervals (≥ 90 %; PIVI-2 threshold) was also calculated according to European Society of Gastrointestinal Endoscopy (ESGE) and United States Multi-Society Task Force (USMSTF) guidelines. Overall 596 DRSPs were retrieved for histology in 389 patients; an AI-assisted high confidence optical diagnosis was made in 92.3 %. The NPV of AI-assisted optical diagnosis for DRSPs (PIVI-1) was 91.0 % (95 %CI 87.1 %-93.9 %). The PIVI-2 threshold was met with 97.4 % (95 %CI 95.7 %-98.9 %) and 92.6 % (95 %CI 90.0 %-95.2 %) of patients according to ESGE and USMSTF, respectively. AI-assisted optical diagnosis accuracy was significantly lower for nonexperts (82.3 %, 95 %CI 76.4 %-87.3 %) than for experts (91.9 %, 95 %CI 88.5 %-94.5 %); however, nonexperts quickly approached the performance levels of experts over time. AI-assisted optical diagnosis matches the required PIVI thresholds. This does not however offset the need for endoscopists' high level confidence and expertise. The AI system seems to be useful, especially for nonexperts.

Rondonotti E ，Hassan C ，Tamanini G ，Antonelli G ，Andrisani G ，Leonetti G ，Paggi S ，Amato A ，Scardino G ，Di Paolo D ，Mandelli G ，Lenoci N ，Terreni N ，Andrealli A ，Maselli R ，Spadaccini M ，Galtieri PA ，Correale L ，Repici A ，Di Matteo FM ，Ambrosiani L ，Filippi E ，Sharma P ，Radaelli F ... -  《-》

Guidance for setting easy-to-adopt competence criteria for optical diagnosis of diminutive colorectal polyps: a simulation approach.

One reason the optical diagnosis strategy for diminutive colorectal polyps has not yet been implemented is that the current competence criteria (Preservation and Incorporation of Valuable Endoscopic Innovation [PIVI] initiative) are difficult to use in daily practice. To provide guidance for setting alternative easy-to-adopt competence criteria, we determined the lowest proportion of diminutive polyps that should have a correct optical diagnosis to meet the PIVI. For this simulation study, we used datasets from 2 prospectively collected cohorts of patients who underwent colonoscopy in either a primary colonoscopy or fecal immunochemical test (FIT) screening setting. In the simulation approach, virtual endoscopists or computer-aided diagnosis systems performed optical diagnosis of diminutive polyps with a fixed diagnostic performance level (strategy) on all individuals in the cohort who had ≥1 diminutive polyp. Strategies were defined by systematically varying the proportion of correct optical diagnoses for each polyp subtype (ie, adenomas, hyperplastic polyps, sessile serrated lesions). For each strategy, we determined whether PIVI-1 (≥90% agreement with U.S. or European Society for Gastrointestinal Endoscopy [ESGE] surveillance guidelines) and PIVI-2 (≥90% negative predictive value [NPV] for neoplastic lesions in the rectosigmoid) were met using Monte Carlo sampling with 1000 repetitions, with histology as reference. The level of overall diagnostic accuracy to achieve the PIVI differed significantly depending on the clinical setting and guidelines used. In the colonoscopy screening setting, all diagnostic strategies in which 92% of all diminutive polyps (regardless of histology) were diagnosed correctly led to 90% or more agreement with U.S. surveillance intervals (ie, PIVI-1). For all diagnostic strategies in which ≥89% of all diminutive polyps were correctly diagnosed, at least 90% NPV was achieved (ie, PIVI-2). For the FIT screening setting, values were respectively ≥77% and ≥94%. When using ESGE guidelines, PIVI-1 was in both settings already met when 40% of all diminutive polyps were diagnosed correctly. In contrast to the fixed PIVI criteria, our simulation study shows that different thresholds for the proportion of correctly diagnosed diminutive polyps lead to different clinical consequences depending on guidelines and clinical setting. However, this target proportion of diminutive colorectal polyps correctly diagnosed with optical diagnosis represents easier-to-adopt competence criteria.

Houwen BBSL ，Greuter MJE ，Vleugels JLA ，Hazewinkel Y ，Bisschops R ，Dekker E ，Coupé VMH ... -  《-》

ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps.

In vivo real-time assessment of the histology of diminutive (≤5 mm) colorectal polyps detected at colonoscopy can be achieved by means of an "optical biopsy" by using currently available endoscopic technologies. This systematic review and meta-analysis was performed by the American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee to specifically assess whether acceptable performance thresholds outlined by an ASGE Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document for clinical adoption of these technologies have been met. We conducted direct meta-analyses calculating the pooled negative predictive value (NPV) for narrow-band imaging (NBI), i-SCAN, and Fujinon Intelligent Color Enhancement (FICE)-assisted optical biopsy for predicting adenomatous polyp histology of small/diminutive colorectal polyps. We also calculated the pooled percentage agreement with histopathology when assigning postpolypectomy surveillance intervals based on combining real-time optical biopsy of colorectal polyps 5 mm or smaller with histopathologic assessment of polyps larger than 5 mm. Random-effects meta-analysis models were used. Statistical heterogeneity was evaluated by means of I(2) statistics. Our meta-analyses indicate that optical biopsy with NBI, exceeds the NPV threshold for adenomatous polyp histology, supporting a "diagnose-and-leave" strategy for diminutive predicted nonneoplastic polyps in the rectosigmoid colon. The pooled NPV of NBI for adenomatous polyp histology by using the random-effects model was 91% (95% confidence interval [CI], 88-94). This finding was associated with a high degree of heterogeneity (I(2) = 89%). Subgroup analysis indicated that the pooled NPV was greater than 90% for academic medical centers (91.8%; 95% CI, 89-94), for experts (93%; 95% CI, 91-96), and when the optical biopsy assessment was made with high confidence (93%; 95% CI, 90-96). Our meta-analyses also indicate that the agreement in assignment of postpolypectomy surveillance intervals based on optical biopsy with NBI of diminutive colorectal polyps is 90% or greater in academic settings (91%; 95% CI, 86-95), with experienced endoscopists (92%; 95% CI, 88-96) and when optical biopsy assessments are made with high confidence (91%; 95% CI, 88-95). Our systematic review and meta-analysis confirms that the thresholds established by the ASGE PIVI for real-time endoscopic assessment of the histology of diminutive polyps have been met, at least with NBI optical biopsy, with endoscopists who are expert in using this advanced imaging technology and when assessments are made with high confidence.

ASGE Technology Committee ，Abu Dayyeh BK ，Thosani N ，Konda V ，Wallace MB ，Rex DK ，Chauhan SS ，Hwang JH ，Komanduri S ，Manfredi M ，Maple JT ，Murad FM ，Siddiqui UD ，Banerjee S ... -  《-》

Artificial Intelligence Allows Leaving-In-Situ Colorectal Polyps.

Artificial Intelligence (AI) could support cost-saving strategies for colonoscopy because of its accuracy in the optical diagnosis of colorectal polyps. However, AI must meet predefined criteria to be implemented in clinical settings. An approved computer-aided diagnosis (CADx) module for differentiating between adenoma and nonadenoma in unmagnified white-light colonoscopy was used in a consecutive series of colonoscopies. For each polyp, CADx output and subsequent endoscopist diagnosis with advanced imaging were matched against the histology gold standard. The primary outcome was the negative predictive value (NPV) of CADx for adenomatous histology for ≤5-mm rectosigmoid lesions. We also calculated the NPV for AI-assisted endoscopist predictions, and agreement between CADx and histology-based postpolypectomy surveillance intervals according to European and American guidelines. Overall, 544 polyps were removed in 162 patients, of which 295 (54.2%) were ≤5-mm rectosigmoid histologically verified lesions. CADx diagnosis was feasible in 291 of 295 (98.6%), and the NPV for ≤5-mm rectosigmoid lesions was 97.6% (95% CI, 94.1%-99.1%). There were 242 of 295 (82%) lesions that were amenable for a leave-in-situ strategy. Based on CADx output, 212 of 544 (39%) would be amenable to a resect-and-discard strategy, resulting in a 95.6% (95% CI, 90.8%-98.0%) and 95.9% (95% CI, 89.8%-98.4%) agreement between CADx- and histology-based surveillance intervals according to European and American guidelines, respectively. A similar NPV (97.6%; 95% CI, 94.8%-99.1%) for ≤5-mm rectosigmoids was achieved by AI-assisted endoscopists assessing polyps with electronic chromoendoscopy, with a CADx-concordant diagnosis in 97.2% of cases. In this study, CADx without advanced imaging exceeded the benchmarks required for optical diagnosis of colorectal polyps. CADx could help implement cost-saving strategies in colonoscopy by reducing the burden of polypectomy and/or pathology. gov registration number: NCT04884581.

Hassan C ，Balsamo G ，Lorenzetti R ，Zullo A ，Antonelli G ... -  《-》

Clinical Validation of BASIC Classification for the Resect and Discard Strategy for Diminutive Colorectal Polyps.

Blue-light imaging (BLI) is a chromoendoscopy technique that uses direct (not filtered) emission of blue light with short wavelength (410 nm) to increase visibility of microvascular pattern and superficial mucosa. A BLI-based classification system for colorectal polyps (also called BLI Adenomas Serrated International Classification, BASIC) has been created and was validated using still images or short videos. We aimed to validate BASIC in a clinical practice setting, using thresholds recommended by the American Society for Gastrointestinal Endoscopy for the resect and discard strategy as the reference standard. We studied 333 patients (mean age, 62.7±8.1 y; 176 men) who underwent screening colonoscopy from January through July 2019. Six endoscopists trained in BASIC participated in the study. All detected diminutive polyps were characterized by real-time BLI and categorized as adenoma or non-adenoma according to BASIC. All polyps were removed and evaluated by histopathology. The BLI-directed surveillance intervals (based on high-confidence characterization of polyps 5 mm or smaller and pathology feature for others) were compared with histology-directed surveillance intervals, according to United States Multi-society Task Force and European Society of Gastrointestinal Endoscopy recommendations. We calculated negative-predictive values of optical real-time analysis of diminutive rectosigmoid adenomas. When we applied BASIC, 748 polyps smaller than 5 mm were categorized with 89% accuracy (95% CI, 85.9%-90.6%). BLI-directed surveillance was correct for 90% of patients according to the United States Multi-society task force criteria (95% CI, 86%-93%) and for 96% of patients according to European Society of Gastrointestinal Endoscopy criteria (95% CI, 93%-97%). The negative-predictive value for 302 polyps smaller than 5 mm, located in the rectosigmoid colon and evaluated with high confidence, based on histologic features of adenomatous polyps, was 91% (95% CI, 85%-95%). Our analysis of data from 333 patients undergoing screen colonoscopies supports the validity of BASIC discriminating diminutive colorectal polyps with histologic features of adenomas from non-adenomas. This allows for the implementation of the resect and discard strategy based on BLI in clinical practice. ClinicalTrials.gov no: NCT03746171.

Rondonotti E ，Hassan C ，Andrealli A ，Paggi S ，Amato A ，Scaramella L ，Repici A ，Radaelli F ... -  《-》