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Item The colonoscopist's guide to the vocabulary of colorectal neoplasia: histology, morphology, and management(Elsevier, 2017) Rex, Douglas K.; Hassan, Cesare; Bourke, Michael J.; Department of Medicine, IU School of MedicinePrevention of colorectal cancer by colonoscopy requires effective and safe insertion technique, high level detection of precancerous lesions, and skillful use of curative endoscopic resection techniques. Lesion detection, characterization, use of appropriate resection methods, prediction of cancer at colonoscopy, and management of malignant polyps, all depend on an accurate and complete understanding of an extensive vocabulary describing the histology and morphology of neoplastic colorectal lesions. Incomplete understanding of vocabulary terms can lead to management errors. We provide a colonoscopist’s perspective on the vocabulary of colorectal neoplasia, and discuss the interaction of specific terms with management decisions.Item Combination of Mucosa-Exposure Device and Computer-Aided Detection for Adenoma Detection During Colonoscopy: A Randomized Trial(Elsevier, 2023-07) Spadaccini, Marco; Hassan, Cesare; Rondonotti, Emanuele; Antonelli, Giulio; Andrisani, Gianluca; Lollo, Gianluca; Auriemma, Francesco; Iacopini, Federico; Facciorusso, Antonio; Maselli, Roberta; Fugazza, Alessandro; Bambina Bergna, Irene Maria; Cereatti, Fabrizio; Mangiavillano, Benedetto; Radaelli, Franco; Di Matteo, Francesco; Gross, Seth A.; Sharma, Prateek; Mori, Yuichi; Bretthauer, Michael; Rex, Douglas K.; Repici, Alessandro; Medicine, School of MedicineBackground & Aims Both computer-aided detection (CADe)-assisted and Endocuff-assisted colonoscopy have been found to increase adenoma detection. We investigated the performance of the combination of the 2 tools compared with CADe-assisted colonoscopy alone to detect colorectal neoplasias during colonoscopy in a multicenter randomized trial. Methods Men and women undergoing colonoscopy for colorectal cancer screening, polyp surveillance, or clincial indications at 6 centers in Italy and Switzerland were enrolled. Patients were assigned (1:1) to colonoscopy with the combinations of CADe (GI-Genius; Medtronic) and a mucosal exposure device (Endocuff Vision [ECV]; Olympus) or to CADe-assisted colonoscopy alone (control group). All detected lesions were removed and sent to histopathology for diagnosis. The primary outcome was adenoma detection rate (percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, advanced adenomas and serrated lesions detection rate, the rate of unnecessary polypectomies (polyp resection without histologically proven adenomas), and withdrawal time. Results From July 1, 2021 to May 31, 2022, there were 1316 subjects randomized and eligible for analysis; 660 to the ECV group, 656 to the control group). The adenoma detection rate was significantly higher in the ECV group (49.6%) than in the control group (44.0%) (relative risk, 1.12; 95% CI, 1.00–1.26; P = .04). Adenomas detected per colonoscopy were significantly higher in the ECV group (mean ± SD, 0.94 ± 0.54) than in the control group (0.74 ± 0.21) (incidence rate ratio, 1.26; 95% CI, 1.04–1.54; P = .02). The 2 groups did not differ in term of detection of advanced adenomas and serrated lesions. There was no significant difference between groups in mean ± SD withdrawal time (9.01 ± 2.48 seconds for the ECV group vs 8.96 ± 2.24 seconds for controls; P = .69) or proportion of subjects undergoing unnecessary polypectomies (relative risk, 0.89; 95% CI, 0.69–1.14; P = .38). Conclusions The combination of CADe and ECV during colonoscopy increases adenoma detection rate and adenomas detected per colonoscopy without increasing withdrawal time compared with CADe alone.Item Comparative Performance of Artificial Intelligence Optical Diagnosis Systems for Leaving in Situ Colorectal Polyps(Elsevier, 2023-03) Hassan, Cesare; Sharma, Prateek; Mori, Yuichi; Bretthauer, Michael; Rex, Douglas K.; COMBO Study Group; Repici, Alessandro; Medicine, School of MedicineItem Diagnostic Yield and Miss Rate of EndoRings in an Organized Colorectal Cancer Screening Program: the SMART (Study Methodology for ADR-Related Technology) Trial(Elsevier, 2018) Hassan, Cesare; Senore, Carlo; Manes, Gianpiero; Fuccio, Lorenzo; Iacopini, Federico; Ricciardiello, Luigi; Anderloni, Andrea; Frazzoni, Leonardo; Ballanti, Riccardo; de Nucci, Germana; Colussi, Dora; Radaelli, Davide; Lorenzetti, Roberto; Devani, Massimo; Arena, Ilaria; Grossi, Cristina; Andrei, Fabio; Balestrazzi, Eleonora; Sharma, Prateek; Rex, Douglas K.; Repici, Alessandro; Medicine, School of MedicineBackground and aims The add-on EndoRings has been claimed to improve adenoma detection at colonoscopy, but available data are inconsistent. When testing a new technology, parallel and crossover methodologies measure different outcomes, leaving uncertainty on their correspondence. Aims of this study were to compare the diagnostic yield and miss rate of the EndoRings for colorectal neoplasia. Methods Consecutive subjects undergoing colonoscopy after a positive fecal immunochemical test (FIT) within organized screening program in 7 Italian centers, were randomized between a parallel (EndoRings or Standard) or a crossover (EndoRings/Standard or Standard/EndoRings) methodology. Outcomes measures were the detection rates of (advanced) adenomas (A-)ADR in the parallel arms and miss rate of adenomas in the crossover arms. Results Of 958 eligible subjects, 927 (317 EndoRings; 317 Standard; 142 EndoRings/Standard; 151 Standard/Endorings) were included in the final analysis. In the parallel arms (mean ADR: 51.3%; mean AADR: 25.4%), no difference between Standard and EndoRings was found for both ADR (RR, 1.10; 95% CI, 0.95-1.28) and A-ADR (RR, 1.16; 95% CI, 0.88-1.51), as well as for the mean number of adenomas and advanced adenomas per patient (EndoRings: 1.9±1.3 and 1.0±1.2; Standard 2.1±1.5 and 1.0±1.2; p=NS for both comparisons). In the crossover arms, no difference in miss rate for adenomas between EndoRings and Standard was found at per-polyp (RR, 1.43; 95% CI, 0.97-2.10), as well as at per-patient analysis (24% vs 26%; p=0.76). Conclusions No statistically significant difference in diagnostic yield and miss rate between EndoRings and Standard colonoscopy was detected in FIT+ patients. A clinically relevant correspondence between miss and detection rates was shown, supporting a cause-effect relationship.Item Dye-based chromoendoscopy for the detection of colorectal neoplasia: meta-analysis of randomized controlled trials.(Elsevier, 2022) Antonelli, Giulio; Correale, Loredana; Spadaccini, Marco; Maselli, Roberta; Bhandari, Pradeep; Bisschops, Raf; Cereatti, Fabrizio; Dekker, Evelien; East, James E.; Iacopini, Federico; Jover, Rodrigo; Kiesslich, Ralph; Pellise, Maria; Sharma, Prateek; Rex, Douglas K.; Repici, Alessandro; Hassan, Cesare; Medicine, School of MedicineBackground and Aims Dye-Based chromoendoscopy (DBC) could be effective in increasing adenoma detection rate (ADR) in patients undergoing colonoscopy, but the technique is time-consuming and its uptake is limited. We aimed to assess the effect of DBC on ADR based on available randomized controlled trials (RCTs). Methods Four databases were searched up to April 2022, for RCTs comparing DBC with conventional colonoscopy (CC) in terms of ADR, advanced ADR, and sessile serrated adenoma (SSA) detection rates as well as the mean number of adenomas per patient (MAP) and non-neoplastic lesions. Relative risk (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes were calculated using random-effect models. I2 test was used for quantifying heterogeneity. Risk of bias was evaluated with Cochrane tool. Results Overall, 10 RCTs (5,334 patients) were included. Indication for colonoscopy was screening or surveillance (3 studies), and mixed (7 studies). Pooled ADR was higher in the DBC group vs. CC group, (48.1%[41.4-54.8%] vs 39.3%[33.5-46.4%]; RR=1.20[1.11- 1.29]), with low heterogeneity (I2=29%). This effect was consistent for advanced ADR (RR=1.21[1.03-1.42] I2=0.0%), and for SSA (6.1% vs 3.5%; RR, 1.68; [1.15-2.47]; I2=9.8%), as well as for MAP (MD 0.24 [0.17–0.31]) overall and in the right colon (MD, 0.28 [0.14-0.43]. High-definition white-light colonoscopy (HDWL) was more effective than standard white-light colonoscopy (SDWL) for detection of adenomas (51.6% 95% CI:47.1-56.1% vs. 34.2%; 95% CI:28.5-40.4%) and DBC (59.1%; 95% CI:54.7-63.3%) was more effective than HDWL (RR=1.14; 95% CI:1.06-1.23, I2= 0.0%]. Conclusions Meta-analysis of RCTs showed that DBC increases key quality parameters in colonoscopy, supporting its use in every-day clinical practice.Item Efficacy and Tolerability of High- vs Low-Volume Split-Dose Bowel Cleansing Regimens for Colonoscopy: A Systematic Review and Meta-analysis(Elsevier, 2019) Spadaccini, Marco; Frazzoni, Leonardo; Vanella, Giuseppe; East, James; Radaelli, Franco; Spada, Cristiano; Fuccio, Lorenzo; Benamouzig, Robert; Bisschops, Raf; Bretthauer, Michael; Dekker, Evelien; Dinis-Ribeiro, Mario; Ferlitsch, Monika; Gralnek, Ian; Jover, Rodrigo; Kaminski, Michael F.; Pellisé, Maria; Triantafyllou, Konstantinos; Van Hooft, Jeanin E.; Dumonceau, Jean-Marc; Marmo, Clelia; Alfieri, Sergio; Chandrasekar, Viveksandeep Thoguluva; Sharma, Prateek; Rex, Doug K.; Repici, Alessandro; Hassan, Cesare; Medicine, School of MedicineBackground & Aims Efficacy of bowel preparation is an important determinant of outcomes of colonoscopy. It is not clear whether approved low-volume polyethylene glycol (PEG) and non-PEG regimens are as effective as high-volume PEG regimens when taken in a split dose. Methods In a systematic review of multiple electronic databases through January 31, 2019 with a registered protocol (PROSPERO: CRD42019128067), we identified randomized controlled trials that compared low- vs high-volume bowel cleansing regimens, administered in a split dose, for colonoscopy. The primary efficacy outcome was rate of adequate bowel cleansing, and the secondary efficacy outcome was adenoma detection rate. Primary tolerability outcomes were compliance, tolerability, and willingness to repeat. We calculated relative risk (RR) and 95% CI values and assessed heterogeneity among studies by using the I2 statistic. The overall quality of evidence was assessed using the GRADE framework. Results In an analysis of data from 17 randomized controlled trials, comprising 7528 patients, we found no significant differences in adequacy of bowel cleansing between the low- vs high-volume split-dose regimens (86.1% vs 87.4%; RR, 1.00; 95% CI, 0.98–1.02) and there was minimal heterogeneity (I2 = 17%). There was no significant difference in adenoma detection rate (RR, 0.96; 95% CI, 0.87–1.08) among 4 randomized controlled trials. Compared with high-volume, split-dose regimens, low-volume split-dose regimens had higher odds for compliance or completion (RR, 1.06; 95% CI, 1.02–1.10), tolerability (RR, 1.39; 95% CI, 1.12–1.74), and willingness to repeat bowel preparation (RR, 1.41; 95% CI, 1.20–1.66). The overall quality of evidence was moderate. Conclusions Based on a systematic review of 17 randomized controlled trials, low-volume, split-dose regimens appear to be as effective as high-volume, split-dose regimens in bowel cleansing and are better tolerated, with superior compliance.Item High-definition colonoscopy versus Endocuff versus EndoRings versus Full-Spectrum Endoscopy for adenoma detection at colonoscopy: a multicenter randomized trial(Elsevier, 2018) Rex, Douglas K.; Repici, Alessandro; Gross, Seth A.; Hassan, Cesare; Ponugoti, Prasanna L.; Garcia, Jonathan R.; Broadley, Heather M.; Thygesen, Jack C.; Sullivan, Andrew W.; Tippins, William W.; Main, Samuel A.; Eckert, George J.; Vemulapalli, Krishna C.; Medicine, School of MedicineBackground Devices used to improve polyp detection during colonoscopy have seldom been compared with each other. Methods We performed a 3-center prospective randomized trial comparing high-definition (HD) forward-viewing colonoscopy alone to HD with Endocuff to HD with EndoRings to the Full Spectrum Endoscopy (FUSE) system. Patients were age ≥50 years and had routine indications and intact colons. The study colonoscopists were all proven high-level detectors. The primary endpoint was adenomas per colonoscopy (APC) Results Among 1,188 patients who completed the study, APC with Endocuff (APC Mean ± SD 1.82 ± 2.58), EndoRings (1.55 ± 2.42), and standard HD colonoscopy (1.53 ± 2.33) were all higher than FUSE (1.30 ± 1.96,) (p<0.001 for APC). Endocuff was higher than standard HD colonoscopy for APC (p=0.014) . Mean cecal insertion times with FUSE (468 ± 311 seconds) and EndoRings (403 ± 263 seconds) were both longer than with Endocuff (354 ± 216 seconds) (p=0.006 and 0.018, respectively). Conclusions For high-level detectors at colonoscopy, forward-viewing HD instruments dominate the FUSE system, indicating that for these examiners image resolution trumps angle of view. Further, Endocuff is a dominant strategy over EndoRings and no mucosal exposure device on a forward-viewing HD colonoscope.Item New and Recurrent Colorectal Cancers After Resection: a Systematic Review and Meta-analysis of Endoscopic Surveillance Studies(Elsevier, 2019) Fuccio, Lorenzo; Rex, Douglas K.; Ponchon, Thierry; Frazzoni, Leonardo; Dinis-Ribeiro, Mário; Bhandari, Pradeep; Dekker, Evelien; Pellisè, Maria; Correale, Loredana; van Hooft, Jeanin; Jover, Rodrigo; Libanio, Diogo; Radaelli, Franco; Alfieri, Sergio; Bazzoli, Franco; Senore, Carlo; Regula, Jaroslaw; Seufferlein, Thomas; Rösch, Thomas; Sharma, Prateek; Repici, Alessandro; Hassan, Cesare; Medicine, School of MedicineBackground & Aims Outcomes of endoscopic surveillance following surgery for colorectal cancer (CRC) vary with the incidence and timing of CRC detection, at anastomoses or non- anastomoses in the colorectum. We performed a systematic review and meta-analysis to evaluate the incidence of CRCs identified during surveillance colonoscopies of patients who have already undergone surgery for this cancer. Methods We searched PubMed, EMBASE, SCOPUS, and the Cochrane Central Register of Clinical Trials through January 1, 2018 to identify studies investigating rates of CRCs at anastomoses or other locations in the colorectum after curative surgery for primary CRC. We collected data from published randomized controlled, prospective, and retrospective cohort studies. Data were analyzed by multivariate meta-analytic models. Results From 2373 citations, we selected 27 studies with data on 15,803 index CRCs for analysis (89% of patients with stage 1–3 CRC). Overall, 296 CRCs at non-anastomotic locations were reported over time periods of more than 16 years (cumulative incidence, 2.2% of CRCs; 95% CI, 1.8%–2.9%). The risk of CRC at a non-anastomotic location was significantly reduced more than 36 months after resection compared with before this timepoint (odds ratio for non-anastomotic CRCs at 36–48 months vs 6–12 months after surgery, 0.61; 95% CI, 0.37–0.98; P=.031); 53.7% of all non-anastomotic CRCs were detected within 36 months of surgery. One hundred fifty-eight CRCs were detected at anastomoses (cumulative incidence of 2.7%; 95% CI, 1.9%–3.9%). The risk of CRCs at anastomoses was significantly lower 24 months after resection than before (odds ratio for CRCs at anastomoses at 25–36 months after surgery vs 6–12 months, 0.56; 95% CI, 0.32–0.98; P=.036); 90.8% of all CRCs at anastomoses were detected within 36 months of surgery. Conclusions After surgery for CRC, the highest risk of CRCs at anastomoses and at other locations in the colorectum is highest during 36 months after surgery—risk decreases thereafter. Patients who have undergone CRC resection should be evaluated by colonoscopy more closely during this time period. Longer intervals may be considered thereafter.Item Performance of artificial intelligence for colonoscopy regarding adenoma and polyp detection: a meta-analysis(Elsevier, 2020) Hassan, Cesare; Spadaccini, Marco; Iannone, Andrea; Maselli, Roberta; Jovani, Manol; Chandrasekar, Viveksandeep Thoguluva; Antonelli, Giulio; Yu, Honggang; Areia, Miguel; Dinis-Ribeiro, Mario; Bhandari, Pradeep; Sharma, Prateek; Rex, Douglas K.; Rösch, Thomas; Wallace, Michael; Repici, Alessandro; Medicine, School of MedicineBACKGROUND AND AIMS One fourth of colorectal neoplasia is missed at screening colonoscopy, representing the main cause of interval colorectal cancer (CRC). Deep learning systems with real-time computer-aided polyp detection (CADe) showed high accuracy in artificial settings, and preliminary randomized clinical trials (RCT) reported favourable outcomes in clinical setting. Aim of this meta-analysis was to summarise available RCTs on the performance of CADe systems in colorectal neoplasia detection. METHODS We searched MEDLINE, EMBASE and Cochrane Central databases until March 2020 for RCTs reporting diagnostic accuracy of CADe systems in detection of colorectal neoplasia. Primary outcome was pooled adenoma detection rate (ADR), Secondary outcomes were adenoma per colonoscopy (APC) according to size, morphology and location, advanced APC (AAPC), as well as polyp detection rate (PDR), Polyp-per-colonoscopy (PPC), and sessile serrated lesion per colonoscopy (SPC). We calculated risk ratios (RR), performed subgroup, and sensitivity analysis, assessed heterogeneity, and publication bias. RESULTS Overall, 5 randomized controlled trials (4354 patients), were included in the final analysis. Pooled ADR was significantly higher in the CADe groups than in the control group (791/2163, 36.6% vs 558/2191, 25.2%; RR, 1.44; 95% CI, 1.27-1.62; p<0.01; I 2:42%). APC was also higher in the CADe group compared with control (1249/2163, 0.58 vs 779/2191, 0.36; RR, 1.70; 95% CI, 1.53-1.89; p<0.01;I 2:33%). APC was higher for <5 mm (RR, 1.69; 95% CI, 1.48-1.84), 6-9 mm (RR, 1.44; 95% CI, 1.19-1.75), and >10 mm adenomas (RR, 1.46; 95% CI, 1.04-2.06), as well as for proximal (RR, 1.59; 95% CI, 1.34-1.88) and distal (RR, 1.68; 95% CI, 1.50-1.88), and for flat (RR: 1.78 95% CI 1.47-2.15) and polypoid morphology (RR, 1.54; 95% CI, 1.40-1.68). Regarding histology, CADe resulted in a higher SPC (RR, 1.52; 95% CI,1.14-2.02), whereas a nonsignificant trend for AADR was found (RR, 1.35; 95% CI, 0.74 – 2.47; p = 0.33; I 2:69%). Level of evidence for RCTs was graded moderate. CONCLUSIONS According to available evidence, the incorporation of Artificial Intelligence as aid for detection of colorectal neoplasia results in a significant increase of the detection of colorectal neoplasia, and such effect is independent from main adenoma characteristics.Item Prophylactic Clipping After Colorectal Endoscopic Resection Prevents Bleeding of Large, Proximal Polyps: Meta-Analysis of Randomized Trials(Elsevier, 2020) Spadaccini, Marco; Albéniz, Eduardo; Pohl, Heiko; Maselli, Roberta; Chandrasekar, Viveksandeep Thoguluva; Correale, Loredana; Anderloni, Andrea; Carrara, Silvia; Fugazza, Alessandro; Badalamenti, Matteo; Iwatate, Mineo; Antonelli, Giulio; Enguita-Germán, Mónica; Álvarez, Marco Antonio; Sharma, Prateek; Rex, Douglas K.; Hassan, Cesare; Repici, Alessandro; Medicine, School of MedicineBackground & Aims The benefits of prophylactic clipping to prevent bleeding after polypectomy are unclear. We conducted an updated meta-analysis of randomized trials to assess the efficacy of clipping in preventing bleeding after polypectomy, overall and according to polyp size and location. Methods We searched the Medline/PubMed, EMBASE, and Scopus databases randomized trials that compared effects of clipping vs not clipping to prevent bleeding after polypectomy. We performed a random-effects meta-analysis to generate pooled relative risks (RRs) with 95% CIs. Multilevel random-effects meta-regression analysis was used to combine data on bleeding after polypectomy and estimate associations between rates of bleeding and polyp characteristics. Results We analyzed data from 9 trials, comprising 7197 colorectal lesions (22.5% 20 mm or larger, 49.2% with proximal location). Clipping, compared with no clipping, did not significantly reduce the overall risk of post-polypectomy bleeding (2.2% with clipping vs 3.3% with no clipping; RR, 0.69; 95% CI, 0.45–1.08; P=.072). Clipping significantly reduced risk of bleeding after removal of polyps that were 20 mm or larger (4.3% had bleeding after clipping vs 7.6% had bleeding with no clipping; RR, 0.51; 95% CI, 0.33–0.78; P=.020) or that were in a proximal location (3.0% had bleeding after clipping vs 6.2% had bleeding with no clipping; RR, 0.53; 95% CI, 0.35–0.81; P<.001). In multilevel meta-regression analysis that adjusted for polyp size and location, prophylactic clipping was significantly associated with reduced risk of bleeding after removal of large proximal polyps (RR, 0.37; 95% CI, 0.22–0.61; P=.021) but not small proximal lesions (RR, 0.88; 95% CI, 0.48–1.62; P=0.581). Conclusions In a meta-analysis of randomized trials, we found that routine use of prophylactic clipping does not reduce risk of post-polypectomy bleeding, overall. However, clipping appeared to reduce bleeding after removal of large (more than 20 mm), proximal lesions.