Browsing by Author "Sharma, Prateek"
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Item 'Artificial intelligence in Barrett's Esophagus'(Sage, 2021-10-12) Hamade, Nour; Sharma, Prateek; Medicine, School of MedicineDespite advances in endoscopic imaging modalities, there are still significant miss rates of dysplasia and cancer in Barrett's esophagus. Artificial intelligence (AI) is a promising tool that may potentially be a useful adjunct to the endoscopist in detecting subtle dysplasia and cancer. Studies have shown AI systems have a sensitivity of more than 90% and specificity of more than 80% in detecting Barrett's related dysplasia and cancer. Beyond visual detection and diagnosis, AI may also prove to be useful in quality control, streamlining clinical work, documentation, and lessening the administrative load on physicians. Research in this area is advancing at a rapid rate, and as the field expands, regulations and guidelines will need to be put into place to better regulate the growth and use of AI. This review provides an overview of the present and future role of AI in Barrett's esophagus.Item Baseline Features and Reasons for Nonparticipation in the Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM) Study, a Colorectal Cancer Screening Trial(American Medical Association, 2023-07-03) Robertson, Douglas J.; Dominitz, Jason A.; Beed, Alexander; Boardman, Kathy D.; Del Curto, Barbara J.; Guarino, Peter D.; Imperiale, Thomas F.; LaCasse, Andrew; Larson, Meaghan F.; Gupta, Samir; Lieberman, David; Planeta, Beata; Shaukat, Aasma; Sultan, Shanaz; Menees, Stacy B.; Saini, Sameer D.; Schoenfeld, Philip; Goebel, Stephan; von Rosenvinge, Erik C.; Baffy, Gyorgy; Halasz, Ildiko; Pedrosa, Marcos C.; Kahng, Lyn Sue; Cassim, Riaz; Greer, Katarina B.; Kinnard, Margaret F.; Bhatt, Divya B.; Dunbar, Kerry B.; Harford, William V.; Mengshol, John A.; Olson, Jed E.; Patel, Swati G.; Antaki, Fadi; Fisher, Deborah A.; Sullivan, Brian A.; Lenza, Christopher; Prajapati, Devang N.; Wong, Helen; Beyth, Rebecca; Lieb, John G.; Manlolo, Joseph; Ona, Fernando V.; Cole, Rhonda A.; Khalaf, Natalia; Kahi, Charles J.; Kohli, Divyanshoo Rai; Rai, Tarun; Sharma, Prateek; Anastasiou, Jiannis; Hagedorn, Curt; Fernando, Ronald S.; Jackson, Christian S.; Jamal, M. Mazen; Lee, Robert H.; Merchant, Farrukh; May, Folasade P.; Pisegna, Joseph R.; Omer, Endashaw; Parajuli, Dipendra; Said, Adnan; Nguyen, Toan D.; Tombazzi, Claudio Ruben; Feldman, Paul A.; Jacob, Leslie; Koppelman, Rachel N.; Lehenbauer, Kyle P.; Desai, Deepak S.; Madhoun, Mohammad F.; Tierney, William M.; Ho, Minh Q.; Hockman, Heather J.; Lopez, Christopher; Carter Paulson, Emily; Tobi, Martin; Pinillos, Hugo L.; Young, Michele; Ho, Nancy C.; Mascarenhas, Ranjan; Promrat, Kirrichai; Mutha, Pritesh R.; Pandak, William M.; Shah, Tilak; Schubert, Mitchell; Pancotto, Frank S.; Gawron, Andrew J.; Underwood, Amelia E.; Ho, Samuel B.; Magno-Pagatzaurtundua, Priscilla; Toro, Doris H.; Beymer, Charles H.; Kaz, Andrew M.; Elwing, Jill; Gill, Jeffrey A.; Goldsmith, Susan F.; Yao, Michael D.; Protiva, Petr; Pohl, Heiko; Kyriakides, Tassos; CONFIRM Study Group; Medicine, School of MedicineImportance: The Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM) randomized clinical trial sought to recruit 50 000 adults into a study comparing colorectal cancer (CRC) mortality outcomes after randomization to either an annual fecal immunochemical test (FIT) or colonoscopy. Objective: To (1) describe study participant characteristics and (2) examine who declined participation because of a preference for colonoscopy or stool testing (ie, fecal occult blood test [FOBT]/FIT) and assess that preference's association with geographic and temporal factors. Design, setting, and participants: This cross-sectional study within CONFIRM, which completed enrollment through 46 Department of Veterans Affairs medical centers between May 22, 2012, and December 1, 2017, with follow-up planned through 2028, comprised veterans aged 50 to 75 years with an average CRC risk and due for screening. Data were analyzed between March 7 and December 5, 2022. Exposure: Case report forms were used to capture enrolled participant data and reasons for declining participation among otherwise eligible individuals. Main outcomes and measures: Descriptive statistics were used to characterize the cohort overall and by intervention. Among individuals declining participation, logistic regression was used to compare preference for FOBT/FIT or colonoscopy by recruitment region and year. Results: A total of 50 126 participants were recruited (mean [SD] age, 59.1 [6.9] years; 46 618 [93.0%] male and 3508 [7.0%] female). The cohort was racially and ethnically diverse, with 748 (1.5%) identifying as Asian, 12 021 (24.0%) as Black, 415 (0.8%) as Native American or Alaska Native, 34 629 (69.1%) as White, and 1877 (3.7%) as other race, including multiracial; and 5734 (11.4%) as having Hispanic ethnicity. Of the 11 109 eligible individuals who declined participation (18.0%), 4824 (43.4%) declined due to a stated preference for a specific screening test, with FOBT/FIT being the most preferred method (2820 [58.5%]) vs colonoscopy (1958 [40.6%]; P < .001) or other screening tests (46 [1.0%] P < .001). Preference for FOBT/FIT was strongest in the West (963 of 1472 [65.4%]) and modest elsewhere, ranging from 199 of 371 (53.6%) in the Northeast to 884 of 1543 (57.3%) in the Midwest (P = .001). Adjusting for region, the preference for FOBT/FIT increased by 19% per recruitment year (odds ratio, 1.19; 95% CI, 1.14-1.25). Conclusions and relevance: In this cross-sectional analysis of veterans choosing nonenrollment in the CONFIRM study, those who declined participation more often preferred FOBT or FIT over colonoscopy. This preference increased over time and was strongest in the western US and may provide insight into trends in CRC screening preferences.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 Computer-aided detection for colorectal neoplasia in randomized and non-randomized studies(Thieme, 2024-04-23) Mori, Yuichi; Patel, Harsh K.; Repici, Alessandro; Rex, Douglas K.; Sharma, Prateek; Hassan, Cesare; Medicine, School of MedicineItem Cost-effectiveness of artificial intelligence for screening colonoscopy: a modelling study(Elsevier, 2022) Areia, Miguel; Mori, Yuichi; Correale, Loredana; Repici, Alessandro; Bretthauer, Michael; Sharma, Prateek; Taveira, Filipe; Spadaccini, Marco; Antonelli, Giulio; Ebigbo, Alanna; Kudo, Shin-ei; Arribas, Julia; Barua, Ishita; Kaminski, Michal F.; Messmann, Helmut; Rex, Douglas K.; Dinis-Ribeiro, Mário; Hassan, Cesare; Medicine, School of MedicineBackground: Artificial intelligence (AI) tools increase detection of precancerous polyps during colonoscopy and might contribute to long-term colorectal cancer prevention. The aim of the study was to investigate the incremental effect of the implementation of AI detection tools in screening colonoscopy on colorectal cancer incidence and mortality, and the cost-effectiveness of such tools. Methods: We conducted Markov model microsimulation of using colonoscopy with and without AI for colorectal cancer screening for individuals at average risk (no personal or family history of colorectal cancer, adenomas, inflammatory bowel disease, or hereditary colorectal cancer syndrome). We ran the microsimulation in a hypothetical cohort of 100 000 individuals in the USA aged 50-100 years. The primary analysis investigated screening colonoscopy with versus without AI every 10 years starting at age 50 years and finishing at age 80 years, with follow-up until age 100 years, assuming 60% screening population uptake. In secondary analyses, we modelled once-in-life screening colonoscopy at age 65 years in adults aged 50-79 years at average risk for colorectal cancer. Post-polypectomy surveillance followed the simplified current guideline. Costs of AI tools and cost for downstream treatment of screening detected disease were estimated with 3% annual discount rates. The main outcome measures included the incremental effect of AI-assisted colonoscopy versus standard (no-AI) colonoscopy on colorectal cancer incidence and mortality, and cost-effectiveness of screening projected for the average risk screening US population. Findings: In the primary analyses, compared with no screening, the relative reduction of colorectal cancer incidence with screening colonoscopy without AI tools was 44·2% and with screening colonoscopy with AI tools was 48·9% (4·8% incremental gain). Compared with no screening, the relative reduction in colorectal cancer mortality with screening colonoscopy with no AI was 48·7% and with screening colonoscopy with AI was 52·3% (3·6% incremental gain). AI detection tools decreased the discounted costs per screened individual from $3400 to $3343 (a saving of $57 per individual). Results were similar in the secondary analyses modelling once-in-life colonoscopy. At the US population level, the implementation of AI detection during screening colonoscopy resulted in yearly additional prevention of 7194 colorectal cancer cases and 2089 related deaths, and a yearly saving of US$290 million. Interpretation: Our findings suggest that implementation of AI detection tools in screening colonoscopy is a cost-saving strategy to further prevent colorectal cancer incidence and mortality.Item 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 Endoscopic treatments for early gastroesophageal lesions(AME, 2021) Srinivasan, Sachin; Hamade, Nour; Emura, Fabian; Sharma, Prateek; Medicine, School of MedicineGastroesophageal (GEJ) carcinoma is well-recognized since the 1970s and has shown 2.5-fold increase in incidence since then. There still exists much controversy and ambiguity in the literature about the occurrence and recurrence of these lesions post-treatment. This has been attributed to the variability in the terms and definitions used in these junctional lesions. Despite this, great strides have been made in the treatment of early lesions decreasing morbidity and mortality from surgical treatment options. The current modalities involve ablation [like radiofrequency, cryo or argon plasma coagulation (APC)] and/or resection [endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)] depending on the type and nature of lesion. These techniques are an effective tool demonstrating high rates of complete eradication of metaplasia or dysplasia (CE-IM/CE-D). It is crucial that the endoscopists are mindful about meticulous examination of the GEJ and Cardia as well as partake in appropriate surveillance post-endoscopic eradication. In addition, appropriate documentation of the location and type of lesion is also extremely important. This review aims to compare current endoscopic techniques in their efficacy, need for expertise and risk of complications when used in the treatment of early junctional lesions. Future studies and guideline recommendations to standardize definitions, diagnoses and post-treatment surveillance are needed.