The Burden of Overweight and Obesity-Associated Gastrointestinal Cancers in Low and Lower-Middle-Income Countries: A Global Burden of Disease 2019 Analysis.

INTRODUCTION: Obesity is associated with cancer, including gastrointestinal (GI). Data from low (LICs) and lower-middle-income countries (MICs) are limited. METHODS: We utilized data from the Global Burden of Disease Study 2019 to determine the mortality from GI cancer risk of high body mass index (BMI) in these countries. RESULTS: Mortality rates of GI cancers from high BMI increased in LICs and lower MICs, while burdens decreased or remained stable in high and middle-income countries. DISCUSSION: The GI cancer-related burden from high BMI increased in LICs and lower MICs, necessitating a concerted effort to tackle the obesity pandemic.

The Global Burden of Early-Onset Pancreatic Cancer and Its Risk Factors: A Perspective From Global Burden of Disease Study 2019.

OBJECTIVES: Despite evidence of increased incidence of early-onset pancreatic cancer (EOPC), defined as pancreatic cancer diagnosed in patients below 50 years old, and its risk factors in the Western region, global epidemiological data addressing this issue is still lacking. MATERIALS AND METHODS: Utilizing data from the Global Burden of Disease Study 2019, we aimed to conduct a comprehensive analysis of the incidence, deaths, and disability-adjusted life years (DALYs) associated with EOPC and its risk factors, including smoking, obesity, and diabetes. The analysis examined the annual percentage change (APC) over the period. RESULTS: In 2019, the incidence of EOPC surpassed 35,000 cases worldwide. This burden of EOPC tends to be more prevalent in males, as well as in Europe and high SDI countries. However, there is a noticeable upward trend in the burden of EOPC in the Eastern Mediterranean. While there is a global decline in EOPC mortality attributed to smoking (APC -0.33%), there is a concerning increase in mortality associated with diabetes (APC +2.84%) and obesity (APC +2.12%). CONCLUSIONS: The burden of EOPC has been increasing. The mortality is rising mainly from metabolic factors. There is an urgent need for national policy development for reducing the burden of this disease.

New window into hepatitis B in Africa: Liver sampling combined with single cell omics enables deep and longitudinal assessment of intrahepatic immunity in Zambia.

In Lusaka, Zambia, we introduced liver fine needle aspiration (FNA) into a research cohort of adults with treatment-naïve chronic hepatitis B virus (HBV) infection, with and without HIV coinfection, as well as with acute HBV infection. Over 117 enrollment and 47 longitudinal FNAs (at 1 year follow-up), we established participant acceptability and safety. We also demonstrated the quality of the material through single cell RNA sequencing of selected enrollment FNAs, which revealed a range of immune cells. This approach can drive new insights into HBV immunology, informing cure strategies, and can improve our understanding of HBV natural history in Africa.

Photon Absorption Remote Sensing Imaging of Breast Needle Core Biopsies Is Diagnostically Equivalent to Gold Standard H&E Histologic Assessment.

Photon absorption remote sensing (PARS) is a new laser-based microscope technique that permits cellular-level resolution of unstained fresh, frozen, and fixed tissues. Our objective was to determine whether PARS could provide an image quality sufficient for the diagnostic assessment of breast cancer needle core biopsies (NCB). We PARS imaged and virtually H&E stained seven independent unstained formalin-fixed paraffin-embedded breast NCB sections. These identical tissue sections were subsequently stained with standard H&E and digitally scanned. Both the 40× PARS and H&E whole-slide images were assessed by seven breast cancer pathologists, masked to the origin of the images. A concordance analysis was performed to quantify the diagnostic performances of standard H&E and PARS virtual H&E. The PARS images were deemed to be of diagnostic quality, and pathologists were unable to distinguish the image origin, above that expected by chance. The diagnostic concordance on cancer vs. benign was high between PARS and conventional H&E (98% agreement) and there was complete agreement for within-PARS images. Similarly, agreement was substantial (kappa > 0.6) for specific cancer subtypes. PARS virtual H&E inter-rater reliability was broadly consistent with the published literature on diagnostic performance of conventional histology NCBs across all tested histologic features. PARS was able to image unstained tissues slides that were diagnostically equivalent to conventional H&E. Due to its ability to non-destructively image fixed and fresh tissues, and the suitability of the PARS output for artificial intelligence assistance in diagnosis, this technology has the potential to improve the speed and accuracy of breast cancer diagnosis.

Investigating the Intersections of Racial Identity and Perceived Income Adequacy in Relation to Dietary Quality Among Adults in Canada.

BACKGROUND: Structural racism and economic marginalization shape dietary patterns in complex ways. Most research examining race and income inequities discount their interactions in shaping dietary intakes. An intersectional approach is needed to identify interconnected sources of social inequities and to more precisely locate dietary inequities. OBJECTIVES: We examined whether racial identity and perceived income adequacy independently and jointly shape dietary quality, defined using the Healthy Eating Index (HEI) 2015, among a large sample of adults in Canada. METHODS: Cross-sectional data from 2540 adults (≥18 years of age) in Canada who participated in the 2019 International Food Policy Study were analyzed. Multivariable linear regression models were executed to test the independent associations and interactions between racial identity and perceived income adequacy with HEI-2015 scores. Models were constructed to examine HEI-2015 total and component scores, adjusting for age, gender, and education. RESULTS: Perceived income adequacy, but not racial identity, was independently associated with HEI-2015 total scores. The interaction between racial identity and perceived income adequacy was significantly associated with HEI-2015 scores. Compared to the reference group (individuals identifying as White and reporting income adequacy), those identifying as Black and reporting income adequacy were associated with lower HEI-2015 scores (ß, -7.30; 95% CI, -13.07 to -1.54) and those identifying as Black and reporting income inadequacy were associated with lower HEI-2015 scores (ß, -6.37; 95% CI, -12.13 to -0.60). Individuals who identified as indigenous and reported neither income adequacy nor inadequacy had lower HEI-2015 scores (ß, -8.50; 95% CI, -13.82 to -3.18) compared to the reference group. CONCLUSIONS: Findings suggest that racial identity and perceived income adequacy jointly shape dietary quality. Inequities in dietary quality may be missed when intersecting racial identities and socioeconomic positions are not explicitly investigated. To support healthier dietary patterns, strategies must reduce socioeconomic barriers that impose dietary constraints on some racialized groups.

The Great Recession Index: A Place-based Indicator for Countries, States, and Metropolitan Areas.

The Great Recession (GR) of 2007-2009 marked the most devastating economic downturn since the Great Depression of the 1930s, and its consequences dramatically changed almost every aspect of social life. This research introduces the Great Recession Index (GRI), a place-based composite measure that captures the multidimensional nature of the GR. The GRI can be used to examine macro-level outcomes and is especially well-suited for examining the spatial variation and longterm effects of the GR. The GRI is adaptable to a variety of geospatial units of analysis, and in this article, we develop measures for countries, U.S. states, and U.S. metropolitan areas. Then, using the state-based GRI, we provide a research application to demonstrate the utility of the GRI for explaining state-level income inequality in the post-Recession period. The results show that the initial shock of the GR decreased the income share of upper-class households, but the aftershock of the Recession increased their income share, resulting in increased income inequality in the U.S. since the Recession. This paper concludes by considering the feasibility of using similar measures for evaluating the effects of catastrophic events such as wars, civil unrest, climate change, natural disasters, or pestilence on societal outcomes.

Artificial intelligence for the assessment of bowel preparation.

BACKGROUND AND AIMS: A reliable assessment of bowel preparation is important to ensure high-quality colonoscopy. Current bowel preparation scoring systems are limited by interobserver variability. This study aimed to demonstrate objective assessment of bowel preparation adequacy using an artificial intelligence (AI)/convolutional neural network (CNN) algorithm developed from colonoscopy videos. METHODS: Two CNNs were developed using a training set of 73,304 images from 200 colonoscopies. First, a binary CNN was developed and trained to distinguish video frames that were appropriate versus inappropriate for scoring with the Boston Bowel Preparation Scale (BBPS). A second multiclass CNN was developed and trained on 26,950 appropriate frames that were expertly annotated with BBPS segment scores (0-3). We validated the algorithm using 252 10-second video clips that were assigned BBPS segment scores by 2 experts. The algorithm provided mean BBPS scores based on the algorithm (AI-BBPS) by calculating mean BBPS based on each frame's scoring. We maximized the algorithm's performance by choosing a dichotomized AI-BBPS score that closely matched dichotomized BBPS scores (ie, adequate vs inadequate). We tested the mean BBPS score based on the algorithm AI-BBPS against human rating using 30 independent 10-second video clips (test set 1) and 10 full withdrawal colonoscopy videos (test set 2). RESULTS: In the validation set, the algorithm demonstrated an area under the curve of .918 and accuracy of 85.3% for detection of inadequate bowel cleanliness. In test set 1, sensitivity for inadequate bowel preparation was 100% and agreement between raters and AI was 76.7% to 83.3%. In test set 2, sensitivity for inadequate bowel preparation for each segment was 100% and agreement between raters and AI was 68.9% to 89.7%. Agreement between raters alone versus raters and AI were similar (κ = .694 and .649, respectively). CONCLUSIONS: The algorithm assessment of bowel cleanliness as measured with the BBPS showed good performance and agreement with experts including full withdrawal colonoscopies.

Survey Finds Gender Disparities Impact Both Women Mentors and Mentees in Gastroenterology.

INTRODUCTION: Gastroenterologists at all levels of practice benefit from formal mentoring. Much of the current literature on mentoring in gastroenterology is based on expert opinion rather than data. In this study, we aimed to identify gender-related barriers to successful mentoring relationships from the mentor and mentee perspectives. METHODS: A voluntary, web-based survey was distributed to physicians at 20 academic institutions across the United States. Overall, 796 gastroenterology fellows and faculty received the survey link, with 334 physicians responding to the survey (42% response rate), of whom 299 (90%; 129 women and 170 men) completed mentorship questions and were included in analysis. RESULTS: Responses of women and men were compared. Compared with men, more women preferred a mentor of the same gender (38.6% women vs 4.2% men, P < 0.0001) but less often had one (45.5% vs 70.2%, P < 0.0001). Women also reported having more difficulty finding a mentor (44.4% vs 16.0%, P < 0.0001) and more often cited inability to identify a mentor of the same gender as a contributing factor (12.8% vs 0.9%, P = 0.0004). More women mentors felt comfortable advising women mentees about work-life balance (88.3% vs 63.8%, P = 0.0005). Nonetheless, fewer women considered themselves effective mentors (33.3% vs 52.6%, P = 0.03). More women reported feeling pressured to mentor because of their gender (39.5% vs 0.9% of men, P < 0.0001). Despite no gender differences, one-third of respondents reported negative impact of the COVID-19 pandemic on their ability to mentor and be mentored. DISCUSSION: Inequities exist in the experiences of women mentees and mentors in gastroenterology, which may affect career advancement and job satisfaction.

Expert assessment on volumetric laser endomicroscopy full scans in Barrett's esophagus patients with or without high grade dysplasia or early cancer.

BACKGROUND: Volumetric laser endomicroscopy (VLE) allows for near-microscopic imaging of the superficial esophageal wall and may improve detection of early neoplasia in Barrett's esophagus (BE). Interpretation of a 6-cm long, circumferential VLE "full scan" may however be challenging for endoscopists. We aimed to evaluate the accuracy of VLE experts in correctly diagnosing VLE full scans of early neoplasia and non-dysplastic BE (NDBE). METHODS: 29 VLE full scan videos (15 neoplastic and 14 NDBE) were randomly evaluated by 12 VLE experts using a web-based module. Experts were blinded to the endoscopic BE images and histology. The 15 neoplastic cases contained a subtle endoscopically visible lesion, which on endoscopic resection showed high grade dysplasia or cancer. NDBE cases had no visible lesions and an absence of dysplasia in all biopsies. VLE videos were first scored as "neoplastic" or "NDBE." If neoplastic, assessors located the area most suspicious for neoplasia. Primary outcome was the performance of VLE experts in differentiating between non-dysplastic and neoplastic full scan videos, calculated by accuracy, sensitivity, and specificity. Secondary outcomes included correct location of neoplasia, interobserver agreement, and level of confidence. RESULTS: VLE experts correctly labelled 73 % (95 % confidence interval [CI] 67 % - 79 %) of neoplastic VLE videos. In 54 % (range 27 % - 66 %) both neoplastic diagnosis and lesion location were correct. NDBE videos were consistent with endoscopic biopsies in 52 % (95 %CI 46 % - 57 %). Interobserver agreement was fair (kappa 0.28). High level of confidence was associated with a higher rate of correct neoplastic diagnosis (81 %) and lesion location (73 %). CONCLUSIONS: Identification of subtle neoplastic lesions in VLE full scans by experts was disappointing. Future studies should focus on improving methodologies for reviewing full scans, development of refined VLE criteria for neoplasia, and computer-aided diagnosis of VLE scans.

COVID-19 polymerase chain reaction testing before endoscopy: an economic analysis.

BACKGROUND AND AIMS: The novel coronavirus disease 2019 (COVID-19) pandemic has limited endoscopy utilization, causing significant health and economic losses. We aim to model the impact of polymerase chain reaction (PCR) testing into resuming endoscopy practice. METHODS: We performed a retrospective review of endoscopy utilization during the COVID-19 pandemic for a baseline reference. A computer model compared 3 approaches: strategy 1, endoscopy for urgent indications only; strategy 2, testing for semiurgent indications; and strategy 3, testing all patients. Analysis was made under current COVID-19 prevalence and projected prevalence of 5% and 10%. Primary outcomes were number of procedures performed and/or canceled. Secondary outcomes were direct costs, reimbursement, personal protective equipment used, and personnel infected. Disease prevalence, testing accuracy, and costs were obtained from the literature. RESULTS: During the COVID-19 pandemic, endoscopy volume was 12.7% of expected. Strategies 2 and 3 were safe and effective interventions to resume endoscopy in semiurgent and elective cases. Investing 22 U.S. dollars (USD) and 105 USD in testing per patient allowed the completion of 19.4% and 95.3% of baseline endoscopies, respectively. False-negative results were seen after testing 4700 patients (or 3 months of applying strategy 2 in our practice). Implementing PCR testing over 1 week in the United States would require 13 and 64 million USD, with a return of 165 and 767 million USD to providers, leaving 65 and 325 healthcare workers infected. CONCLUSIONS: PCR testing is an effective strategy to restart endoscopic practice in the United States. PCR screening should be implemented during the second phase of the pandemic, once the healthcare system is able to test and isolate all suspected COVID-19 cases.

Valuing innovative endoscopic techniques: prophylactic clip closure after endoscopic resection of large colon polyps.

BACKGROUND AND AIMS: Clip closure of the mucosal defect after resecting large (≥20 mm) nonpedunculated colorectal polyps reduces postprocedure bleeding and is cost saving for payers. Clip costs are not reimbursed by payers, posing a major barrier to adoption of this technique in the community. We aimed to determine appropriate clip costs to support broader use of this procedure in practice. METHODS: We performed budget impact analysis using our recent decision analytic model, comparing prophylactic clip closure with no clip closure on national cost and outcomes data, to determine the maximum feasible clip price while maintaining cost savings in practice. Sensitivity analyses were performed on important clinical factors. RESULTS: In the original model, the baseline postprocedure bleeding risk was 6.8%, increasing cost of care by $614.11 averaged among all patients undergoing large polyp resection without clip closure. Prophylactic clip closure of only large right-sided polyps reduced postprocedure bleeding risk by 70.7% but resulted in cost saving only if the price of clips was $100 or less. Comparatively, prophylactic clip closure of large left-sided polyps had no clinical benefit and was not cost saving. Clip closure strategies focused only on extra-large polyps (≥40 mm), or patients taking antithrombotics regardless of polyp characteristics, were only minimally cost saving. Cost savings and maximum tolerated clip prices depended on medical comorbidity, which directly influences the costs of care to manage postprocedure bleeding. CONCLUSIONS: Prophylactic clip closure after endoscopic resection of large colon polyps, particularly those in the right colon segment, is cost saving but requires clip costs less than $100. Translating these findings into practice requires gastroenterology practices to obtain reimbursement from payers for improved clinical outcomes and to align commercial clip prices with this clinical indication.

Degrees of inequality: The Great Recession and the college earnings premium in U.S. metropolitan areas.

The Great Recession had devastating effects on the U.S. labor market as millions of workers lost their jobs while others faced declining earnings, erosion of job security, and loss of dignity at work. While workers of all education levels experienced rising unemployment and declining earnings, it is unclear if workers of all educational levels were equally affected. In this paper, we examine the impact of the Great Recession on variations in the college earnings premium-the ratio of earnings for workers with just four-year college degrees to those with just high school degrees-for 210 metropolitan statistical areas from 2007 to 2016. Using multilevel growth curve models, we find that the college earnings premium increased during the Great Recession and its aftermath and that metropolitan areas that experienced more severe disruptions from the Great Recession evidenced greater increases in the college earnings premium. This is mainly explained by much sharper declines in earnings of workers with high school degrees than those with college degrees.

Cost effectiveness of endoscopic gallbladder drainage to treat acute cholecystitis in poor surgical candidates.

BACKGROUND: Endoscopic gallbladder drainage (GBD) is an alternative to percutaneous GBD (PGBD) to treat acute cholecystitis, yielding similar success rates and fewer adverse events. To our knowledge, no cost-effectiveness analysis has compared these procedures. We performed an economic analysis to identify clinical and cost determinants of three treatment options for acute cholecystitis in poor surgical candidates. METHODS: We compared three treatment strategies: PGBD, endoscopic retrograde cholangiographic transpapillary drainage (ERC-GBD), and endosonographic GBD (EUS-GBD). A decision tree was created over a 3-month period. Effectiveness was measured using hospital length of stay, including adverse events and readmissions. Costs of care were calculated from the National Inpatient Sample. Technical and clinical success estimates were obtained from the published literature. Cost effectiveness was measured as incremental cost effectiveness and compared to the national average cost of one hospital bed per diem. RESULTS: Analysis of a hypothetical cohort of poor candidates for cholecystectomy showed that, compared to PGBD, ERC-GBD was a cost-saving strategy and EUS-GBD was cost effective, requiring $1312 per hospitalization day averted. Additional costs of endoscopic interventions were less than the average cost of one hospital bed per diem. Compared to ERC-GBD, EUS-GBD required expending an additional $8950 to prevent one additional day of hospitalization. Our model was considerably affected by lumen-apposing metal stent cost and hospital length of stay for patients managed conservatively and those requiring delayed surgery. CONCLUSIONS: Endoscopic GBD is cost effective compared to PGBD, favoring ERC-GBD over EUS-GBD. Further efforts are needed to make endoscopic GBD available in more medical centers, reduce equipment costs, and shorten inpatient stay.

Cost-effectiveness of Pancreatic Cancer Surveillance in High-Risk Individuals: An Economic Analysis.

OBJECTIVE: The aim of the study was to perform an economic analysis to identify the clinical and cost determinants of pancreatic cancer (PC) surveillance in high-risk individuals (HRIs). METHODS: A Markov model was created to compare the following 3 strategies: no screening, endoscopic ultrasound (EUS), and magnetic resonance imaging (MRI) screening. Patients were considered HRIs according to the Cancer of the Pancreas Screening consortium recommendations. Risk for developing PC, survival, and costs data were obtained from the Surveillance, Epidemiology, and End Results and Medicare databases. Surveillance effectiveness was obtained from a recent meta-analysis. RESULTS: Analysis of a cohort with fivefold relative risk of PC higher than the US population showed that MRI is the most cost-effective strategy. For those with the highest risk (>×20 relative risk), EUS became the dominant strategy. Our model was impacted by cost and imaging performance, but still cost-effective within the range reported in literature. Threshold analysis showed that if MRI increases greater than US $1600, EUS becomes more cost-effective. Once patients reached the age of 76 years, "no screening" was favored. Both surveillance strategies were cost-effective over a wide range of willingness to pay. CONCLUSIONS: Abdominal imaging followed by pancreatectomy is cost-effective to prevent PC in HRIs, favoring MRI in moderate risk cases but EUS in those with highest risk.

Endoscopic scar assessment after colorectal endoscopic mucosal resection scars: when is biopsy necessary (EMR Scar Assessment Project for Endoscope (ESCAPE) trial).

OBJECTIVE: It is unclear whether endoscopic assessment of scars after colorectal endoscopic mucosal resection (EMR) has to include biopsies, even if endoscopy is negative. Vice versa, endoscopic diagnosis of recurrent adenoma may not require biopsy before endoscopic reinterventions. We prospectively analysed various endoscopic modalities in the diagnosis of recurrence following EMR. DESIGN: We conducted a prospective study of patients undergoing colonoscopy after EMR of large (≥20 mm) colorectal neoplasia. Endoscopists predicted recurrence and confidence level with four imaging modes: high-definition white light (WL) and narrow-band imaging (NBI) with and without near focus (NF). Separately, 26 experienced endoscopists assessed offline images. RESULTS: Two hundred and thirty patients with 255 EMR scars were included. The prevalence of recurrent adenoma was 24%. Diagnostic values were high for all modes (negative predictive value (NPV) ≥97%, positive predictive value (PPV) ≥81%, sensitivity ≥90%, specificity ≥93% and accuracy ≥93%). In high-confidence cases, NBI with NF had NPV of 100% (95% CI 98% to 100%) and sensitivity of 100% (95% CI 93% to 100%). Use of clips at initial EMR increased diagnostic inaccuracy (adjusted OR=1.68(95% CI 1.01 to 2.75)). In offline assessment, specificity was high for all imaging modes (mean: ≥93% (range: 55%-100%)), while sensitivity was significantly higher for NBI-NF (82%(72%-93%)%)) compared with WL (69%(38%-86%); p<0.001), WL-NF (68%(55%-83%); p<0.001) and NBI (71%(59%-90%); p<0.001). CONCLUSION: Our study demonstrates very high sensitivity and accuracy for all four imaging modalities, especially NBI with NF, for diagnosis of recurrent neoplasia after EMR. Our data strongly suggest that in cases of high confidence negative optical diagnosis based on NBI-NF, no biopsy is needed to confirm absence of recurrence during colorectal EMR follow-up. A high confidence positive optical diagnosis can lead to immediate resection of any suspicious area. In all cases of low confidence, biopsy is still required. TRIAL REGISTRATION NUMBER: NCT02668198.

Optimal Management of Malignant Polyps, From Endoscopic Assessment and Resection to Decisions About Surgery.

Colorectal cancer is defined clinically as invasion of dysplastic cells into the submucosa. Lesions with submucosal invasion but without invasion into the muscularis propria are generally called malignant polyps. A stepwise approach produces optimal management of malignant polyps (including polypoid and flat/depressed lesions). The first step is to avoid endoscopic resection of non-pedunculated lesions with endoscopic features that predict deep submucosal invasion. Lesions without such features are candidates for endoscopic resection. The second step is to assess candidates for endoscopic resection for features that predict an increased risk of superficial submucosal invasion. Such lesions should be considered for en bloc endoscopic excision if feasible. The third step is giving patients with endoscopically resected malignant polyps good advice regarding whether to undergo adjuvant therapy, usually surgery. We review the endoscopic and histologic criteria that guide clinicians through these steps.

Model assessment in dynamic treatment regimen estimation via double robustness.

Dynamic treatment regimens (DTRs) recommend treatments based on evolving subject-level data. The optimal DTR is that which maximizes expected patient outcome and as such its identification is of primary interest in the personalized medicine setting. When analyzing data from observational studies using semi-parametric approaches, there are two primary components which can be modeled: the expected level of treatment and the expected outcome for a patient given their other covariates. In an effort to offer greater flexibility, the so-called doubly robust methods have been developed which offer consistent parameter estimators as long as at least one of these two models is correctly specified. However, in practice it can be difficult to be confident if this is the case. Using G-estimation as our example method, we demonstrate how the property of double robustness itself can be used to provide evidence that a specified model is or is not correct. This approach is illustrated through simulation studies as well as data from the Multicenter AIDS Cohort Study.

Endoscopic resection is cost-effective compared with laparoscopic resection in the management of complex colon polyps: an economic analysis.

BACKGROUND AND AIMS: Endoscopic resection (ER) is an efficacious treatment for complex colon polyps (CCPs). Many patients are referred for surgical resection because of concerns over procedural safety, incomplete polyp resection, and adenoma recurrence after ER. Efficacy data for both resection strategies are widely available, but a paucity of data exist on the cost-effectiveness of each modality. The aim of this study was to perform an economic analysis comparing ER and laparoscopic resection (LR) strategies in patients with CCP. METHODS: A decision analysis tree was constructed using decision analysis software. The 2 strategies (ER vs LR) were evaluated in a hypothetical cohort of patients with CCPs. A hybrid Markov model with a 10-year time horizon was used. Patients entered the model after colonoscopic diagnosis at age 50. Under Strategy I, patients underwent ER followed by surveillance colonoscopy at 3 to 6 months and 12 months. Patients with failed ER and residual adenoma at 12 months were referred for LR. Under Strategy II, patients underwent LR as primary treatment. Patients with invasive cancer were excluded. Estimates regarding ER performance characteristics were obtained from a systematic review of published literature. The Centers for Medicare & Medicaid Services (2012-2013) and the 2012 Healthcare Cost and Utilization Project databases were used to determine the costs and loss of utility. We assumed that all procedures were performed with anesthesia support, and patients with adverse events in both strategies required inpatient hospitalization. Baseline estimates and costs were varied by using a sensitivity analysis through the ranges. RESULTS: LR was found to be more costly and yielded fewer quality-adjusted life-years (QALYs) compared with ER. The cost of ER of a CCP was $5570 per patient and yielded 9.640 QALYs. LR of a CCP cost $18,717 per patient and yielded fewer QALYs (9.577). For LR to be more cost-effective, the thresholds of 1-way sensitivity analyses were (1) technical success of ER for complete resection in <75.8% of cases, (2) adverse event rates for ER > 12%, and (3) LR cost of <$14,000. CONCLUSIONS: Our data suggest that ER is a cost-effective strategy for removal of CCPs. The effectiveness is driven by high technical success and low adverse event rates associated with ER, in addition to the increased cost of LR.

Transarterial hepatic chemoembolization with 70-150 µm drug-eluting beads: assessment of clinical safety and liver toxicity profile.

PURPOSE: To assess the incidence and severity of adverse events (AEs) in the form of clinical symptoms and liver/biliary injuries (LBI) in patients with hepatic malignancies treated with transarterial chemoembolization using 70-150 µm drug-eluting beads (DEBs). MATERIALS AND METHODS: A single-institution retrospective analysis was performed in 37 patients (25 patients with hepatocellular carcinoma and 12 patients with metastatic disease) who underwent 43 sessions of segmental/subsegmental 70-150 µm DEB transarterial chemoembolization with doxorubicin (38 sessions) or irinotecan (5 sessions). Patient inclusion criteria included the presence of the following lesion features: small diameter (≤ 3 cm), hypovascular, or with areas of residual disease after other locoregional therapies. Mean tumor diameter was 3.4 cm. Mean imaging and clinical follow-up periods were 171 days and 373 days, respectively. Clinical, laboratory, and imaging data were used to identify and classify clinically symptomatic AEs per session and LBI per patient according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. Predictors for the occurrence of LBI were evaluated by logistic regression analysis. RESULTS: No grade 4 or 5 AEs were recorded. Clinically symptomatic AEs occurred in 29 (67.4%) sessions (grade 1-2, 28 sessions; grade 3, 1 session), all constituting postembolization syndrome. Asymptomatic LBI occurred in 11 (29.7%) patients (grade 1, 8 patients; grade 2, 3 patients). The mean time between 70-150 µm DEB transarterial chemoembolization session and appearance of LBI was 71 days (range, 21-223 d). No predictive factors for the development of LBI were identified. CONCLUSIONS: Transarterial chemoembolization with 70-150 µm DEBs was considered safe in the present study population given the acceptably low incidence and severity of AEs.

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.