Structured training program on confocal laser endomicroscopy for pancreatic cystic lesions: a multicenter prospective study among early-career endosonographers (with video).

BACKGROUND AND AIMS: Data on how to teach endosonographers needle-based confocal laser endomicroscopy (nCLE)-guided histologic diagnosis of pancreatic cystic lesions (PCLs) are limited. Hence, we developed and tested a structured educational program to train early-career endosonographers in nCLE-guided diagnosis of PCLs. METHODS: Twenty-one early-career nCLE-naïve endosonographers watched a teaching module outlining nCLE criteria for diagnosing PCLs. Participants then reviewed 80 high-yield nCLE videos, recorded diagnoses, and received expert feedback (phase 1). Observers were then randomized to a refresher feedback session or self-learning at 4 weeks. Eight weeks after training, participants independently assessed the same 80 nCLE videos without feedback and provided histologic predictions (phase 2). Diagnostic performance of nCLE to differentiate mucinous versus nonmucinous PCLs and to diagnose specific subtypes were analyzed using histopathology as the criterion standard. Learning curves were determined using cumulative sum analysis. RESULTS: Accuracy and diagnostic confidence for differentiating mucinous versus nonmucinous PCLs improved as endosonographers progressed through nCLE videos in phase 1 (P < .001). Similar trends were observed with the diagnosis of PCL subtypes. Most participants achieved competency interpreting nCLE, requiring a median of 38 assessments (range, 9-67). During phase 2, participants independently differentiated PCLs with high accuracy (89%), high confidence (83%), and substantial interobserver agreement (κ = .63). Accuracy for nCLE-guided PCL subtype diagnoses ranged from 82% to 96%. The learned nCLE skills did not deteriorate at 8 weeks and were not impacted by a refresher session. CONCLUSIONS: We developed a practical, effective, and durable educational intervention to train early-career endosonographers in nCLE-guided diagnosis of PCLs.

Endoscopic Retrograde Cholangiopancreatography Performed by Trainees Is Not Associated with Increased Immediate Adverse Events or Technical Failure Rates.

BACKGROUND/AIM: Training endoscopists to perform endoscopic retrograde cholangiopancreatography (ERCP) is critical to address the increasing patient population with pancreatobiliary diseases. Concerns remain about ERCP safety and success involving trainees. We compared the technical success and immediate adverse events between ERCP with and without trainee involvement. METHODS: Retrospective analysis of 28,271 ERCP procedures in a national sample of the United States over 12 years. Demographics, procedure and fluoroscopy time, visualization and cannulation of main structures, adverse events, and technical success rates were compared between ERCP with and without trainees. Categorical variables were compared using Pearson's chi-square test and continuous variables using a standard t-test. Univariate and multivariate regressions were performed adjusting for age, gender, ethnicity, US region, ASA class and clinical setting. RESULTS: Approximately 49.5% of ERCPs had a trainee involved. The ampulla was visualized in 97.4% with trainee vs. 97.3% without trainee involvement (P = 0.858). The common bile duct was visualized and cannulated in 90.4% with trainees vs. 91.7% without trainees involved (P < 0.001). The ERCP was incomplete in 5.9% of cases with trainees vs. 6.4% without trainees involved (P = 0.207). Trainee participation added 8.7 min to average procedure time (aOR: 1.02, P < 0.001) and 2.0 min to fluoroscopy time (aOR: 1.00, P = 0.796). Adverse events (aOR: 0.89, P = 0.704) and technical success (aOR: 0.83, P = 0.571) were similar in both groups. CONCLUSIONS: Trainee involvement leads to increased procedure duration but is not associated with increased immediate adverse events, or technical failure. Our study supports ERCP safety and success with trainee participation.

Pancreatic Disorders in Patients with Inflammatory Bowel Disease.

Inflammatory bowel disease (IBD) can involve multiple organ systems, and pancreatic manifestations of IBD are not uncommon. The incidence of several pancreatic diseases is more frequent in patients with Crohn's disease and ulcerative colitis than in the general population. Pancreatic manifestations in IBD include a heterogeneous group of disorders and abnormalities ranging from mild, self-limited disorders to severe diseases. Asymptomatic elevation of amylase and/or lipase is common. The risk of acute pancreatitis in patients with IBD is increased due to the higher incidence of cholelithiasis and drug-induced pancreatitis in this population. Patients with IBD commonly have altered pancreatic histology and chronic pancreatic exocrine dysfunction. Diagnosing acute pancreatitis in patients with IBD is challenging. In this review, we discuss the manifestations and possible causes of pancreatic abnormalities in patients with IBD.

The Increasing Proportion of Early-Stage Pancreatic Cancer between 2004-2013: A SEER Analysis.

Pancreatic cancer will become the second leading cause of cancer-related death in the United States by 2030. Survival improves when it is identified at an early-stage and resected. Increasing public attention and cross-section imaging may shift detection to earlier stages. We found a small total increase in the proportion of stage-I cancer relative to all stages and a significant increase compared to distant disease in the Surveillance, Epidemiology, and End Results (SEER) database. Despite this, our ability to screen and identify early-stage disease is still lacking. Additional research and population-based interventions are necessary to improve early detection.

Thirty-Day Readmission Among Patients with Alcoholic Acute Pancreatitis.

BACKGROUND/OBJECTIVES: Alcoholic acute pancreatitis (AAP) comprises the second most common cause of acute pancreatitis in the USA, and there is lack of data regarding 30-day specific readmission causes and predictors. We aim to identify 30-day readmission rate, causes, and predictors of readmission. METHODS: Retrospective analysis of the 2016 National Readmission Database of adult patients readmitted within 30 days after an index admission for AAP. RESULTS: Totally, 76,609 AAP patients were discharged from the hospital in 2016. The 30-day readmission rate was 12%. The main cause of readmission was another episode of AAP. Readmission was not associated with higher mortality (1.3% vs. 1.2%; P = 0.21) or prolonged length of stay (5.2 vs. 5.0 days; P = 0.06). The total health care economic burden was $354 million in charges and $90 million in costs. Independent predictors of readmission were having Medicaid insurance, a Charlson comorbidity index score ≥ 3, use of total parenteral nutrition, opioid abuse disorder, prior pancreatic cyst, chronic alcoholic pancreatitis, and other chronic pancreatitis. Obesity was associated with lower odds of readmission. CONCLUSION: Readmission rate for AAP is high and its primary cause are recurrent episodes of AAP. Alcohol and substance abuse pose a high burden on our health care system. Public health strategies should be targeted to provide alcohol abuse disorder rehabilitation and cessation resources to alleviate the burden on readmission, the health care system and to improve patient outcomes.

Increased Incidence and Mortality of Gastric Cancer in Immigrant Populations from High to Low Regions of Incidence: A Systematic Review and Meta-Analysis.

BACKGROUND & AIMS: Gastric cancer is the leading cause of infection-related cancer death and the third-leading cause of cancer death worldwide. The effect of immigration on gastric cancer risk is not well-defined but might be helpful for screening or surveillance endeavors. We performed a systematic review and meta-analysis to define the risk of gastric cancer in immigrants from high-incidence regions to low-incidence regions (including Western Europe, Australia, Brazil, Canada, Israel, and the United States). METHODS: We searched MEDLINE and EMBASE databases, from January 1980 to January 2019, for studies that identified immigrants from high-incidence regions of gastric cancer, provided clear definitions of immigrant and reference populations, and provided sufficient data to calculate gastric cancer incidence and gastric cancer-related mortality. We performed meta-analyses of standardized incidence ratios (SIR) for first-generation immigrants from high- to low-incidence regions, stratified by immigrant generation, sex, and anatomic and histologic subtype, when data were available. RESULTS: We identified 38 cohort studies that met our inclusion criteria. All 13 studies of 21 distinct populations reported significantly increased SIRs for gastric cancer in first-generation foreign-born immigrants (men SIR range, 1.24-4.50 and women SIR range, 1.27-5.05). The pooled SIR for immigrants with all types of gastric cancer was 1.66 (95% CI, 1.52-1.80) for men and 1.83 (95% CI, 1.69-1.98) for women. Nine studies from 2 high-incidence populations (the former Soviet Union and Japan) reported an increased gastric cancer standardized mortality ratio in first-generation immigrants who migrated to regions of low incidence (former Soviet Union immigrants, 1.44-1.91 for men and 1.40-2.56 for women). CONCLUSIONS: Immigrants from regions with a high incidence of gastric cancer to regions of low incidence maintain a higher risk of gastric cancer and related mortality, based on a comprehensive systematic review and meta-analysis. Assessment of immigrant generation along with other risk factors might help identify high-risk populations for prevention and therapeutic interventions.

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.

Diagnostic Yield From Screening Asymptomatic Individuals at High Risk for Pancreatic Cancer: A Meta-analysis of Cohort Studies.

BACKGROUND & AIMS: There have been few studies of abdominal imaging screening of individuals at high risk for pancreatic cancer (based on family history or genetic variants). We performed a meta-analysis of prospective cohort studies to determine the diagnostic yield and outcomes of abdominal imaging screening for asymptomatic individuals at high risk. METHODS: Through a systematic review of multiple electronic databases and conference proceedings through July 2017, we identified prospective cohort studies (>20 patients) of asymptomatic adults determined to be at high-risk of pancreatic cancer (lifetime risk >5%, including specific genetic-associated conditions) who were screened by endoscopic ultrasound (EUS) and/or magnetic resonance imaging (MRI) to detect pancreatic lesions. Our primary outcome was identification of high-risk pancreatic lesions (high-grade pancreatic intraepithelial neoplasia, high-grade dysplasia, or adenocarcinoma) at initial screening, and overall incidence during follow up. Summary estimates were reported as incidence rates per 100 patient-years. RESULTS: We identified 19 studies comprising 7085 individuals at high risk for pancreatic cancer; of these, 1660 patients were evaluated by EUS and/or MRI. Fifty-nine high-risk lesions were identified (43 adenocarcinomas: 28 during the initial exam and 15 during follow-up surveillance) and 257 patients underwent pancreatic surgery. Based on our meta-analysis, the overall diagnostic yield screening for high-risk pancreatic lesions was 0.74 (95% CI, 0.33-1.14), with moderate heterogeneity among studies. The number needed to screen to identify 1 patient with a high-risk lesion was 135 (95% CI, 88-303). The diagnostic yield was similar for patients with different genetic features that increased risk, and whether patients were screened by EUS or MRI. CONCLUSIONS: Based on meta-analysis, 135 patients at high-risk for pancreatic cancer must be screened to identify 1 patient with a high-risk pancreatic lesion. Further studies are needed to determine whether screening reduces mortality and is cost effectiveness for individuals at high-risk of pancreatic cancer.

Esophageal Food Impaction: Causes, Elective Intubation, and Associated Adverse Events.

GOALS: The goal of this study is to examine the causes, type of adverse events (AE), and effects of elective intubation in outcomes associated with esophageal food impaction (EFI). BACKGROUND: EFI is a gastrointestinal emergency requiring immediate medical attention. STUDY: Retrospective review of all EFI cases presenting at 3 large tertiary centers from October 1, 2011 to October 31, 2014 and all cases registered in the Clinical Outcome Research Initiative (CORI) database from January 1, 2000 to December 31, 2012. Statistical analysis compared health care utilization, AEs, and outcomes in patients with or without elective intubation. RESULTS: A total of 214 cases presenting with EFI at our 3 referral hospitals and 4950 cases in the CORI database met inclusion criteria. Prevalence of structural disorders was similar in the Mayo Clinic and CORI datasets: 24.3% and 27.7% had strictures, and 3.8% and 2.5% had a tumor, respectively. AEs in the nonintubation group were 14.7% compared with 33.3% in the elective intubation group (P=0.003); however, 71.0% of these events were associated with EFI itself and not therapeutic procedure. Esophageal AEs were common (15.0%), followed by pulmonary and cardiovascular events with 3.0% and 1.4%, respectively. Severity of the AEs was influenced by the impaction-to-endoscopy time. CONCLUSIONS: Prevalence of structural esophageal disorders was similar to previous smaller studies. Elective intubation was associated with increased AEs; however, this is felt to be because of the nature of EFI itself and not by therapeutic endoscopy. Prolonged impaction-to-endoscopy time was associated with severe AEs.

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.

Volumetric laser endomicroscopy in the biliary and pancreatic ducts: a feasibility study with histological correlation.

BACKGROUND: Volumetric laser endomicroscopy (VLE) provides circumferential images 3 mm into the biliary and pancreatic ducts. We aimed to correlate VLE images with the normal and abnormal microstructure of these ducts. METHODS: Samples from patients undergoing hepatic or pancreatic resection were evaluated. VLE images were collected using a low-profile VLE catheter inserted manually into the biliary and pancreatic ducts ex vivo. Histological correlation was assessed by two unblinded investigators. RESULTS: 25 patients (20 liver and 5 pancreatic samples) and 111 images were analyzed. VLE revealed three histological layers: epithelium, connective tissue, and parenchyma. It identified distinctive patterns for primary sclerosing cholangitis (PSC), pancreatic cysts, neuroendocrine tumor, and adenocarcinoma adjacent to the pancreatic duct or ampulla. VLE failed to identify dysplasia in a dominant stricture and inflammatory infiltrates in PSC. Reflectivity measurements of the liver parenchyma diagnosed liver cirrhosis with high sensitivity. CONCLUSIONS: VLE can identify histological changes in the biliary and pancreatic ducts allowing real-time diagnosis. Further studies are needed to measure the accuracy of VLE in a larger sample and to validate our findings in vivo.

Mallory Weiss syndrome is not associated with hiatal hernia: a matched case-control study.

BACKGROUND/OBJECTIVE: Hiatal hernia is considered to be a predisposing factor to develop Mallory-Weiss Syndrome (MWS). No large case-control studies verifying this hypothesis have been conducted. METHODS: We reviewed all esophagogastroduodenoscopies with findings of MWS (n = 2342) in a national database and compared with age and gender-matched controls (n = 9368). Demographics, endoscopic characteristics and presence of a hiatal hernia were compared between both groups. Average age was 56.7 ± 18.6 years, and 72.4% were male. RESULTS: Hiatal hernia was more common in controls, and no significant difference was seen in a multivariate analysis. CONCLUSION: Dynamic changes inducing mucosal tension are more relevant determinants to develop MWS than gastro-esophageal junction location alone.

Characteristics of illegal and legal cigarette packs sold in Guatemala.

BACKGROUND: Guatemala, as a party to the Framework Convention on Tobacco Control (FCTC), is required to regulate cigarette packaging and labeling and eliminate illicit tobacco trade. Current packaging and labeling characteristics (of legal and illegal cigarettes) and their compliance with the FCTC is unknown. METHODS: We sought to analyze package and label characteristics of illegal and legal cigarettes sold in Guatemala. We visited the 22 largest traditional markets in the country to purchase illegal cigarettes. All brands registered on tobacco industry websites were purchased as legal cigarettes. Analysis compared labeling characteristics of illegal and legal packs. FINDINGS: Most (95%) markets and street vendors sold illegal cigarettes; 104 packs were purchased (79 illegal and 25 legal). Ten percent of illegal and none of the legal packs had misleading terms. Half of the illegal packs had a warning label covering 26 to 50% of the pack surface. All legal packs had a label covering 25% of the surface. Illegal packs were more likely to have information on constituents and emissions (85% vs. 45%, p < 0.001) and were less expensive than legal ones (USD 0.70 ± 0.7 and 1.9 ± 1.8, p < 0.001). CONCLUSIONS: In Guatemala, neither illegal nor legal cigarette packs comply with FCTC labeling mandates. Urgent implementation and enforcement of the FCTC is necessary to halt the tobacco epidemic.