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.

Splenic injury is an under-recognized adverse event of in-patient colonoscopy: a nationwide analysis.

Background and study aims Splenic injury (SI) during colonoscopy is an underappreciated adverse event. Our aim was to examine the occurrence and outcomes of patients who developed SI after inpatient colonoscopy using a nationwide dataset. Patients and methods Retrospective, observational study using the National Inpatient Sample (NIS) between 2012 and 2018. All patients with ICD9/10CM procedural codes for colonoscopy with or without SI were included. The primary outcome was the association between SI and inpatient colonoscopy. Secondary outcomes were inpatient morbidity, mortality, resource utilization, splenectomy rates, hospital length of stay and total hospital costs and charges. Comparative analyses were performed between patients with and without SI. Multivariate regression analyses were utilized. Results A total of 2,258,040 of inpatient colonoscopies were included. Of these, 240 had associated SI and 25 patients required splenectomy (10.4 %). The incidence of colonoscopy-associated SI remained relatively stable between 2012 and 2018 (0.033 % versus 0.020 %, respectively). The mean age of patients with and without SI was 63.7 and 64.1 years, respectively. The occurrence of SI was calculated as 10.63 cases per 100,000 inpatient colonoscopies. Patients who had associated SI displayed significantly higher odds of inpatient mortality (aOR: 14.45) and ICU stay (aOR: 10.11) compared to those without SI. Conclusions Splenic injury confers significantly higher odds of inpatient mortality, and resource utilization. The incidence of SI related to colonoscopy remained stable during the study period. Although uncommon, SI should be considered when encountering patients with abdominal pain after colonoscopy.

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.

Confocal Laser Endomicroscopy in the Diagnosis of Biliary and Pancreatic Disorders: A Systematic Analysis.

BACKGROUND/AIMS: Endoscopic visualization of the microscopic anatomy can facilitate the real-time diagnosis of pancreatobiliary disorders and provide guidance for treatment. This study aimed to review the technique, image classification, and diagnostic performance of confocal laser endomicroscopy (CLE). METHODS: We conducted a systematic review of CLE in pancreatic and biliary ducts of humans, and have provided a narrative of the technique, image classification, diagnostic performance, ongoing research, and limitations. RESULTS: Probe-based CLE differentiates malignant from benign biliary strictures (sensitivity, ≥89%; specificity, ≥61%). Needlebased CLE differentiates mucinous from non-mucinous pancreatic cysts (sensitivity, 59%; specificity, ≥94%) and identifies dysplasia. Pancreatitis may develop in 2-7% of pancreatic cyst cases. Needle-based CLE has potential applications in adenocarcinoma, neuroendocrine tumors, and pancreatitis (chronic or autoimmune). Costs, catheter lifespan, endoscopist training, and interobserver variability are challenges for routine utilization. CONCLUSION: CLE reveals microscopic pancreatobiliary system anatomy with adequate specificity and sensitivity. Reducing costs and simplifying image interpretation will promote utilization by advanced endoscopists.

Western Honduras Copán Population-Based Cancer Registry: Initial Estimates and a Model for Rural Central America.

PURPOSE: Population-based cancer registries (PBCRs) are critical for national cancer control planning, yet few low- and middle-income countries (LMICs) have quality PBCRs. The Central America Four region represents the principal LMIC region in the Western hemisphere. We describe the establishment of a PBCR in rural Western Honduras with first estimates for the 2013-2017 period. METHODS: The Western Honduras PBCR was established through a collaboration of academic institutions and the Honduras Ministry of Health for collection of incident cancer data from public and private health services. Data were recorded using the Research Electronic Data Capture (REDCap) web-based platform with data monitoring and quality checks. Crude and age-standardized rates (ASRs) were calculated at the regional level, following WHO methodology. RESULTS: The web-based platform for data collection, available ancillary data services (eg, endoscopy), and technical support from international centers (United States and Colombia) were instrumental for quality control. Crude cancer incidence rates were 112.2, 69.8, and 154.6 per 100,000 habitants overall, males, and females, respectively (excluding nonmelanoma skin cancer). The adjusted ASRs were 84.2, 49.6, and 118.9 per 100,000 overall habitants, males, and females, respectively. The most common sites among men were stomach (ASR 26.0, 52.4%), colorectal (ASR 5.11, 10.15%), and prostate (ASR 2.7, 5.4%). The most common sites in women were cervix (ASR 34.2, 36.7%), breast (ASR 11.2, 12.3%), and stomach (ASR 10.8, 11.7%). CONCLUSION: The Copán-PBCR represents a successful model to develop cancer monitoring in rural LMICs. Innovations included the use of the REDCap platform and leverage of Health Ministry resources. This provides the first PBCR data for Honduras and the Central America Four and confirms that infection-driven cancers, such as gastric and cervical, should be priority targets for cancer control initiatives.

Impact of supine versus prone position on endoscopic retrograde cholangiopancreatography performance: a retrospective study.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is frequently performed in the prone or supine position. We compared the technical success and other outcomes between these positions. METHODS: This was a retrospective cohort study using the Clinical Outcomes Research Initiative database. Demographics, procedure and fluoroscopy time, visualization of main structures, and technical success rates were compared between the supine and prone positions. Univariate and multivariate regressions were performed to adjust for age, sex, ethnicity and clinical setting. RESULTS: A total of 21,090 patients who underwent ERCP were included, of whom 1769 (8.4%) were supine and 19,321 (91.6%) were prone. The common bile duct (CBD) was visualized and cannulated in 89.1% of supine vs. 91.4% of prone positions (P=0.017), while the ampulla was visualized in 97.1% of supine vs. 97.7% of prone (P=0.414). The ERCP was incomplete in 10% of supine vs. 5% of prone cases (P<0.001). On multivariate analysis, supine position required shorter procedure times than prone (adjusted odds ratio [aOR] 0.98, 95% confidence interval [CI] 0.98-0.98; P<0.001). The supine position also yielded lower odds of CBD visualization and cannulation (aOR 0.63, 95%CI 0.44-0.91; P=0.011) and higher odds of an incomplete examination (aOR 1.84, 95%CI 1.46-2.30; P<0.001) vs. prone. CONCLUSIONS: The supine position leads to shorter procedures but is more likely to result in poorer visualization and cannulation of the CBD and an incomplete examination. This may reflect the technical difficulty of performing ERCP in the supine position for the endoscopist. Our study supports recommendations for an individualized ERCP approach.

Comparison of idiopathic recurrent acute pancreatitis [IRAP] and recurrent acute pancreatitis with genetic mutations.

BACKGROUND: Idiopathic recurrent acute pancreatitis (IRAP) describes frequent episodes of pancreatitis without an etiology found using current testing. We compared the natural history of IRAP with recurrent acute pancreatitis with genetic mutations. METHODS: Retrospective cohort of patients with recurrent acute pancreatitis (≥2 episodes) and negative conventional testing. All patients had ≥1 episode after cholecystectomy and completed genetic testing. Primary outcomes were chronic pancreatitis incidence, pancreatic cancer, and mortality. Secondary outcomes included opioid and ERCP utilization. RESULTS: 128 patients met criteria for presumed IRAP. 35 patients met criteria for true IRAP. 12 patients had recurrent acute pancreatitis with gene mutations. Chronic pancreatitis developed in 27 (77.1%) IRAP patients over a median of 6 years. Chronic pancreatitis incidence was similar in IRAP and CFTR mutation carriers; but developed later in SPINK1 carriers. No patients developed pancreatic cancer or died from pancreatic-related causes. Patients were frequently treated with oral opioids and ERCP, without significant differences within or between groups. CONCLUSION: IRAP and pancreatitis in mutation carriers is associated with chronic pancreatitis. Important differences in natural history were observed, but no association was found with cancer or pancreas-related mortality. Efforts to understand the genetic contributions to IRAP, minimize opioids and unnecessary ERCPs are encouraged.

Quality and Readability of Web-Based Information for Patients With Pancreatic Cysts: DISCERN and Readability Test Analysis.

BACKGROUND: Pancreatic cysts are a complex medical problem with several treatment options. Patients use web-based health information to understand their conditions and to guide treatment choices. OBJECTIVE: The goal of this study was to describe the quality and readability of publicly available web-based information on pancreatic cysts and to compare this information across website affiliations. METHODS: A Google search for "pancreatic cysts" was performed and the first 30 websites were evaluated. Website affiliations were classified as academic, media, nonprofit, government, or not disclosed. Information describing cancer risk was recorded. The DISCERN instrument measured the quality of content regarding treatment choices. Four standardized tests were used to measure readability. RESULTS: Twenty-one websites were included. The majority of the websites (20/21, 95%) described the cancer risk associated with pancreatic cysts. Nearly half of the websites were written by an academic hospital or organization. The average DISCERN score for all websites was 40.4 (range 26-65.5, maximum 80). Websites received low scores due to lack of references, failure to describe the risks of treatment, or lack of details on how treatment choices affect quality of life. The average readability score was 14.74 (range 5.76-23.85, maximum 19+), indicating a college reading level. There were no significant differences across website affiliation groups. CONCLUSIONS: Web-based information for patients with pancreatic cysts is of moderate quality and is written above the reading level of most Americans. Gastroenterological, cancer treatment organizations, and physicians should advocate for improving the available information by providing cancer risk stratification, treatment impact on quality of life, references, and better readability.

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.

A 3-Decade Analysis of Pancreatic Adenocarcinoma After Solid Organ Transplant.

OBJECTIVE: Solid organ transplant (SOT) recipients have moderately increased risk of pancreatic adenocarcinoma (PAC). We evaluated the incidence and survival of PAC in 2 cohorts and aimed to identify potential risk factors. METHODS: This study performed a retrospective cohort analysis. Cohort A was extracted from the United Network of Organ Sharing data set and cohort B from SOT recipients evaluated at 3 Mayo Clinic transplant centers. The primary outcome was age-adjusted annual incidence of PAC. Descriptive statistics, hazard ratios, and survival rates were compared. RESULTS: Cohort A and cohort B included 617,042 and 29,472 SOT recipients, respectively. In cohort A, the annual incidence rate was 12.78 per 100,000 in kidney-pancreas, 13.34 in liver, and 21.87 in heart-lung transplant recipients. Receiving heart-lung transplant, 50 years or older, and history of cancer (in either recipient or donor) were independent factors associated with PAC. Fifty-two patients developed PAC in cohort B. Despite earlier diagnosis (21.15% with stage I-II), survival rates were similar to those reported for sporadic (non-SOT) patients. CONCLUSIONS: We report demographic and clinical risk factors for PAC after SOT, many of which were present before transplant and are common to sporadic pancreatic cancer. Despite the diagnosis at earlier stages, PAC in SOT portends a very poor survival.

Cost-Effectiveness of an Adjuvanted Hepatitis B Vaccine (HEPLISAV-B) in Patients With Inflammatory Bowel Disease.

Background: Compare the cost-effectiveness of 2 recombinant hepatitis B virus (HBV) vaccines in patients with inflammatory bowel disease (IBD). Methods: Markov models were developed for 2 IBD cohorts: (1) 40-year-old patients prior to starting IBD treatment and (2) 40-year-old patients already receiving therapy. Cohort A received full vaccination series, cohort B had primary vaccine failure and received a vaccine booster. Two vaccines were compared: adjuvanted HEPLISAV-B and nonadjuvanted Engerix-B. Clinical probabilities of acute hepatitis, chronic hepatitis, cirrhosis, fulminant hepatic failure and death, treatment costs, and effectiveness estimates were obtained from published literature. A lifetime analysis and a US payer perspective were used. Probabilistic sensitivity analyses were performed for different hypothetical scenarios. Results: Analysis of cohort A showed moderate cost-effectiveness of HEPLISAV-B ($88,114 per quality-adjusted life year). Analysis of cohort B showed increased cost-effectiveness ($35,563 per quality-adjusted life year). Changing Engerix-B to HEPLISAV-B in a hypothetical group of 100,000 patients prevented 6 and 30 cases of acute hepatitis; and 4 and 5 cases of chronic hepatitis annually for cohorts A and B, respectively. It also prevented 1 and 2 cases of cirrhosis, and 1 and 2 deaths over 20 years for each cohort. Cost-effectiveness was determined by vaccination costs, patient age, and progression rate from chronic hepatitis to cirrhosis. Conclusions: HEPLISAV-B is cost-effective over Engerix-B in patients receiving immunosuppressive therapy for IBD. Benefits increase with population aging and lower costs of vaccines. We advocate measuring levels of HBV antibodies in patients with IBD and favor adjuvanted vaccines when vaccination is needed.

Acute Pancreatitis in Celiac Disease: Has the Inpatient Prevalence Changed and Is It Associated With Worse Outcomes?

OBJECTIVES: Studies suggest that adults diagnosed with celiac disease (CD) are at higher risk of developing acute pancreatitis (AP). The aim of this study is to explore the relationship between CD and AP in terms of inpatient prevalence, mortality, morbidity, and resource utilization in the past decade. METHODS: Retrospective cohort study using the Nationwide Inpatient Sample (2007-2016). The primary outcome was the occurrence of AP in CD patients. Secondary outcomes were the trend in AP cases in CD patients, and mortality, morbidity, length of stay, and total hospital charges and costs. RESULTS: Of 337,201 CD patients identified, 7372 also had AP. The mean age was 53 years, 71% were women. The inpatient prevalence of AP in CD was 2.2% versus 1.2% in non-CD cohort (P < 0.01). Patients with CD displayed increased odds of having AP (adjusted odds ratio, 1.92; P < 0.01). Patients with AP and CD displayed lower odds of morbidity and mortality than non-CD patients with AP. CONCLUSIONS: The inpatient prevalence of AP is higher in CD patients, and increased from 2007 to 2016. Patients with CD and AP displayed lower morbidity and mortality, which may suggest that they have a less severe form of AP or lower baseline comorbidity.

Left Ventricular Assist Device Therapy and Acute Pancreatitis: Higher Incidence and Worse Clinical Outcomes.

OBJECTIVE: The aim of the study was to compare incidence and outcomes of acute pancreatitis among advanced heart failure therapies. METHODS: Two retrospective cohorts are as follows: A, patients with heart failure presenting to our hospitals and B, the US National Inpatient Sample. Three groups were compared: left ventricular assist device (LVAD) recipients, transplant recipients, and controls who did not qualify for advanced therapies. Primary outcomes were pancreatitis incidence and mortality. Secondary outcomes included kidney failure, multiorgan failure, shock, and health care utilization. RESULTS: Cohort A included 1344 heart failure patients, and cohort B included 677,905 patients with acute pancreatitis. In cohort A, annual pancreatitis incidence was 6.7 cases per 1000 LVAD recipients, 4.1 per 1000 LVAD bridge-to-transplant, 2.3 per 1000 transplant recipients, and 3.2 per 1000 heart failure controls (P = 0.03). Combined, the incidence was 5.6 per 1000 LVAD users and 2.7 in 1000 non-LVAD users (relative risk, 2.1; P = 0.009). In cohort B, increased mortality was seen in LVAD users, but not in transplant recipients. Left ventricular assist device patients had higher odds of kidney failure, multiorgan failure, shock, and intensive care. CONCLUSIONS: Patients with LVAD have double risk of pancreatitis, worse clinical outcomes, and increased healthcare utilization. Studies elucidating the mechanisms behind pancreatic injury in advanced heart failure are suggested.