Assessment of the Learning Curve for a Single-Use Disposable Duodenoscope.

BACKGROUND AND AIMS: In response to documented duodenoscope-related infectious outbreaks of multidrug-resistant organisms, the Food and Drug Administration has recommended a transition to duodenoscopes with innovative designs, including duodenoscopes with disposable components or fully disposable duodenoscopes. We aim to characterize the learning curve (LC) for a single-use disposable duodenoscope. METHODS: We performed a retrospective analysis of a prospectively collected database from 31 patients who underwent ERCP by a single, experienced operator using the EXALT Model D® (Boston Scientific, Marlborough) disposable duodenoscope at a single tertiary referral center. The LC for this device was described by the number of cases needed to achieve proficiency using cumulative sum (CUSUM) analysis. Number of attempts to cannulate and time to cannulate the desired duct were assessed as separate endpoints. The overall mean number of attempts and overall mean time to cannulation were used as the target values in the respective CUSUM analyses. Proficiency was defined as the number of procedures where an inflection point was reached in the CUSUM graph. This observation indicates improving operator performance as shown by a decrease in the number of attempts and shortening of cannulation time after the defined number of procedures. RESULTS: Overall, 31 patients underwent ERCP using the EXALT Model D disposable duodenoscope by a single experienced endoscopist. 6 (19%) patients had a native papilla and the majority of these procedures were classified as ASGE complexity level 2 or above. The procedure was completed using solely the disposable duodenoscope in 27 patients (87%), while a reusable duodenoscope was required for procedure completion in 4 patients (13%). The cross-overs were distributed evenly across the performance period. Procedure-related adverse events included: post-ERCP pancreatitis (3%), bleeding (3%) and no perforations. In the analyses of both endpoints, an inflection of the CUSUM curves is achieved at 10 cases, indicating sustained reduction of cannulation attempts and time to cannulation. CONCLUSION: Among experienced pancreaticobiliary endoscopists, approximately 10 ERCPs is the threshold whereby procedure-related factors including cannulation success and procedural time improves. Procedure-related adverse events are consistent with those expected with reusable duodenoscopes. The need to cross-over from single-use duodenoscope to reusable duodenoscope did not appear to be related to the learning curve, as they were evenly distributed across the study period. These results can be used to guide adoption of single-use duodenoscopes into clinical practice.

Factors predictive of hospital length of stay in patients with an index episode of acute necrotizing pancreatitis.

INTRODUCTION: Acute necrotizing pancreatitis (ANP) complicates 15 % of acute pancreatitis cases and is associated with prolonged length of stay (LOS). There are limited studies exploring potential predictors. METHODS: We carried out a retrospective study of all consecutive patients presenting to a large referral healthcare system with ANP. Patients younger than 18 years of age, without confirmed glandular necrosis and with in-hospital mortality were excluded. Poisson regression was carried out to identify potential predictors of prolonged hospital stay. RESULTS: One hundred and sixty-two patients hospitalized between December 2016 and June 2020 were included. The median LOS was 12 days (range: 1-155 days). On multivariate analysis, organ dysfunction at presentation (Incidence rate ratio (IRR) 1.21, p = 0.01) or during admission (IRR 1.32, p = 0.001), Charlson Comorbidity Index scores (IRR 1.1 per CCI point, p < 0.001), known chronic pancreatitis (IRR 1.19, p = 0.03), concurrent (non-pancreas related) infections (IRR 1.13, p = 0.04), need for enteral tube placement (IRR 3.42, p < 0.001) and in-hospital interventions (IRR 1.48-2.85 depending on intervention, p < 0.001) were associated with increased LOS. For patients in the cohort to whom this applied, delayed hospital transfers (IRR 1.02, p < 0.001) and delayed start of enteral feeds (IRR 1.01, p = 0.017) contributed to increased overall LOS. CONCLUSION: We demonstrate that multiple factors including delayed transfers to hospitals with pancreaticobiliary expertise lead to increased length of hospitalization. We suggest various strategies that can be considered to target those gaps and may have a favorable effect on LOS.

Timing of ERCP after extracorporeal shock wave lithotripsy for large main pancreatic duct stones.

BACKGROUND AND AIMS: Extracorporeal shock wave lithotripsy (ESWL) is performed to fragment large main pancreatic duct (MPD) stones in symptomatic patients. Subsequent endoscopic retrograde cholangiopancreatography (ERCP) is often performed to clear the stone fragments. Edema of surrounding tissue after ESWL theoretically affects the ability to perform ERCP. However, the optimal timing of ERCP after ESWL is not clearly defined. The aim of this study is to determine the efficacy and safety of same-day ERCP after ESWL and to determine if the timing of ERCP after ESWL affects outcomes. METHODS: This is a retrospective study of consecutive patients from January, 2013 to September, 2019 who received ESWL for MPD stones at our center. Included patients received subsequent same-day ERCP under the same general anesthesia session or later session ERCP (1-30 days after ESWL). Demographics, anatomical findings, history, and outcomes were collected. Success was defined as complete or near complete (> 80%) stone fragmentation with clearance. RESULTS: 218 patients were treated with ESWL and subsequent ERCP. 133 (61.0%) received ERCP on the same day immediately after ESWL, while 85 (39.0%) returned for ERCP at a later day (median 3.0 days after ESWL). Baseline characteristics demonstrated patients who received same-day ERCP had a higher rate of pain at baseline (94.7% vs 87.1%, p = 0.045). Main outcomes demonstrated an overall successful MPD stone clearance rate of 90.4%, with similar rates between same-day ERCP and later session ERCP (91.7% vs 88.2%, p = 0.394). Additionally, successful cannulation at ERCP, adverse events, and post-procedure admission rates were similar. CONCLUSIONS: Delaying ERCP to allow peripancreatic tissue recovery after ESWL does not affect outcomes. Same-day ERCP after ESWL is safe and effective.

Causal speech enhancement using dynamical-weighted loss and attention encoder-decoder recurrent neural network.

Speech enhancement (SE) reduces background noise signals in target speech and is applied at the front end in various real-world applications, including robust ASRs and real-time processing in mobile phone communications. SE systems are commonly integrated into mobile phones to increase quality and intelligibility. As a result, a low-latency system is required to operate in real-world applications. On the other hand, these systems need efficient optimization. This research focuses on the single-microphone SE operating in real-time systems with better optimization. We propose a causal data-driven model that uses attention encoder-decoder long short-term memory (LSTM) to estimate the time-frequency mask from a noisy speech in order to make a clean speech for real-time applications that need low-latency causal processing. The encoder-decoder LSTM and a causal attention mechanism are used in the proposed model. Furthermore, a dynamical-weighted (DW) loss function is proposed to improve model learning by varying the weight loss values. Experiments demonstrated that the proposed model consistently improves voice quality, intelligibility, and noise suppression. In the causal processing mode, the LSTM-based estimated suppression time-frequency mask outperforms the baseline model for unseen noise types. The proposed SE improved the STOI by 2.64% (baseline LSTM-IRM), 6.6% (LSTM-KF), 4.18% (DeepXi-KF), and 3.58% (DeepResGRU-KF). In addition, we examine word error rates (WERs) using Google's Automatic Speech Recognition (ASR). The ASR results show that error rates decreased from 46.33% (noisy signals) to 13.11% (proposed) 15.73% (LSTM), and 14.97% (LSTM-KF).

COVID-Associated Cast-Forming Cholangiopathy: A Commentary on Disease Mechanism, Treatment, and Prognosis.

The complete impact of COVID-19 infection continues to develop since the onset of the COVID-19 pandemic. COVID-19 cholangiopathy has been recently described in a subset of patients who recovered from severe COVID-19 infection. The most common phenotype of patients suffering from COVID-19 cholangiopathy had severe infection requiring a stay in the intensive care unit, mechanical ventilation and vasopressor medications. Patients with COVID-cholangiopathy present with severe and prolonged cholestatic liver injury. In cases where biliary cast formation is identified, we defined the entity as "COVID-19 cast-forming cholangiopathy". This subset of COVID-19 cholangiopathy is not well understood and there are no standardized diagnosis or management to this date. The reported clinical outcomes are variable, from resolution of symptoms and liver test abnormalities to liver transplant and death. In this commentary, we discuss the proposed pathophysiology, diagnosis, management, and prognosis of this disease.

Developing growth reference charts for the head circumference of Pakistani children aged 6 to 18 years.

BACKGROUND: Head circumference (HC) measurement is a significant measure of brain volume. It is also considered a powerful predictor in the evaluation of developmental and neurological disorders in children. This study aims to develop smoothed reference curves for HC of the Pakistani children of age 6 to 18 years. METHODS: A cross-sectional dataset, consisting of 9194 school-going children of age 6-18 years, were obtained using a multi-ethnic anthropometric survey. For the measurement of HC (cm), the standard procedure was adopted. For both sexes, the smoothed centile curves of HC were developed by using the lambda-mu-sigma (LMS) statistical approach. Moreover, we compared our 50th percentile curves to those produced for few other countries. RESULTS: The centiles curves of both sexes indicated that the HC increased with age. Until the age of 10 years, the boys had larger HC percentiles than those of the girls. From the age of 11 years, upper percentiles (90th, 95th and 97th) of the girls were higher than those of the boys. The comparison of our 50th percentile data for the HC with the data from the United States (US) and Turkish children revealed that the Pakistani children of both genders had smaller head sizes in all ages when compared to those reported for the latter stated countries. CONCLUSIONS: Our results show the larger disparity of HC percentiles in different countries. This comprehensive study suggests that the references from the US Centers for Disease Control and Prevention data and other populations are not suitable for Pakistani children. Therefore, each country is required to create its own HC reference curves, separately.

Efficacy of empiric esophageal dilation in patients with non-obstructive dysphagia: systematic review and meta-analysis.

BACKGROUND AND AIMS: Empiric esophageal dilation is frequently performed for non-obstructive dysphagia. Studies evaluating its efficacy have reported conflicting results. In this meta-analysis, we have evaluated the efficacy of esophageal dilation in the management of non-obstructive dysphagia. METHODS: We reviewed several databases from inception to 26 May 2021 to identify randomized controlled trials (RCTs) and observational studies that evaluated the role of empiric esophageal dilation for non-obstructive dysphagia. Our outcomes of interest were clinical success (improvement in dysphagia after dilation) and difference in post-operative dysphagia score between groups. For categorical variables, we calculated pooled odds ratios (OR) with 95% confidence intervals (CI); for continuous variables, we calculated standardized mean difference (SMD) with 95% CI. Data were analyzed using a random effects model. We used GRADE framework to ascertain the quality of evidence. RESULTS: We included 4 studies (3 RCTs and one observational) with 243 patients; there were 133 treated with empiric dilation and 110 controls. We found no significant difference in clinical success (OR (95% CI) 1.91 (0.89, 4.08)) or post-procedure dysphagia score between groups (SMD (95% CI) 0.38 (-0.37, 1.14)). Our findings remained consistent on subgroup analysis including RCTs only. Quality of evidence ranged from low to very low based on GRADE framework. CONCLUSIONS: Our meta-analysis does not support the use of empiric esophageal dilation in patients with non-obstructive dysphagia. More studies are required to confirm these findings.

A Patient with Eosinophilic Esophagitis and Herpes Simplex Esophagitis: A Case Report and Literature Review.

Acute herpes simplex esophagitis (HSE) is common in immunocompromised patients. Eosinophilic esophagitis (EoE) is characterized by immune-mediated eosinophil-predominant esophageal inflammation. We report a patient with human immunodeficiency virus infection who presented with dysphagia and odynophagia and was found to have HSE and EoE. The combination of these two relatively rare conditions suggests possible predisposition.

Endoscopic transmission of carbapenem-resistant Enterobacteriaceae: implications for U.S. Food and Drug Administration approval and postmarket surveillance of endoscopic devices.

Since the first widely reported case cluster of duodenoscope-associated transmission of carbapenem-resistant Enterobacteriaceae (CRE) in 2013 that affected 38 patients, similar outbreaks have occurred throughout the world. The U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention, professional gastroenterology societies, and endoscope manufacturers have taken multiple steps to address this issue. Unlike prior outbreaks attributed to lapses in cleaning and reprocessing, transmission and outbreaks have continued to occur despite compliance with current reprocessing guidelines. A definitive method of duodenoscope reprocessing remains elusive, and the FDA recently recommended transition to new designs with disposable components that do not require reprocessing. The first fully disposable duodenoscope received FDA clearance as a "breakthrough" device in December 2019. Although the human, microbiologic, and endoscopic design factors responsible for infectious transmissions and disinfecting techniques to avoid them have been examined, discussion has not included the critical role of FDA regulation of duodenoscopes through the 510(k) clearance pathway and the mechanisms of postmarket surveillance, including adverse event reporting. We present an overview of the FDA approval of duodenoscopes by analyzing the FDA's 510(k) premarket notification database for data supporting clearance of duodenoscope models implicated in CRE-related outbreaks as well as subsequently required postmarket studies. We address the policy implications of CRE outbreaks on postmarketing surveillance and the need for increased gastroenterologist involvement in the life cycle of duodenoscopes and other medical devices. This includes reporting thorough adverse event data to the FDA and device manufacturers, supporting active surveillance studies to ensure safety and effectiveness, and evaluating implementation of recommendations to reduce adverse events.

Impact of Moderate versus Deep Sedation and Trainee Participation on Adenoma Detection Rate-Analysis of a Veteran Population.

BACKGROUND/AIMS: The adenoma detection rate (ADR) is used as a quality indicator for screening and surveillance colonoscopy. The study aimed to determine if moderate versus deep sedation affects the outcomes of the ADR and other quality metrics in the veteran population. METHODS: A retrospective review of colonoscopies performed at Memphis Veterans Affairs Medical Center over a one-year period was conducted. A total of 900 colonoscopy reports were reviewed. After exclusion criteria, a total of 229 index, average-risk screening colonoscopies were identified. Data were collected to determine the impact of moderate (benzodiazepine plus opioids) versus deep (propofol) sedation on the ADR, polyp detection rate (PDR), and withdrawal time. RESULTS: Among 229 screening colonoscopies, 103 (44.9%) used moderate sedation while 126 (55%) were done under deep sedation. The ADR and PDR were not significantly different between moderate versus deep sedation at 35.9% vs. 37.3% (p=0.82) and 58.2% vs. 48.4% (p=0.13), respectively. Similarly, there was no significant difference in withdrawal time between moderate and deep sedation (13.4 min vs. 14 min, p=0.56) during screening colonoscopies. CONCLUSION: In veterans undergoing index, average-risk screening colonoscopies, the quality metrics of the ADR, PDR, and withdrawal time are not influenced by deep sedation compared with moderate sedation.

Update on the Management of Helicobacter pylori Infection.

PURPOSE OF REVIEW: Our purpose was to provide an update on methods and indications for testing and treatment selection focusing on novel modalities. RECENT FINDINGS: Increasing antibiotic resistance has reduced treatment effectiveness. Antibiotic resistance testing is not widely available in North America where there are insufficient resistance and susceptibility data. Quadruple regimens (bismuth-based or concomitant/non-bismuth-based) have been recommended first-line. A rifabutin-based combination product recently approved by the US Food and Drug Administration is highly effective and should simplify treatment. The potassium-competitive acid blocker vonoprazan is being evaluated as part of dual or triple combination regimens. Molecular-based genotypic testing for antibiotic resistance and an effective H. pylori vaccine remain under development. SUMMARY: Inability to test for antibiotic resistance renders treatment selection empiric. However, resistance to rifabutin and amoxicillin remains rare. Effective management continues to comprise appropriate diagnostic testing for active infection, utilization of an effective regimen, and post-treatment testing.

Colonic diaphragm disease secondary to nonsteroidal anti-inflammatory drug use.

Diaphragm disease is a rare condition associated with the long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) and can lead to severe complications. Most strictures occur in the small bowel, and occurrence in the colon is rare. We report a case of an asymptomatic patient with colonic diaphragm disease secondary to NSAID use.

Mirtazapine for Refractory Gastroparesis.

Gastroparesis is a chronic condition of delayed gastric emptying in the absence of mechanical outlet obstruction. We report a 47-year-old African American woman with diabetic gastroparesis who presented with intractable nausea, vomiting, and decreased oral intake with electrolyte disturbances. The patient's symptoms were difficult to control with antiemetic and conventional prokinetic agents, and she was started on mirtazapine 15 mg nightly. She experienced an almost complete symptom relief and was able to tolerate solid food within 24-48 hours. We highlight the role of mirtazapine, a 5-HT1a agonist, as an effective therapy for refractory gastroparesis.

Use and abuse of fecal occult blood tests: a community hospital experience.

BACKGROUND: The Fecal Occult Blood Test (FOBT) is one of the diagnostic modalities indicated for screening patients for Colorectal Cancer (CRC). Despite being approved only for screening for CRC, numerous studies in the past have illustrated misuse of the FOBT. We examined utilization of the FOBT for patients admitted to a community teaching hospital. METHODS: The study was conducted at Saint Joseph Hospital, Chicago USA. A retrospective review of Electronic Medical Records (EMRs) of patients admitted from January 2016 to December 2017 was performed. RESULTS: We reviewed the EMRs of 729 patients who received the stool testing for occult blood (FOBT). All tests (100%) were carried out for purposes other than CRC screening. Anemia (38%) was the most common reason documented for carrying out the FOBT. Further, 88% of the tests were ordered on patients who either did not fulfill CRC screening criteria or had other contraindications for testing. Usage of contraindicated medication was the most important factor (58% of patients) that made the candidates ineligible for testing. A total 73 Colonoscopies were ordered for patients who received the test inappropriately with a resulting low yield (0.47%) of CRC diagnosis. CONCLUSION: The stool occult blood test continues to be utilized for reasons other than CRC screening. Majority of patients who underwent the test were not suitable candidates due to the presence of contraindications for testing. Unsuitable FOBT testing led to further unnecessary investigations.

Utilization of Census Tract-Based Neighborhood Poverty Rates to Predict Non-adherence to Screening Colonoscopy.

OBJECTIVES: Efforts to improve colorectal cancer (CRC) screening rates include recognizing predictors of colonoscopy non-adherence and identifying these high-risk patient populations. Past studies have focused on individual-level factors but few have evaluated the influence of neighborhood-level predictors. We sought to assess the effect of census tract-based neighborhood poverty rates on scheduled screening colonoscopy non-adherence. METHODS: In this prospective observational cohort study, data from electronic medical records and appointment tracking software were collected in 599 patients scheduled to undergo outpatient CRC screening colonoscopy at two academic endoscopy centers between January 2011 and December 2012. Non-adherence was defined as failure to attend a colonoscopy appointment within 1 year of the date it was electronically scheduled. Neighborhood poverty rate was determined by matching patients' self-reported home address with their corresponding US census tract. Individual factors including medical comorbidities and prior appointment adherence behavior were also collected. RESULTS: Overall, 17% (65/383) of patients were non-adherent to scheduled colonoscopy at 1-year follow-up. Neighborhood poverty rate was a significant predictor of non-adherence to scheduled screening colonoscopy in multivariate modeling (OR 1.53 per 10% increase in neighborhood poverty rate, 95% CI 1.21-1.95, p < 0.001). By incorporating the neighborhood poverty rate, screening colonoscopy non-adherence was 31% at the highest quartile compared to 14% at the lowest quartile of neighborhood poverty rates (p = 0.006). CONCLUSIONS: Census tract-based neighborhood poverty rates can be used to predict non-adherence to scheduled screening colonoscopy. Targeted efforts to increase CRC screening efficiency and completion among patients living in high-poverty geographic regions could reduce screening disparities and improve utilization of endoscopy unit resources.

Spontaneous bacterial empyema: an elusive diagnosis in a patient with cirrhosis.

Hepatic hydrothorax refers to the presence of a pleural effusion (usually >500 mL) in a patient with cirrhosis in whom other causes of pleural effusion, such as cardiopulmonary causes, pleural disease or malignancy have been excluded. It is seen in 5%-10% of patients with end-stage liver disease. A subset of these patients can develop infection of the hepatic hydrothorax, called spontaneous bacterial empyema. They may present with fever, chills and dyspnoea. We present the case of an 83-year-old man with a history of cirrhosis who developed a large right-sided pleural effusion, confirmed to be empyema by pleural fluid analysis. We aim to highlight the occurrence of spontaneous bacterial empyema. While less common that spontaneous bacterial peritonitis as a complication of cirrhosis, it is equally serious with potential for adverse outcomes.