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Background: The American Foregut Society (AFS) is dedicated to advancing patient care and digestive health within the realm of foregut disease. One of the most common and debilitating esophageal conditions is gastroesophageal reflux disease (GERD). The Hill grade is an endoscopic classification of the esophagogastric junction (EGJ) based on the appearance of the gastroesophageal flap valve from a retroflexed view of the hiatus. This endoscopic classification provides insight into the anatomic disruption of the EGJ which has been shown to correlate with GERD. However, clinical utilization of this classification by endoscopists has been limited due to the perceived relevance and subjectivity of the classification. With the advent of endoscopic treatment options for GERD, there is renewed enthusiasm to develop a grading system of the EGJ that can objectively define anatomical impairment and reduce interobserver grading variability. Methods: The AFS convened a 13-member working group tasked with reviewing the Hill grade classification and formulating a proposal for its revision utilizing a modified Delphi method. This white paper summarizes the output from this working group. Results: The working group concluded that all components of the antireflux barrier—the lower esophageal sphincter and its sling fibers, the crural diaphragm, and the gastroesophageal flap valve—contribute to EGJ integrity. Using defined objective parameters of extent of hiatal axial herniation and crural disruption and presence or absence of a flap valve, the new AFS classification stratifies EGJ integrity from normal (grade 1) to increasing degrees of EGJ disruption (grade 2-4) beginning with loss of the flap valve and progressing to increasing degrees of crural disruption and hiatus hernia. This AFS classification also stipulates appropriate endoscopic methodology to utilize in making the assessment and provides a basic nomenclature for communication among endoscopists. Conclusions: The AFS endoscopic classification of the EGJ expands on the Hill classification by including assessment of axial hiatal hernia length (L), hiatal aperture diameter (D), and presence or absence of the flap valve (F) making it more comprehensive - LDF components. Future directions include validation studies correlating the ability of the AFS classification in predicting the presence and severity of GERD.

Background : The spread of duodenoscope-related infections has led to the recognition that reprocessing of duodenoscopes using high-level disinfection (HLD), if done perfectly, narrowly meets the advised thresholds of endoscope decontamination. In 2019, the US Food and Drug Administration (FDA) recommended a transition to duodenoscopes designed to pose less risk, including the use of disposable duodenoscopes. The EXALT Model-D™ single-use duodenoscope (EXALT) has been shown to be substantially equivalent to reusable duodenoscopes for clinical use. The objective of this study was to estimate the cost-effectiveness of EXALT in the United States Healthcare system. Methods : A cost-effectiveness model was developed comparing HLD, culture-and-quarantine (CQ), Ethylene oxide sterilization (ETO), and EXALT in a simulated cohort undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) for choledocholithiasis. Published information was leveraged describing clinical estimates, infectious outbreaks, and hospital costs. Results : In a base analysis, HLD was the least costly ($962), and EXALT was the costliest ($3,000), but yielded the most QALYs (0.0172 incremental QALYs). The incremental cost-effectiveness ratio was $38,461 for ETO gas sterilization and $62,185 for EXALT. However, with the availability of device-specific reimbursement for EXALT in the US in the form of transitional pass-through payment (TPT) and new technology add-on payment (NTAP), EXALT provided the highest cost-savings to the hospital versus alternative strategies by maintaining QALY gains while decreasing estimated net costs. Probabilistic sensitivity analyses showed EXALT to be preferred compared to HLD over a range of willingness-to-pay. Conclusion : EXALT is a viable and cost-effective strategy that should be strongly considered for ERCP.

Poultry coccidiosis is an important devitalizing enteric protozoan disease caused by a group of obligatory intracellular apicomplexan parasites of the Genus Eimeria contributing to major economic loss in commercial poultry worldwide. As the current method of chemotherapeutic control using Ionophores in feed had led to development of drug resistant isolates, the need for development of prophylactic vaccines is the most viable alternate and eco-friendly control strategy as on date. Of the several candidate vaccines, the EmGam 56 is one of the most promising candidates which protect the birds against E.maxima, E.tenella and E.acervulina, the three most pathogenic coccidian species infecting commercial chicken.EmGam56 is a major wall forming component of macrogametocyte of E.maxima and a candidate with high immunogenicity and low virulence. Based on the above, the present study was planned and carried out for the generation of E.coli expressed recombinant gametocyte antigen-EmGam56 using pET 28(a+) as cloning vector and BL21 DE3 (pLysS) as expression vector in a Bio-fermentor (New Brunswick™ Scientific BioFlo 310). The recombinant protein was purified by conventional (Ammonium sulfate) and by automatic purification system (AKTA prime) in Ni-NTA column for a planned immunization trial with experimental chickens.

DESCRIPTION: The purpose of this best practice advice (BPA) article from the Clinical Practice Update Committee of the American Gastroenterological Association is to provide an update on advances and innovation regarding the screening and surveillance of Barrett’s esophagus. METHODS: The BPA statements presented here were developed from expert review of existing literature combined with discussion and expert opinion to provide practical advice. Formal rating of the quality of evidence or strength of BPAs was not the intent of this clinical practice update. This expert review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the CPUC and external peer review through standard procedures of Clinical Gastroenterology and Hepatology. BEST PRACTICE ADVICE 1: Screening with standard upper endoscopy may be considered in individuals with at least 3 established risk factors for Barrett’s esophagus (BE) and esophageal adenocarcinoma, including individuals who are male, non-Hispanic white, age >50 years, have a history of smoking, chronic gastroesophageal reflux disease, obesity, or a family history of BE or esophageal adenocarcinoma. BEST PRACTICE ADVICE 2: Nonendoscopic cell-collection devices may be considered as an option to screen for BE. BEST PRACTICE ADVICE 3: Screening and surveillance endoscopic examination should be performed using high-definition white light endoscopy and virtual chromoendoscopy, with endoscopists spending adequate time inspecting the Barrett’s segment. BEST PRACTICE ADVICE 4: Screening and surveillance exams should define the extent of BE using a standardized grading system documenting the circumferential and maximal extent of the columnar lined esophagus (Prague classification) with a clear description of landmarks and the location and characteristics of visible lesions (nodularity, ulceration), when present. BEST PRACTICE ADVICE 5: Advanced imaging technologies such as endomicroscopy may be used as adjunctive techniques to identify dysplasia. BEST PRACTICE ADVICE 6: Sampling during screening and surveillance exams should be performed using the Seattle biopsy protocol (4-quadrant biopsies every 1–2 cm and target biopsies from any visible lesion). BEST PRACTICE ADVICE 7: Wide-area transepithelial sampling may be used as an adjunctive technique to sample the suspected or established Barrett’s segment (in addition to the Seattle biopsy protocol). BEST PRACTICE ADVICE 8: Patients with erosive esophagitis should be biopsied when concern of dysplasia or malignancy exists. A repeat endoscopy should be performed after 8 weeks of twice a day proton pump inhibitor therapy. BEST PRACTICE ADVICE 9: Tissue systems pathology-based prediction assay may be utilized for risk stratification of patients with nondysplastic BE. BEST PRACTICE ADVICE 10: Risk stratification models may be utilized to selectively identify individuals at risk for Barrett’s associated neoplasia. BEST PRACTICE ADVICE 11: Given the significant interobserver variability among pathologists, the diagnosis of BE-related neoplasia should be confirmed by an expert pathology review. BEST PRACTICE ADVICE 12: Patients with BE-related neoplasia should be referred to endoscopists with expertise in advanced imaging, resection, and ablation. BEST PRACTICE ADVICE 13: All patients with BE should be placed on at least daily proton pump inhibitor therapy. BEST PRACTICE ADVICE 14: Patients with nondysplastic BE should undergo surveillance endoscopy in 3 to 5 years. BEST PRACTICE ADVICE 15: In patients undergoing surveillance after endoscopic eradication therapy, random biopsies should be taken of the esophagogastric junction, gastric cardia, and the distal 2 cm of the neosquamous epithelium as well as from all visible lesions, independent of the length of the original BE segment.

Objective Bile duct dilation (BDD) of unclear etiology is a common indication for further imaging via endoscopic ultrasound (EUS). We aimed to assess the yield of EUS in determining BDD etiology in patients with prior non-diagnostic imaging studies. Methods A retrospective chart review was performed at a single, tertiary-care university hospital for patients referred for EUS for BDD with or without pancreatic duct dilation (PDD). EUS-guided fine needle aspiration (FNA) was performed if a focal lesion was identified. Cases with an etiology of BDD diagnosed or strongly suggested by prior imaging were excluded. EUS findings believed to represent a structural cause for BDD included a wide range of pancreaticobiliary and luminal pathology as well as patients' clinical factors. Results In total, 307 patients were identified. Findings to explain BDD were found by EUS in 213 patients for a diagnostic yield of 69.4%. Patients with jaundice were significantly more likely to receive a diagnosis by EUS than those without (78.8% vs 55.3%, P Conclusions EUS continues to play a substantial role in evaluating BDD of unclear etiology, most notably in patients with jaundice. In addition, given that 8.1% of asymptomatic patients without jaundice or abnormal LFT had malignancy diagnosed on EUS, the use of EUS for BDD of unclear etiology remains warranted. Take home messages The diagnostic yield of EUS in patients referred for bile duct dilation of unclear etiology was substantial at 69.4%. Nearly 1/5 (19.5%) of patients referred for evaluation of a dilated bile duct failed to have confirmation of bile duct dilation on EUS. Even among patients with normal LFT, a malignancy was found by EUS in 8.1% of patients. Because important pathology, including malignancy, was frequently discovered by EUS in patients with seemingly incidental bile duct dilation, the routine use of EUS and EUS-FNA/FNB for this indication seems warranted.

Background and study aims Recent outbreaks attributed to contaminated duodenoscopes have led to the development of enhanced surveillance and reprocessing techniques (enhanced-SRT) aimed at minimizing cross-contamination. Common enhanced-SRT include double high-level disinfection (HLD), ethylene oxide (EtO) gas sterilization, and culture-based monitoring of reprocessed scopes. Adoption of these methods adds to the operational costs and we aimed to assess its economic impact to an institution. Methods We compared the estimated costs of three enhanced-SRT versus single-HLD using data from two institutions. We examined the cost of capital measured as scope inventory and frequency of scope use per unit time, the constituent reprocessing costs required on a per-cycle basis, and labor & staffing needs. The economic impact attributable to enhanced-SRT was defined as the difference between the total cost of enhanced-SRT and single HLD. Results Compared to single HLD, adoption of double HLD increased the costs approximately by 47 % ($80 vs $118). Similarly, culture and quarantine and EtO sterilization increased costs by 160 % and 270 %, respectively ($80 vs $208 and $296). Enhanced-SRT introduced significant scope downtime due to prolonged techniques, necessitating a 3.4-fold increase in the number of scopes needed to maintain procedural volume. The additional annual budget required to implement enhanced-SRT approached $406,000 per year in high-volume centers. Conclusions While enhanced-SRT may reduce patient risk of exposure to contaminated duodenoscopes, it significantly increases the cost of performing ERCP. Future innovation should focus on approaches that can ensure patient safety while maintaining the ability to perform ERCP in a cost-effective manner.

Background and Aims: Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience. Methods: Fourteen “expert” (>2000 lifetime ERCPs) and 5 “less-expert” endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events. Results: Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P =.131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P =.999), median ERCP completion time (25.0 vs 28.5 minutes, P =.130), mean cannulation attempts (2.8 vs 2.8, P =.954), and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0 [range, 1.0-10.0], P =.840) were similar for expert versus less-expert endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grades 1 to 2 versus grades 3 to 4 (P Conclusions: In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinical trial registration number: NCT04223830.)

Endoscopic screening for Barrett’s esophagus (BE) is common, costly, and underperformed in at-risk people. A non-endoscopic cell collection device can be used to collect esophageal cells, enabling BE screening. This study assessed the acceptability and adequacy of a commercial non-endoscopic cell collection device in a US population. Six sites enrolled patients with confirmed BE or heartburn/regurgitation for ≥ 6 months. Patients underwent administration of the device, consisting of a sponge encapsulated in a capsule. The capsule dwelled in the stomach for 7.5 min and was retracted via an attached suture. An adequate sample was ≥ 1 columnar cell by H&E staining. Sample quality was rated using a 0–5 scale, with 0 = no columnar cells and 5 = plentiful groups. Trefoil Factor 3 (TFF3) staining was performed. Accuracy was assessed using esophagogastroduodenoscopy (EGD)/biopsy as the gold standard. Of 191 patients, 99.5% successfully swallowed the device. Overall sample adequacy was 91% (171/188), with 84% (158/188) high quality. The detachment rate was 2/190 (1%). Overall sensitivity, specificity, and accuracy of the assay with TFF3 staining were 76%, 77%, and 76%. Sensitivity, specificity, and accuracy for ≥ 3 cm BE were 86%, 77%, and 82%. Asked if willing to repeat the procedure, 93% would, and 65% indicated a preference for the device over EGD. This study demonstrated a high rate of sample adequacy and promising acceptability of this non-endoscopic sampling device in a US population. Diagnostic characteristics suggest that non-endoscopic assessment of BE deserves further development as an alternative to endoscopy.

Background & Aims Endoscopic ultrasound-guided placement of LAMS has emerged as an effective treatment for WON following acute necrotizing pancreatitis, but a standardized management protocol has not yet emerged. We sought to characterize practice variations in the use of lumen-apposing metal stents (LAMS) for the treatment of walled-off pancreatic necrosis (WON). Methods A 30-question survey was sent to 341 endoscopists in the United States to collect information on practitioner demographics, procedural practices, necrosectomy practices, and LAMS-related adverse events. Results A total of 69 of the 341 surveys were completed for a response rate of 20.2%. Almost all reported using LAMS placement as the primary method of WON treatment (92.5%). At the time of LAMS placement, almost half of respondents perform balloon dilation (45.2%), and a minority place pigtail stents through the LAMS channel (15.0%). Necrosectomy is performed by less than half during index LAMS placement procedure (46.8%). Approximately half never use hydrogen peroxide lavage (52.4%). Most respondents reported experiencing adverse events at some point. About half reported a stent indwell time of the greater than 1 month. Conclusion A convergence of practice patterns when using LAMS to treat WON has not been demonstrated. Considerable variability exists in certain aspects of LAMS use including placement technique, necrosectomy practices, follow-up treatment, and stent removal. Further investigation is necessary to standardize this procedure to effectively and safely treat WON.

The evolution of endoscopic ultrasound (EUS) from a diagnostic to a therapeutic procedure has resulted in a paradigm shift toward endoscopic management of disease states that previously required percutaneous or surgical approaches. The past few years have seen additional techniques and devices that have enabled endoscopists to expand its diagnostic and therapeutic capabilities. Some of these techniques initially were reported more than a decade ago; however, with further device development and refinement in techniques there is potential for expanding the application of these techniques and new technologies to a broader group of interventional gastroenterologists. Lack of formalized training, devices, and prospective data regarding their use in addition to a scarcity of guidelines on implementation of these technologies into clinical practice are contributing factors impeding the growth of the field of interventional EUS. In April 2019, the American Gastroenterological Association's Center for Gastrointestinal Innovation and Technology conducted its annual Tech Summit and a key session focused on interventional EUS. This article is a White Paper generated from the conference, discusses the published literature pertaining to the topic of interventional EUS, and outlines a proposed framework for the implementation of interventional EUS techniques into clinical practice. Three primary areas of interventional EUS are addressed: (1) EUS-guided access; (2) EUS-guided tumor ablation; and (3) endohepatology. There was general agreement among participants on several key components. The introduction of these novel interventions requires better tools, more data on safety/outcomes, and improved training for endoscopists. Participants also agreed that widespread implementation and use of these techniques will require support from Gastrointestinal Societies and other key stakeholders including payers. Continued work by the Gastrointestinal Societies and manufacturers to provide training programs, appropriate equipment/work environments, and policies that motivate endoscopists to adopt new techniques is essential for growing the field of interventional EUS.