Search

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.

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.

Background and Aims Single-use/disposable duodenoscopes represent one strategy to decrease the risk of patient infection related to ERCP. A preliminary case series was performed to demonstrate the feasibility and performance of a new single-use duodenoscope in a real-world clinical setting. Methods A single expert endoscopist performed ERCP for standard indications using a single-use duodenoscope. Results Videos of several key steps of ERCP obtained from 4 patients are shown to demonstrate that these steps can successfully be performed using the new single-use device. Clip 1 shows a patient with a large pancreatic duct stone in whom the image quality and maneuverability are demonstrated. Clip 2 shows a patient with choledocholithiasis and demonstrates bile duct cannulation, cholangiography, and sphincterotomy. Clip 3 shows a patient with acute cholecystitis and choledocholithiasis who underwent bile duct cannulation, sphincterotomy, and balloon sweeps. Clip 4 shows a patient with a history of liver transplant and refractory biliary anastomotic stricture who presented with abnormal liver tests and fever and underwent removal of a metal stent and placement of plastic stents. Conclusions A single-use duodenoscope can successfully accomplish fundamental steps of ERCP. This device can potentially eliminate the risk of patient-to-patient infections linked to contaminated instruments. Larger studies are required to assess device performance.

While traditionally employed to manage malignant gastrointestinal (GI) obstruction, a variety of luminal stents have been employed in the management of refractory benign GI strictures with varying safety and efficacy profiles. These include: self-expanding metal stents (SEMS), self-expanding plastic stents (SEPS), biodegradable stents and lumen-apposing metal stents (LAMS). LAMS have become instrumental as an alternate strategy to treat benign gastric outlet obstruction in the setting of native and postsurgical anatomy. This includes transpyloric placement as well as EUS-guided gastrojejunostomy creation as an alternative to laparoscopic gastrojejunostomy and endoluminal stenting. The novel application of LAMS for complete endoscopic management with anastomotic decompression of afferent loop syndrome has also been met with success in case reports and series. This approach with LAMS obviates the need for external drains and complex repeat surgeries. Finally, SEMS have been used to address benign and malignant strictures of the small bowel. However, SEMS use for this indication has been hindered by limitations in endoscopic accessibility of target sites and the current state of stent delivery systems. Whereas the role of colonic stenting for malignant colonic obstruction is well-established, the use of stents to treat benign colonic strictures continues to evolve. While the existing armamentarium of GI luminal stents has revolutionized the management of a variety of clinical conditions, additional advances could further broaden the potential applications of these devices.

Backgrounds & Aims Endoscopic management of gastroesophageal reflux disease (GERD) is being employed increasingly. The aim of this scoping review was to assess the volume of available evidence on the benefits of endoscopic and minimally invasive surgical therapies for GERD. METHODS criteria were used to perform an extensive literature search of data regarding the reported benefit of endoscopic therapies in GERD. Randomized controlled studies were utilized when available; however, data from observational studies were also reviewed. Results A formal review of evidence was performed in 22 studies. Inclusion and exclusion criteria and study duration were noted and tabulated. Assessment of outcomes was based on symptoms and objective criteria reported by investigators. Reported outcomes for the interventions were tabulated under the heading of subjective (symptom scores, quality of life metrics, and change in proton pump inhibitor use) and objective metrics (pH parameters, endoscopic signs, and lower esophageal sphincter pressure changes). Adverse events were noted and tabulated. The majority of studies showed symptomatic and objective improvement of GERD with the device therapies. Adverse events were minimal. However, normalization of acid exposure occurred in about 50% of patients and, for some modalities, long-term durability is uncertain. Conclusions This scoping review revealed that the endoluminal and minimally invasive surgical devices for GERD therapy are a promising alternative to proton pump inhibitor therapy. Their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially durability of effect, are better understood.

Background In stable patients, video capsule endoscopy (VCE) is the recommended first test for patients presenting with suspected small bowel bleeding (SSB). The aim of this study is to develop a scoring system to aid clinicians in deciding which patients with SSB would benefit from VCE. A multicenter database of patients who underwent VCE for SSB was created. Methods A multivariable logistic regression analysis was utilized on a developmental cohort to determine independent predictors of a positive diagnosis on VCE and develop the scoring system. Receiver operating characteristic analysis compared the performance of the scoring system between the developmental cohort and the validation cohort. Results Three hundred fourteen patients underwent VCE for SSB. Multivariable analysis revealed 3 variables—age less than 54 years old (odds ratio [OR] 0.25, 95% confidence interval [CI] 0.11-0.58), inpatient status with overt bleeding (OR 2.38, 95% CI 1.05-5.39), and hemoglobin less than 6.4 g/dL (OR 2.68, 95% CI 1.11-6.48) as independent predictors of a diagnosis on VCE. The performance of the scoring system in the developmental cohort (C-statistic 0.70; 95% CI 0.62-0.77) and the validation cohort (C-statistic 0.69; 95% CI 0.61-0.75) was not significantly different (P = 0.91). Conclusions For patients with suspected small bowel bleeding, age older than 54 years, hemoglobin

Background and Aims There is a lack of consensus on which GI endoscopic procedures should be performed during the COVID-19 pandemic, and which procedures could be safely deferred without having a significant impact on outcomes. Methods We selected a panel of 14 expert endoscopists. We identified 41 common indications for advanced endoscopic procedures from the ASGE Appropriate Use of GI Endoscopy guidelines. Using a modified Delphi method, we first achieved consensus on the patient-important outcome for each procedural indication. Panelists prioritized consensus patient-important outcome when categorizing each indication into one of the following 3 procedural time periods: (1) time-sensitive emergent (schedule within 1 week), (2) time-sensitive urgent (schedule within 1 to 8 weeks), and (3) non-time sensitive (defer for >8 weeks and then reassess the timing). Three anonymous rounds of voting were allowed before attempts at consensus were abandoned. Results All 14 invited experts agreed to participate in the study. The prespecified consensus threshold of 51% was achieved for assigning patient-important outcome(s) to each advanced endoscopy indication. The prespecified consensus threshold of 66.7% was achieved for 40 of 41 advanced endoscopy indications in stratifying them into 1 of 3 procedural time periods. For 12 of 41 indications, 100% consensus was achieved; for 20 of 41 indications, 75% to 99% consensus was achieved. Conclusions By using a Modified Delphi method that prioritized patient-important outcomes, we developed consensus recommendations on procedural timing for common indications for advanced endoscopy. These recommendations and the structured decision framework provided by our study can inform decision making as endoscopy services are reopened.

BACKGROUND AND AIMS: The potential for transmission of pathogenic organisms is a problem inherent to the current reusable duodenoscope design. Recent outbreaks of multidrug-resistant pathogenic organisms transmitted via duodenoscopes has brought to light the urgency of this problem. Microbiologic culturing of duodenoscopes and reprocessing with repeat high-level disinfection (HLD) or liquid chemical sterilization (LCS) have been offered as supplemental measures to enhance duodenoscope reprocessing by the U.S. Food and Drug Administration. This study aims to compare the efficacy of reprocessing duodenoscopes with double HLD (DHLD) versus LCS. METHODS: We prospectively evaluated 2 different modalities of duodenoscope reprocessing from October 23, 2017 to September 24, 2018. Eligible duodenoscopes were randomly segregated to be reprocessed by either DHLD or LCS. Duodenoscopes were randomly cultured after reprocessing for surveillance based on an internal protocol. RESULTS: During the study period, there were 878 post-reprocessing surveillance cultures (453 in the DHLD group and 425 in the LCS group). Of all cultures, 17 were positive for any organism (1.9%). There was no significant difference of positive cultures when comparing the duodenoscopes undergoing DHLD (8 positive cultures, 1.8%) with duodenoscopes undergoing LCS (9 positive cultures, 2.1%; P = .8). Both groups had 2 cultures that grew high-concern organisms (.5% vs .5%, P = 1.0). No multidrug-resistant organisms, including carbapenem-resistant enterobacteriaceae, were detected. CONCLUSIONS: DHLD and LCS both resulted in a low rate of positive cultures, for all organisms and for high-concern organisms. However, neither process completely eliminated positive cultures from duodenoscopes reprocessed with 2 different supplemental reprocessing strategies.

Purpose: To report a case of ocular dirofilariasis causing extensive chorio-retinal damage.Method: Surgical removal of the worm and identification of the same by microscopic examinationand polymerase chain reaction.Results: The worm was identified as Dirofilaria repens.Conclusion: Ocular dirofilariasis is an arthropod borne parasitic infestation affecting the subconjunctival tissue and anterior chamber. Vitreous involvement in Dirofilaria is very rare. Dirofilaria repens can cause extensive chorio-retinal damage resembling diffuse unilateralsubacute neuroretinitis.

In patients with borderline resectable pancreatic cancer (BRPC) or locally advanced pancreatic cancer (LAPC) who undergo neoadjuvant therapy, CT imaging is the standard of care for restaging. However, differentiating residual tumor from post-treatment inflammation with CT is unreliable. The diagnosis of periarterial soft tissue cuffing (PSTC) near major vessels is key to guiding resectability. The goal of this study was to assess the utility of EUS-FNA in determining the etiology of PSTC in BRPC or LAPC after neoadjuvant treatment. We performed a retrospective analysis of patients referred for EUS-FNA of PSTC following downstaging therapy for LAPC or BRPC at our tertiary medical center. Negative EUS-FNA cytology results were compared with surgical pathology after resection. Patients with positive EUS-FNA cytology results were either followed clinically or results were compared to surgical pathology if surgery was attempted despite the positive cytology. Fourteen patients were included in the study of whom four had positive cytology. Two of these patients had progression of disease, and two had attempted resection with positive surgical pathology (100% true positives). All ten patients with negative cytology underwent attempted surgical resection. Nine patients (90%) achieved negative margins, and one patient (10%) had a positive surgical margin. The sensitivity, specificity, and accuracy of EUS-FNA for determining resectability were 80%, 100%, and 92.9%, respectively. In this series of patients with BRPC or LAPC and persistent PSTC after downstaging neoadjuvant treatment, EUS-FNA accurately determined surgical resectability and should be considered as part of the evaluation of such patients.

Background and Aims Surveillance endoscopy is recommended after endoscopic eradication therapy (EET) for Barrett’s esophagus (BE) because of the risk of recurrence. Currently recommended biopsy protocols are based on expert opinion and consist of sampling visible lesions followed by random 4-quadrant biopsy sampling throughout the length of the original BE segment. Despite this protocol, some recurrences are not visibly identified. We aimed to identify the anatomic location and histology of recurrences after successful EET with the goal of developing a more efficient and evidence-based surveillance biopsy protocol. Methods We performed an analysis of a large multicenter database of 443 patients who underwent EET and achieved complete eradication of intestinal metaplasia (CE-IM) from 2005 to 2015. The endoscopic location of recurrence relative to the squamocolumnar junction (SCJ), visible recurrence identified during surveillance endoscopy, and time to recurrence after CE-IM were assessed. Results Fifty patients with BE recurrence were studied in the final analysis. Seventeen patients (34%) had nonvisible recurrences. In this group, biopsy specimens demonstrating recurrence were taken from within 2 cm of the SCJ in 16 of these 17 patients (94%). Overall, 49 of 50 recurrences (98%) occurred either within 2 cm of the SCJ or at the site of a visible lesion. Late recurrences (>1 year) were more likely to be visible than early ( Conclusions Recurrence after EET detected by random biopsy sampling is identified predominately in the distal esophagus and occurs earlier than visible recurrences. As such, we suggest a modified biopsy protocol with targeted sampling of visible lesions followed by random biopsy sampling within 2 cm of the SCJ to optimize detection of recurrence after EET. (Clinical trial registration number: NCT02634645.)

Guidelines recommend that patients with non-dysplastic Barrett's esophagus (NDBE) undergo surveillance endoscopy every 3-5 years. Using a national registry, we assessed compliance to recommended surveillance intervals in patients with NDBE and identified factors associated with compliance.We analyzed data from the GI Quality Improvement Consortium registry. Data abstracted include procedure indication, demographics, endoscopy/pathology results, and recommendations for future endoscopy. Patients with an indication of Barrett's esophagus (BE) screening or surveillance, or an endoscopic finding of BE, with non-dysplastic intestinal metaplasia on pathological examination, were included. Compliance was defined as a recommendation to undergo subsequent endoscopy between 3 and 5 years. Multivariate logistic regression was conducted to assess variables associated with compliance.Of 786,712 endoscopies assessed, 58,709 (7.5%) endoscopies in 53,541 patients met inclusion criteria (mean age 61.3 years, 60.4% men, 90.2% white, mean BE length was 2.3 cm). Most cases were performed by Gastroenterologists (92.3%) with propofol (78.7%). A total of 29,978 procedures (55.8%) resulted in pathology-confirmed BE. Among procedures with NDBE (n = 25,945), 29.9% were noncompliant with the 3-year threshold; most (26.9%) recommended surveillance at 1- to 2-year intervals. Patient factors such as extremes of age, black race, geographic region, type of sedation, and increasing BE length were associated with noncompliance.Approximately 30% of patients with NDBE are recommended to undergo surveillance endoscopy too soon. Patient factors associated with inappropriate utilization include extremes of age, black race, and increasing BE length. Compliance with appropriate endoscopic follow-up as a quality measure in BE is poor.

Introduction : The management of pancreaticobiliary disorders relies heavily on endoscopic retrograde cholangiopancreatography, which is performed with a duodenoscope. Bacterial colonization of reusable duodenoscopes leading to subsequent infectious outbreaks is well recognized and remains an issue despite efforts to optimize best practices in high level disinfection. The EXALT Model D duodenoscope (EXALT) (Boston Scientific Corporation, Marlborough, MA) is a single-use device, designed to achieve technical equivalency with reusable devices while eliminating the potential for device related outbreaks. Areas covered : This review covers the challenges associated with reprocessing duodenoscopes and the development of duodenoscope-related infections, with an emphasis on the use of single-use duodenoscopes as a potential solution to this issue. Expert opinion : Duodenoscope-related infections are an increasingly recognized problem. Infectious outbreaks harm patients, significantly affect providers and medical centers, and can erode patient trust in the healthcare system. Single use duodenoscopes eliminate both the risk of device related infection transmission and the need for burdensome duodenoscope reprocessing. In clinical evaluations, the EXALT device has demonstrated an equivalent technical performance and provider satisfaction compared to reusable duodenoscopes. Increasing use of this device will clarify how it compares to reusable duodenoscopes in a variety of clinical settings among endoscopists of varying skills levels.

Endoscopic eradication therapy (EET) is recommended for patients with Barrett's esophagus (BE)-associated neoplasia and is effective in achieving complete eradication of intestinal metaplasia (CE-IM). However, BE that is refractory to EET, defined as partial or no improvement in dysplasia after less than or equal to 3 ablative sessions, and the development of recurrence post-EET is not uncommon. Identification of refractory BE or recurrent intestinal metaplasia should prompt esophageal physiologic testing and modification of antireflux strategy, as appropriate. In patients who ultimately fail standard EET despite optimization of reflux control, salvage EET with alternate modalities may need to be considered.

Introduction Population-based estimates of adherence to Barrett's esophagus (BE) guidelines are not available. Using a national registry, we assessed surveillance intervals for patients with normal and irregular Z-lines based on the presence or absence of intestinal metaplasia (IM) and among patients with suspected or confirmed BE. Methods We analyzed data from the GI Quality Improvement Consortium Registry. Endoscopy data, including procedure indication, demographics, endoscopy and histology findings, and recommendations for further endoscopy, were assessed from January 2013 through December 2019. Patients with an indication of BE screening or surveillance or an endoscopic finding of BE were included. Biopsy and surveillance practices were assessed based on the length of columnar epithelium (0 cm, 3 cm) and diagnosis based on histology findings. Results A total of 1,907,801 endoscopies were assessed; 135,704 endoscopies (7.1%) performed in 114,894 patients met the inclusion criteria (men 61.4%, Whites 91%, and mean age of 61.7 years [SD 12.5]). Among patients with normal Z-lines, surveillance endoscopy was recommended for 81% of patients with IM and 20% of individuals without IM. Among patients with irregular Z-lines, surveillance endoscopy was recommended for 81% with IM and 24% without IM. Approximately 30% of patients with confirmed nondysplastic BE (lengths 1-3 and >3 cm) had recommended surveillance intervals of Discussion An analysis of data from a nationwide quality registry demonstrated that patients without BE are receiving recommendations for surveillance endoscopies and many patients with nondysplastic BE are reexamined too soon.

Background & Aims The prevalence and significance of digestive manifestations in coronavirus disease 2019 (COVID-19) remain uncertain. We aimed to assess the prevalence, spectrum, severity, and significance of digestive manifestations in patients hospitalized with COVID-19. Methods Consecutive patients hospitalized with COVID-19 were identified across a geographically diverse alliance of medical centers in North America. Data pertaining to baseline characteristics, symptomatology, laboratory assessment, imaging, and endoscopic findings from the time of symptom onset until discharge or death were abstracted manually from electronic health records to characterize the prevalence, spectrum, and severity of digestive manifestations. Regression analyses were performed to evaluate the association between digestive manifestations and severe outcomes related to COVID-19. Results A total of 1992 patients across 36 centers met eligibility criteria and were included. Overall, 53% of patients experienced at least 1 gastrointestinal symptom at any time during their illness, most commonly diarrhea (34%), nausea (27%), vomiting (16%), and abdominal pain (11%). In 74% of cases, gastrointestinal symptoms were judged to be mild. In total, 35% of patients developed an abnormal alanine aminotransferase or total bilirubin level; these were increased to less than 5 times the upper limit of normal in 77% of cases. After adjusting for potential confounders, the presence of gastrointestinal symptoms at any time (odds ratio, 0.93; 95% CI, 0.76–1.15) or liver test abnormalities on admission (odds ratio, 1.31; 95% CI, 0.80–2.12) were not associated independently with mechanical ventilation or death. Conclusions Among patients hospitalized with COVID-19, gastrointestinal symptoms and liver test abnormalities were common, but the majority were mild and their presence was not associated with a more severe clinical course.

Over the past 2 decades, in hospital centers worldwide, there have been numerous outbreaks of multidrug-resistant organisms that have since been attributed to endoscopic transmission of the infections between patients, primarily from duodenoscopes. These outbreaks have focused the attention of endoscope manufacturers, professional societies, and regulatory agencies on improving the reprocessing of these devices. The key steps in this process are point-of-use precleaning, leak testing, manual cleaning, high-level disinfection, and finally drying and storage. The promise of these initial efforts suggest that the aim of minimizing and ultimately eliminating events of endoscope-/duodenoscope-associated transmission of infectious organisms between patients can be achieved.

The COVID-19 pandemic has had a profound impact on provision of endoscopy services globally as staff and real estate were repurposed. As we begin to recover from the pandemic, a cohesive international approach is needed, and guidance on how to resume endoscopy services safely to avoid unintended harm from diagnostic delays. The aim of these guidelines is to provide consensus recommendations that clinicians can use to facilitate the swift and safe resumption of endoscopy services. An evidence-based literature review was carried out on the various strategies used globally to manage endoscopy during the COVID-19 pandemic and control infection. A modified Delphi process involving international endoscopy experts was used to agree on the consensus statements. A threshold of 80% agreement was used to establish consensus for each statement. 27 of 30 statements achieved consensus after two rounds of voting by 34 experts. The statements were categorised as pre-endoscopy, during endoscopy and postendoscopy addressing relevant areas of practice, such as screening, personal protective equipment, appropriate environments for endoscopy and infection control precautions, particularly in areas of high disease prevalence. Recommendations for testing of patients and for healthcare workers, appropriate locations of donning and doffing areas and social distancing measures before endoscopy are unique and not dealt with by any other guidelines. This international consensus using a modified Delphi method to produce a series of best practice recommendations to aid the safe resumption of endoscopy services globally in the era of COVID-19. ispartof: GUT vol:69 issue:11 pages:1915-1924 ispartof: location:England status: published

We report the case of a 63-year-old man who underwent MRI and Ga-PSMA-11 PET/CT for biochemical recurrence localization after radical prostatectomy (serum PSA, 0.25 ng/mL) and describe the incidental discovery of a rectal adenocarcinoma. Immunohistochemical analysis showed PSMA staining in the tumor-associated neovasculature, but not in normal vasculature, or tumor cells. After surgical removal, he was treated with salvage radiotherapy to the postoperative prostate bed. This case example has several implications: the findings confirm the expression of PSMA in the tumor-associated neovasculature of a rectal cancer, nonprostate cancers' stroma may represent a potentially relevant target for nuclear theranostics.

The American Gastroenterological Association's Center for Gastrointestinal Innovation and Technology convened a consensus conference in December 2018, entitled, "Colorectal Cancer Screening and Surveillance: Role of Emerging Technology and Innovation to Improve Outcomes." The goal of the conference, which attracted more than 60 experts in screening and related disciplines, including the authors, was to envision a future in which colorectal cancer (CRC) screening and surveillance are optimized, and to identify barriers to achieving that future. This White Paper originates from that meeting and delineates the priorities and steps needed to improve CRC outcomes, with the goal of minimizing CRC morbidity and mortality. A one-size-fits-all approach to CRC screening has not and is unlikely to result in increased screening uptake or desired outcomes owing to barriers stemming from behavioral, cultural, and socioeconomic causes, especially when combined with inefficiencies in deployment of screening technologies. Overcoming these barriers will require the following: efficient utilization of multiple screening modalities to achieve increased uptake; continued development of noninvasive screening tests, with iterative reassessments of how best to integrate new technologies; and improved personal risk assessment to better risk-stratify patients for appropriate screening testing paradigms.

Endoscopy units face numerous challenges because of rising demand, increased operational costs, and declining reimbursement. These conditions have led to a critical need to maximize the operational cost-efficiency of these units. Several key factors can affect the cost-efficiency of an endoscopy unit, and the 4 key areas discussed in this article are managing capital costs, efficient use of disposables, improving unit efficiency, and creating a positive culture and establishing strong unit leadership. Areas on which to focus to achieve the greatest results will vary based on specific unit characteristics, but initial efforts should aim to improve operations by focusing on 1 to 2 key areas that ideally have been identified by an internal needs assessment. Although such efforts can be arduous and need to be sustained, they can result in significant benefits to patients, endoscopy unit staff, and healthcare organizations.

Multidrug-resistant infectious outbreaks associated with duodenoscope reuse have been documented internationally. A single-use endoscope could eliminate exogenous patient-to-patient infection associated with ERCP.We conducted a comparative bench simulation study of a new single-use and 3 models of reusable duodenoscopes on a synthetic anatomic bench model. Four ERCP tasks were performed: guidewire locking (single-use and 1 reusable duodenoscope only), plastic stent placement and removal, metal stent placement and removal, and basket sweeping. The study schedule included block randomization by 4 duodenoscopes, 4 tasks, and 2 anatomic model ERCP stations. Ability to complete tasks, task completion times, and subjective ratings of overall performance, navigation/pushability, tip control, and image quality on a scale of 1 (worst) to 10 (best) were compared among duodenoscopes.All 4 ERCP tasks (total 14 subtasks) were completed by 6 expert endoscopists using all 4 duodenoscopes, with similar task completion times (median, 1.5-8.0 minutes per task) and overall performance ratings by task (median, 8.0-10.0). Navigation/pushability ratings were lower for the single-use duodenoscope than for the 3 reusable duodenoscopes (median, 8.0, 10.0, 9.0, and 9.0, respectively; P .01). Tip control ratings were similar among all the duodenoscopes (median, 9.0-10.0; P = .77). Image quality ratings were lower for 1 reusable duodenoscope compared with the single-use and other 2 reusable duodenoscopes (median, 8.0, 9.0, 9.0, and 9.0, respectively; P .01).A new single-use duodenoscope was used to simulate 4 ERCP tasks in an anatomic model, with performance ratings and completion times comparable with 3 models of reusable duodenoscopes.

Background & Aims Disposable, single-use duodenoscopes might reduce outbreaks of infections associated with endoscope reuse. We tested the feasibility, preliminary safety, and performance of a new single-use duodenoscope in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Methods We conducted a case-series study of the outcomes of ERCP with a single-use duodenoscope from April through May 2019 at 6 academic medical centers. We screened consecutive patients (18 years and older) without alterations in pancreaticobiliary anatomy and enrolled 73 patients into the study. Seven expert endoscopists performed roll-in maneuvers (duodenoscope navigation and visualization of duodenal papilla only) in 13 patients and then ERCPs in the 60 other patients. Outcomes analyzed included completion of ERCP for the intended clinical indication, crossover from a single-use duodenoscope to a reusable duodenoscope, endoscopist performance ratings of the device, and serious adverse events (assessed at 72 hours and 7 days). Results Thirteen (100%) roll-in maneuver cases were completed using the single-use duodenoscope. ERCPs were of American Society for Gastrointestinal Endoscopy procedural complexity grade 1 (least complex; 7 patients [11.7%]), grade 2 (26 patients [43.3%]), grade 3 (26 patients [43.3%]), and grade 4 (most complex; 1 patient [1.7%]). Fifty-eight ERCPs (96.7%) were completed using the single-use duodenoscope only and 2 ERCPs (3.3%) were completed using the single-use duodenoscope followed by crossover to a reusable duodenoscope. Median overall satisfaction was 9 out of 10. Three patients developed post-ERCP pancreatitis, 1 patient had post-sphincterotomy bleeding, and 1 patient had worsening of a preexisting infection and required rehospitalization. Conclusions In a case-series study, we found that expert endoscopists can complete ERCPs of a wide range of complexity using a single-use duodenoscope for nearly all cases. This alternative might decrease ERCP-related risk of infection. Clinicaltrials.gov no: NCT03701958 .

BACKGROUND: Published guidelines do not address what the minimum incremental diagnostic yield (IDY) for detection of dysplasia/cancer is required over the standard Seattle protocol for an advanced imaging modality (AIM) to be implemented in routine surveillance of Barrett’s esophagus (BE) patients. We aimed to report expert practice patterns and attitudes, specifically addressing the minimum IDY in the use of AIMs in BE surveillance. METHODS: An international group of BE experts completed an anonymous electronic survey of domains relevant to surveillance practice patterns and use of AIMs. The evaluated AIMs were conventional chromoendoscopy (CC), virtual chromoendoscopy (VC), volumetric laser endomicroscopy (VLE), confocal laser endomicroscopy (CLE), and wide-area transepithelial sampling (WATS(3D)). Responses were recorded using five-point balanced Likert items and analyzed as continuous variables. RESULTS: The survey response rate was 84% (61/73)—41 US and 20 non-US. Experts were most comfortable with and routinely use VC and CC, and least comfortable with and rarely use VLE, CLE, and WATS(3D). Experts rated data from randomized controlled trials (1.4 ± 0.9) and guidelines (2.6 ± 1.2) as the two most influential factors for implementing AIMs in clinical practice. The minimum IDY of AIMs over standard biopsies to be considered of clinical benefit was lowest for VC (15%, IQR 10–29%) and highest for VLE (30%, IQR 20–50%). Compared to US experts, non-US experts reported higher use of CC for BE surveillance (p < 0.001). CONCLUSION: These results should inform benchmarks that need to be met for guidelines to recommend the routine use of AIMs in the surveillance of BE patients.

Background and Objectives: We present a multicenter study of a new endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) needle (Acquire, Boston Scientific, Natick, MA). The aim of the study was to analyze the needle's clinical performance when sampling solid lesions and to assess the safety of this device. Methods: We performed a multicenter retrospective study of patients undergoing EUS-FNB during July 1–November 15, 2016. Results: Two hundred patients (121 males and 79 females) underwent EUS-FNB of solid lesions with the Acquire needle. Lesions included solid pancreatic masses (n = 109), adenopathy (n = 45), submucosal lesions (n = 34), cholangiocarcinoma (n = 8), liver lesions (n = 6), and other (n = 8). Mean lesion size was 30.6 mm (range: 3–100 mm). The mean number of passes per target lesion was 3 (range: 1–7). Rapid onsite cytologic evaluation (ROSE) by a cytologist was performed in all cases. Tissue obtained by EUS-FNB was adequate for evaluation and diagnosis by ROSE in 197/200 cases (98.5%). Data regarding the presence or absence of a core of tissue obtained after EUS-FNB were available in 145/200 procedures. In 131/145 (90%) of cases, a core of tissue was obtained. Thirteen out of 200 patients (6.5%) underwent some form of repeat EUS-based tissue acquisition after EUS-FNB with the Acquire needle. There were no adverse events. Conclusion: Overall, this study showed a high rate of tissue adequacy and production of a tissue core with this device with no adverse events seen in 200 patients. Comparative studies of different FNB needles are warranted in the future to help identify which needle type and size is ideal in different clinical settings.

Endoscopic ultrasound-guided tissue acquisition (EUS-TA) is safe and has a high diagnostic yield. Multiple factors affect the outcome of EUS-TA such as operator experience, procedure technique, needle-type, and cytopathologist training and experience. There have been numerous advances aiming to increase the diagnostic yield of EUS-TA. These include novel devices, modified tissue acquisition techniques, enhancements in EUS imaging, improved tissue processing methods, and increasingly frequent molecular and genetic testing of acquired tissue. Importantly, recent advances in personalized medicine may require greater amounts of tissue to be acquired to guide subsequent oncotherapy. As a result of all these new developments, several additional questions have arisen including defining the precise role of EUS-guided fine-needle biopsy, the optimal technique for EUS-TA, and standardization of tissue processing protocols. This review discusses recent advances and future directions regarding EUS-TA.

Background Carbapenem-resistant Klebsiella pneumoniae infections are increasingly prevalent in North American hospitals. We describe an outbreak of carbapenem-resistant K. pneumoniae containing the blaOXA-232 gene transmitted by contaminated duodenoscopes during endoscopic retrograde cholangiopancreatography (ERCP) procedures. Methods An outbreak investigation was performed when 9 patients with blaOXA-232 carbapenem-resistant K. pneumoniae infections were identified at a tertiary care hospital. The investigation included 2 case-control studies, review of duodenoscope reprocessing procedures, and culture of devices. Carbapenem-resistant Enterobacteriacieae (CRE) isolates were evaluated with polymerase chain reaction analysis for carbapenemase genes, and isolates with the blaOXA-232 gene were subjected to whole-genome sequencing and chromosome single-nucleotide polymorphism analysis. On recognition of ERCP as a key risk factor for infection, targeted patient notification and CRE screening cultures were performed. Results Molecular testing ultimately identified 17 patients with blaOxa-232 carbapenem-resistant K. pneumoniae isolates, including 9 with infections, 7 asymptomatic carriers who had undergone ERCP, and 1 additional patient who had been hospitalized in India and was probably the initial carrier. Two case-control studies established a point-source outbreak associated with 2 specific duodenoscopes. A field investigation of the use, reprocessing, and storage of deuodenoscopes did not identify deviations from US Food and Drug Administration or manufacturer recommendations for reprocessing. Conclusions This outbreak demonstrated the previously underappreciated potential for duodenoscopes to transmit disease, even after undergoing high-level disinfection according to manufacturers' guidelines.

Background Conflicting data exist with regard to recurrence rates of intestinal metaplasia (IM) and dysplasia after achieving complete eradication of intestinal metaplasia (CE-IM) in Barrett’s esophagus (BE) patients. Aim (i) To determine the incidence of recurrent IM and dysplasia achieving CE-IM and (ii) to compare recurrence rates between treatment modalities [radiofrequency ablation (RFA) with or without endoscopic mucosal resection (EMR) vs stepwise complete EMR (SRER)]. Methods A systematic search was performed for studies reporting on outcomes and estimates of recurrence rates after achieving CE-IM. Pooled incidence [per 100-patient-years (PY)] and risk ratios with 95 %CI were obtained. Heterogeneity was measured using the I 2 statistic. Subgroup analyses, decided a priori, were performed to explore heterogeneity in results. Results A total of 39 studies were identified (25-RFA, 13-SRER, and 2 combined). The pooled incidence of any recurrence was 7.5 (95 %CI 6.1 – 9.0)/100 PY with a pooled incidence of IM recurrence rate of 4.8 (95 %CI 3.8 – 5.9)/100 PY, and dysplasia recurrence rate of 2.0 (95 %CI 1.5 – 2.5)/100 PY. Compared to the SRER group, the RFA group had significantly higher overall [8.6 (6.7 – 10.5)/100 PY vs. 5.1 (3.1 – 7)/100 PY, P = 0.01] and IM recurrence rates [5.8 (4.3 – 7.3)/100 PY vs. 3.1 (1.7 – 4)/100 PY, P Conclusion The results of this study demonstrate that the incidence rates of overall, IM, and dysplasia recurrence rates post-EET are not inconsiderable and reinforce the importance of close surveillance after achieving CE-IM.

Biliary strictures are considered indeterminate when evaluation with imaging and standard tissue sampling during endoscopic retrograde cholangiopancreatography (ERCP) are non-diagnostic. Standard tissue sampling techniques include cytologic brushings, with or without fluorescence in situ hybridization (FISH), and endoscopic intraductal biopsies. These strictures are often clinically suspicious for malignancy. The management of these patients can vary substantially and relies on an accurate diagnosis of the lesion. Unfortunately, despite numerous modalities, the sensitivity of existing tissue sampling techniques remains low and can lead to delays in diagnosis and the need for additional procedures. Cholangioscopy has emerged as a means to visually inspect and obtain image-guided biopsies of the lesion in question, with improved sensitivity as well as a high specificity and accuracy for diagnosing the etiology of indeterminate biliary strictures. The types of cholangioscopy systems and a summary of the pertinent literature are discussed in this review.

Background and aims Precut papillotomy is widely used after failed biliary cannulation. Endoscopic ultrasound (EUS)-guided biliary access techniques are newer methods to facilitate access and therapy in failed cannulation. We evaluated the impact of EUS-guided biliary access on endoscopic retrograde cholangiopancreatography (ERCP) success and compared these techniques to precut papillotomy. Patients and methods We retrospectively compared two ERCP cohorts. One cohort consisted of biliary ERCPs (n = 1053) attempted in patients with native papillae and surgically unaltered anatomy in whom precut papillotomy and/or EUS-guided biliary access were routinely performed immediately after failed cannulation. This cohort was compared with a similar ERCP cohort (n = 1062) in which only precut papillotomy was available for failed cannulation. The following outcomes were compared: conventional cannulation success, rates of attempted advanced access techniques (precut or EUS), precut success, EUS-guided biliary access success, and ERCP failure rates. Results Although conventional cannulation success, rates of attempted advanced access technique (precut or EUS), and precut success were similar, the ERCP failure rate was lower when both EUS-guided biliary access and precut were available (1.0 % [95 % confidence interval (CI) 0.4 – 1.6]), compared with when only precut was possible for failed access (3.6 % [95 %CI 2.5 – 4.7]; P Conclusions EUS-guided biliary access decreases the rate of therapeutic biliary ERCP failure. Our results support the use of EUS-guided biliary access to optimize single-session ERCP success. In experienced hands, these techniques appear as effective, if not more so, than precut papillotomy.

Background and Aims Certain pancreaticobiliary conditions remain challenging to treat using standard endoscopic techniques. Examples include difficult-to-remove gallstones and foreign objects in the bile ducts. Two tools designed for these purposes are the SpyGlass retrieval basket and the SpyGlass retrieval snare, which are passed through the cholangioscope channel for use under direct visualization. We present 3 cases in which these tools were used successfully. Methods Three cases using the SpyGlass retrieval basket and retrieval snare were reviewed for efficacy. Results Patient 1 had hepatitis C cirrhosis and underwent liver transplantation with T tube placement at the site of biliary anastomosis. Image-guided T tube removal by interventional radiology was unsuccessful. Endoscopic removal with the SpyGlass retrieval snare was completed. Patient 2 presented with cholangitis from an impacted common bile duct stone. Fragmentation with electrohydraulic lithotripsy was performed, and the fragments were removed with the SpyGlass retrieval basket. Patient 3 presented for removal of a migrated biliary stent. The stent was placed a year prior during an ERCP for treatment of choledocholithiasis. Initial removal attempt at an area hospital failed, so the patient was referred to our center, where the Spyglass retrieval snare was used to remove the biliary stent. Conclusions This case series demonstrates initial successes treating biliary pathologic conditions with the SpyGlass retrieval basket and retrieval snare, 2 tools designed for use under direct visualization with the cholangioscope.