Single-use Duodenoscope: The Cleaner Standard.

Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard in the endoscopic management of biliary disease. An average of 700,000 ERCPs are performed every year, and most are performed using a reusable flexible duodenoscope. The innovation of disposable duodenoscopes has changed the dynamic in the advanced endoscopy field of study to primarily reduce or eliminate the risk of cross-contamination between patients. Many factors affect whether institutions can convert from standard reusable duodenoscopes to single-use duodenoscopes including the cost of the devices, reimbursement from insurance companies for the new devices, and the overall environmental impact. However, the reduction of cross-contamination leading to active infection in patients, environmental waste produced with high-level disinfection procedures, staff and equipment required for reprocessing, and the inability to frequently upgrade duodenoscopes for optimal performance are all factors that favor transitioning to single-use duodenoscopes. As these devices are new to the field of gastroenterology, the purpose of this review is to analyze the advantages and disadvantages of transitioning to single-use devices and a brief mention of alternative options for institutions unable to make this change.

Endoscopic ultrasound-directed transgastric ERCP (EDGE): A multicenter US study on long-term follow-up and fistula closure.

Background and study aims Endoscopic ultrasound-directed transgastric ERCP (EDGE) is a safe and efficacious procedure to treat pancreaticobiliary diseases in Roux-en-Y gastric bypass (RYGB). This multicenter study aimed to determine the long-term outcomes of EDGE focusing on fistula persistence rates and post-procedure weight change. Patients and methods Information about patients with Roux-en-Y gastric bypass anatomy who underwent EDGE between 2015 and 2021 from 10 institutions was captured in a registry. Patient demographics, procedural details, and clinical outcomes were analyzed. Results One hundred seventy-two patients were included in the study (mean age 60, 25 % male). Technical success of lumen-apposing metal stent (LAMS) placement was 171 of 172 (99.4 %) while clinical success of intervention was 95%. The mean procedure time was 65 minutes. The most commonly reported complication was stent dislodgement/migration (n = 29, 17). Mean length of time of LAMS duration was 69 days. Mean follow-up time was 6 months. Endoscopic fistula closure was performed in 40 % of patients (69/172) at the time of LAMS removal. Persistence of fistula was observed in 19 of 62 patients (31 %) assessed. Length of LAMS indwell time (days) was a predictor of persistent fistula. The average weight gain while the LAMS was in place was 12 lb in 63 patients (36.6 %); 59.4 % of patients gained < 5 lb. Conclusions EDGE is a safe and efficacious procedure for RYGB patients requiring ERCP. Post-procedure evaluation and management of the enteral fistula varies widely among centers currently and would benefit from further standardization. Fistula persistence appears to be uncommon and can be managed endoscopically but may be related to length of indwell times of the LAMS.

Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes: A Multicenter Study.

INTRODUCTION: Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the safety and efficacy of the two available SDDs in the United States. METHODS: We conducted a comparative study of 2 SDD in consecutive ERCP procedures performed by expert endoscopists from 9 academic centers. Performance ratings, procedure details, and adverse events were collected. RESULTS: A total of 201 patients were included: 129 patients underwent ERCP with Exalt (mean age 63, Males- 66 (51%), 72 with aScope Duodeno (mean age 65, males=30 (42%). A majority of endoscopists had performed >2000 ERCPs in both groups (71% Exalt, 93% aScope Duodeno). Technical success was 92% in both groups (n=119 Exalt-group, n=66 aScope-Duodeno-group). The procedural complexity for the ERCP cases performed were: Grade 1: 35 cases (18%), Grade 2: 83 cases (41%), Grade 3: 65 cases (32%), and Grade 4: 18 cases (9%). Thirteen patients (10%) from the Exalt group and 16 patients (22%) from the aScope Duodeno group required conversion to a reusable duodenoscope. On a scale of 1 to 5, Exalt and aScope Duodeno, respectively, were rated: 2.31 versus 2.60 for location and visualization quality, 1.38 versus 1.57 for maneuverability based on papillary orientation, 1.48 versus 1.15 for suction/air control, and 2.31 versus 2.34 for elevator efficiency. None of the adverse events were related to the SDDs. CONCLUSIONS: The 2 SDDs were comparable. Further ongoing enhancements to these devices will improve maneuverability and clinical effectiveness.

Technical Report: Protocol for Characterizing Phenotype Variants Using Phenome-Wide Association Study (PheWAS) Utilizing the Nationwide Inpatient Sample 2020 in Individuals With Pancreatic Cysts and Lung Cancer.

This technical report serves as a comprehensive guide for conducting a phenome-wide association study (PheWAS) utilizing data extracted from the Nationwide Inpatient Sample 2020. Specifically tailored to individuals diagnosed with pancreatic cysts and lung cancer, the report establishes a step-by-step workflow designed to assist researchers in uncovering potential associations within this specific cohort. The methodology outlined in the report ensures clarity and reproducibility by employing a curated cohort sourced from the GitHub repository and executed using R for robust data analysis. The code encompasses pivotal steps, including the utilization of a QQ plot as a crucial diagnostic tool aimed at identifying systematic biases or associations. Additionally, the report incorporates the creation of a Manhattan plot, delving into essential mathematical considerations to enhance the interpretability of the results. Notably, the report elucidates the handling of the International Classification of Disease version 10 (ICD-10) codes, providing a sample approach for their segmentation to analyze associations by diagnostic categories. The segmentation aligns with the guidelines outlined in the American Medical Association's ICD-10-CM 2022, the Complete Official Codebook with Guidelines (American Medical Association Press, 2021), ensuring a standardized and rigorous analytical process. This comprehensive guide equips researchers with the tools and insights needed to navigate the complexities of PheWAS within the context of pancreatic cysts and lung cancer, fostering transparency, reproducibility, and meaningful scientific exploration.

Digital single-operator cholangioscopy interobserver study using a new classification: the Mendoza Classification (with video).

BACKGROUND AND AIMS: Digital single-operator cholangioscopy (DSOC) allows direct visualization of the biliary tree for evaluation of biliary strictures. Our objective was to assess the interobserver agreement (IOA) of DSOC interpretation for indeterminate biliary strictures using newly refined criteria. METHODS: Fourteen endoscopists were asked to review an atlas of reference clips and images of 5 criteria derived from expert consensus. They then proceeded to score 50 deidentified DSOC video clips based on the visualization of tortuous and dilated vessels, irregular nodulations, raised intraductal lesions, irregular surface with or without ulcerations, and friability. The endoscopists then diagnosed the clips as neoplastic or non-neoplastic. Intraclass correlation (ICC) analysis was done to evaluate inter-rater agreement for both criteria sets and final diagnosis. RESULTS: Clips of 41 malignant lesions and 9 benign lesions were scored. Three of 5 revised criteria had almost perfect agreement. ICC was almost perfect for presence of tortuous and dilated vessels (.86), raised intraductal lesions (.90), and presence of friability (.83); substantial agreement for presence of irregular nodulations (.71); and moderate agreement for presence of irregular surface with or without ulcerations (.44). The diagnostic ICC was almost perfect for neoplastic (.90) and non-neoplastic (.90) diagnoses. The overall diagnostic accuracy using the revised criteria was 77%, ranging from 64% to 88%. CONCLUSIONS: The IOA and accuracy rate of DSOC using the new Mendoza criteria shows a significant increase of 16% and 20% compared with previous criteria. The reference atlas helps with formal training and may improve diagnostic accuracy. (Clinical trial registration number: NCT02166099.).

Digital Cholangioscopic Interpretation: When North Meets the South.

BACKGROUND: Digital single-operator cholangioscopy (DSOC) (SpyGlass DS™, Boston Scientific, MA, USA) allows for high-definition imaging of the biliary tree. The superior visualization has led to the development of two different sets of criteria to evaluate and classify indeterminate biliary strictures: the Monaco criteria and the criteria in Carlos Robles-Medranda's publication (CRM). Our objective was to assess the interrater agreement (IA) of DSOC interpretation for indeterminate biliary strictures using the two newly published criteria. METHODS: Forty de-identified DSOC video recordings were sent to 15 interventional endoscopists with experience in cholangioscopy. They were asked to score the videos based on the presence of Monaco Classification criteria: stricture, lesion, mucosal changes, papillary projections, ulceration, white linear bands or rings, and vessels. Next, they scored the videos using CRM criteria: villous pattern, polypoid pattern, inflammatory pattern, flat pattern, ulcerate pattern and honeycomb pattern. The endoscopists then diagnosed the recordings as neoplastic or non-neoplastic based on the criteria. Intraclass correlation (ICC) analysis was done to evaluate interrater agreement for both criteria set and final diagnosis. RESULTS: Recordings of 26 malignant lesions and 14 benign lesions were scored. The IA using both the Monaco criteria and CRM criteria ranged from poor to excellent (range 0.1-0.76) and (range 0.1-0.62), respectively. Within the Monaco criteria, IA was excellent for lesion (0.75) and fingerlike papillary projections (0.74); good for tortuous vessels (0.7), mucosal features (0.62), uniform papillary projections (0.53), and ulceration (0.58); and fair for white linear bands (0.4). Within the CRM criteria, the IA was good for villous pattern (0.62), flat pattern (0.62), and honeycomb pattern; fair for ulcerated pattern (0.56), polypoid pattern (0.52) and inflammatory pattern (0.54). The diagnostic IA using Monaco criteria was good (0.65), while the diagnostic IA using CRM was fair (0.58). The overall diagnostic accuracy using the Monaco classification was 61% and CRM criteria were 57%. CONCLUSION: The IOA and accuracy rate of DSOC using visual criteria from both Monaco Criteria and CRM are similar. However, some criteria from both sets suffer from poor IA, thus affecting the overall diagnostic accuracy. More formal training and refinements in visual criteria with additional validation are needed to improve diagnostic accuracy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02166099.

Digital Single-operator Cholangioscopy (DSOC) Improves Interobserver Agreement (IOA) and Accuracy for Evaluation of Indeterminate Biliary Strictures: The Monaco Classification.

BACKGROUND: Visual characteristics seen during digital single-operator cholangioscopy (DSOC) have not been validated. The aim of this 2-phase study was to define terminology by consensus for the visual diagnosis of biliary lesions to develop a model for optimization of the diagnostic performance of DSOC. MATERIALS AND METHODS: In phase 1 (criteria identification), video-cholangioscopy clips were reviewed by 12 expert biliary endoscopists, who were blinded to the final diagnosis. Visual criteria were consolidated into the following categories: (1) stricture, (2) lesion, (3) mucosal features, (4) papillary projections, (5) ulceration, (6) abnormal vessels, (7) scarring, (8) pronounced pit pattern.During the second phase (validation), 14 expert endoscopists reviewed DSOC (SpyGlass DS, Boston Scientific) clips using the 8 criteria to assess interobserver agreement (IOA) rate. RESULTS: In phase 1, consensus for visual findings were categorized into 8 criteria titled the "Monaco Classification." The frequency of criteria were: (1) presence of stricture-75%, (2) presence of lesion type-55%, (3) mucosal features-55%, (4) papillary projections-45%, (5) ulceration-42.5%, (6) abnormal vessels-10%, (7) scarring-40%, and (8) pronounced pit pattern-10%. The accuracy on final diagnosis based on visual impression alone was 70%.In phase 2, the IOA rate using Monaco Classification criteria ranged from slight to fair. The presumptive diagnosis IOA was fair (κ=0.31, SE=0.02), and overall diagnostic accuracy was 70%. CONCLUSIONS: The Monaco classification identifies 8 visual criteria for biliary lesions on single-operator digital cholangioscopy. Using the criteria, the IOA and diagnostic accuracy rate of DSOC is improved compared with prior studies.

Comparing accuracy of high-risk features for detecting advanced neoplasia in pancreatic cystic lesions: a systematic review and meta-analysis.

BACKGROUND: The American Gastroenterological Association recommends endoscopic ultrasound (EUS) for evaluating pancreatic cystic lesions (PCL) with ≥2 high-risk features (HRF), whereas the American College of Gastroenterology recommends EUS for ≥1 HRF. This systematic review and meta-analysis compared the diagnostic accuracy of using ≥1 vs. ≥2 HRF for assessing the risk of advanced neoplasia (AN) and performing EUS in PCL. METHODS: An electronic database search was performed for eligible studies. AN was defined as pancreatic adenocarcinoma, intraductal papillary mucinous neoplasm or mucinous cystadenoma with high-grade dysplasia, pancreatic intraepithelial neoplasia and pancreatic neuroendocrine tumors. HRF included cyst size ≥3 cm, solid component, and dilated pancreatic duct ≥5 mm. The primary outcome was the sensitivity and specificity of using ≥1 vs. ≥2 HRF as an indication for EUS to detect AN in PCL. RESULTS: Of 38 studies initially screened, 8 were included in the final analysis. Seven studies assessed the accuracy of ≥2 HRF and 4 studies assessed ≥1 HRF. The pooled sensitivity, specificity, positive and negative predictive values of EUS for detecting AN were 41.7% (95% confidence interval 19.5-67.8%), 90.8% (81.9-95.5%), 30.4% (19.4-44.2%) and 94.3% (89.6-97.0%) with ≥2HRFs, and 77.1% (66.1-85.3%), 72.7% (50.4-87.5%), 17.95% (10.3-29.4%), 98.1% (90.8-99.6%), respectively, with ≥1 HRF. CONCLUSION: Performing EUS for PCL with ≥1 HRF could offer greater sensitivity in detecting AN compared to ≥2 HRF, with a similar negative predictive value.

Novel Uses of Lumen-apposing Metal Stents: A Review of the Literature.

The field of therapeutic endoscopy has seen many recent advancements. One such emerging field is the use of lumen-apposing metal stents (LAMS). Although a few LAMS have been developed, the most commonly reviewed and the only Food and Drug Administration (FDA)-approved LAMS is the Axios stent by Boston Scientific. In 2013, LAMS were initially approved by the FDA for the management of pancreatic fluid collection drainage in the presence walled-off necrosis. Pancreatic fluid collections are traditionally drained with either a plastic stent or a covered biliary self-expanding metal stent. Plastic stents have a double pigtail feature which prevents stent migration. However, their narrow lumen poses limitations as it can lead to early stent occlusion. Fully covered metal stents have larger diameters, allowing improved drainage and decreased stent occlusion but their tubular shape is prone to migration. Consequently, this results in leakage, and frequent retrievals. Over the years, due to their versatility, LAMS now have many off label uses. This includes management of gastric outlet obstruction, superior mesenteric artery syndrome, strictures, gallbladder drainage, and postsurgical collection drainage. In this review, we will be discussing the FDA approved and the nonapproved uses of LAMS.

Confocal endomicroscopy for evaluation of pancreatic cystic lesions: a systematic review and international Delphi consensus report.

Background and study aims The aim of thi systematic review and consensus report is to standardize the practice of endoscopic ultrasound (EUS-guided needle-based confocal laser endomicroscopy (nCLE) for pancreatic cystic lesion (PCL) evaluation. Methods We performed an international, systematic, evidence-based review of the applications, outcomes, procedural processes, indications, training, and credentialing of EUS-nCLE in management of PCLs. Based on available clinical evidence, preliminary nCLE consensus statements (nCLE-CS) were developed by an international panel of 15 experts in pancreatic diseases. These statements were then voted and edited by using a modified Delphi approach. An a priori threshold of 80 % agreement was used to establish consensus for each statement. Results Sixteen nCLE-CS were discussed. Thirteen (81 %) nCLE-CS reached consensus addressing indications (non-communication PCL meeting criteria for EUS-FNA or with prior non-diagnostic EUS-FNA), diagnostic outcomes (improved accuracy for mucinous PCLs and serous cystadenomas with substantial interobserver agreement of image patterns), low incidence of adverse events (fluorescein-associated and pancreatitis), procedural processes (nCLE duration, manipulation of needle with probe), and training (physician knowledge and competence). Conclusion Based on a high level of agreement pertaining to expert consensus statements, this report standardizes the practice of EUS-nCLE. EUS-nCLE should be systematically considered when EUS-FNA is indicated for PCL evaluation.

Predicting pediatric esophageal wall thickness: An EUS study.

BACKGROUND AND OBJECTIVE: EUS has been shown in two small series to be capable of documenting increases in the total esophageal wall thickness (TWT) in children and adults with eosinophilic esophagitis (EoE). To apply EUS-derived TWT in clinical situations or in scientific investigations in pediatric EoE, measurements of esophageal TWT in children of differing ages and heights are required. MATERIALS AND METHODS: Thirty patients (18M: 12F, 7 months to 20 years and 10 months) with a history of esophageal symptoms, but no endoscopic or histologic criteria of EoE were studied using a through the scope 20 MHZ Olympus Ultrasound miniprobe UM-3R (Olympus America, Center Valley Pa 18034) through a GIF Q180 or 160 (Olympus) standard pediatric upper endoscope. The mucosa, the mucosa plus submucosa, and the TWT were measured in the mid- and distal esophagus immediately before taking diagnostic biopsies. RESULTS: Measurements from both sites showed a statistically significant increase in TWT as a function of age (P < 0.001) and height (P < 0.001), as did the individual layers. The width of the mucosa and the submucosa were equivalent and together, they contributed more than half of the entire TWT. There were no significant differences between the means of the mid- and distal esophageal measurements. A multiple regression equation that can predict TWT based on age, with 95% confidence limits, is presented. CONCLUSIONS: EUS has demonstrated that esophageal TWT in a cohort of control children correlates with height and with age and has provided insights into the organization of the esophageal wall. Esophageal TWT values obtained by EUS can now be interpreted to recognize esophageal wall thickening throughout childhood.

An international, multi-institution survey of the use of EUS in the diagnosis of pancreatic cystic lesions.

BACKGROUND AND OBJECTIVES: Currently, pancreatic cystic lesions (PCLs) are recognized with increasing frequency and have become a more common finding in clinical practice. EUS is challenging in the diagnosis of PCLs and evidence-based decisions are lacking in its application. This study aimed to develop strong recommendations for the use of EUS in the diagnosis of PCLs, based on the experience of experts in the field. METHODS: A survey regarding the practice of EUS in the evaluation of PCLs was drafted by the committee member of the International Society of EUS Task Force (ISEUS-TF). It was disseminated to experts of EUS who were also members of the ISEUS-TF. In some cases, percentage agreement with some statements was calculated; in others, the options with the greatest numbers of responses were summarized. RESULTS: Fifteen questions were extracted and disseminated among 60 experts for the survey. Fifty-three experts completed the survey within the specified time frame. The average volume of EUS cases at the experts' institutions is 988.5 cases per year. CONCLUSION: Despite the limitations of EUS alone in the morphologic diagnosis of PCLs, the results of the survey indicate that EUS-guided fine-needle aspiration is widely expected to become a more valuable method.

The Utility of Endoscopic Ultrasound in Patients with Isolated Elevations in Serum Amylase and/or Lipase.

BACKGROUND/AIMS: The aim of this study was to describe the diagnostic yield of endoscopic ultrasound (EUS) in patients with isolated elevated levels of amylase and/or lipase. METHODS: A retrospective chart review was conducted at a large academic medical center from 2000 to 2016. Patients were selected based on having elevated amylase, lipase, or both, but without a diagnosis of pancreatitis or known pancreatobiliary disease. Patients were excluded if they had abnormal liver function tests or abnormal imaging of the pancreas. RESULTS: Of 299 EUS procedures performed, 38 met inclusion criteria. Symptoms were present in 31 patients, most frequently abdominal pain (87%). In 20 patients (53%), initial EUS most commonly found chronic pancreatitis (n=7; 18%), sludge (5; 13%), or new diagnosis of pancreas divisum (3; 8%). In the asymptomatic patients (7), 3 had a finding on EUS, most importantly sludge (2), stone (1), and pancreas divisum (1). No patients were diagnosed with a mass or pancreatic cyst. During the follow up period, 6 patients (22%) had cholecystectomy. CONCLUSION: In our study of patients with isolated elevations in amylase and/or lipase without acute pancreatitis who underwent EUS, approximately 50% had a pancreatobiliary finding, most commonly chronic pancreatitis or biliary sludge.

Digital Pancreaticocholangioscopy for Mapping of Pancreaticobiliary Neoplasia: Can We Alter the Surgical Resection Margin?

INTRODUCTION: In patients with pancreaticobiliary lesions anticipating surgical resection, digital pancreaticocholangioscopy can be used to identify the extent of disease. This presurgical"mapping" could change the surgical plan and optimize patient care. MATERIALS AND METHODS: Patients with pancreaticobiliary lesions anticipating surgery who underwent endoscopic retrograde cholangiopancreatography with digital pancreaticocholangioscopy from 9 international centers were included. Primary outcome was whether pancreaticocholangioscopy altered the surgical plan. Secondary outcome was correlation between surgical and endoscopic histology and adverse events. RESULTS: A total of 118 patients were included (64% male, mean age 69 y): cholangioscopy in 105 patients (89%), pancreatoscopy in 13 patients (11%). Pancreaticocholangioscopy changed the surgical plan in 39 (34%) of patients: 8 of 13 in the pancreatic duct, 32 of 105 in the bile duct. In the bile duct, 6 patients (5%) had less extensive surgery, 26 patients (25%) avoided surgery. In the pancreatic duct, 4 patients (31%) had more extensive surgery and 4 patients (31%) had less extensive surgery. Four patients with downstaged surgery had positive margins on surgical resection; 1 required additional surgical intervention. Overall correlation between endoscopy and surgical histology was 88%. Adverse events included post endoscopic retrograde cholangiopancreatography pancreatitis in 3 patients (2.5%). CONCLUSION: Digital pancreaticocholangioscopy can be effectively used as a mapping tool to delineate the degree of involvement of biliary lesions before surgical resection, in some cases altering the surgical plan. Prospective studies are needed, especially when downstaging surgery.

Celiac Plexus Block and Neurolysis: A Review.

Pain is often associated with chronic pancreatitis and pancreatic cancer. Often times opioids are used to treat pain; however, the use of opioids is frequently difficult. Endoscopic ultrasound-guided celiac plexus block and celiac plexus nuerolysis are safe and effective modalities used to alleviate pain. Celiac plexus block is a transient interruption of the plexus by local anesthetic, while celiac plexus neurolysis is prolonged interruption of the transmission of pain from the celiac plexus using chemical ablation. Celiac plexus block is generally performed in the unilateral position, while celiac plexus neurolysis is performed in the unilateral or bilateral position.

Predictors of Progression Among Low-Risk Intraductal Papillary Mucinous Neoplasms in a Multicenter Surveillance Cohort.

OBJECTIVES: Our aim was to identify baseline characteristics associated with disease progression and malignant transformation in low-risk suspected intraductal papillary mucinous neoplasms (IPMNs). METHODS: This is a retrospective cohort study of prospectively maintained databases of pancreatic cysts at 3 international, academic institutions. Five hundred fifty-nine adult patients with clinically suspected asymptomatic IPMN evaluated by radiologic studies or endoscopic ultrasound between 2003 and 2013 without worrisome features and under surveillance for 12 months or longer were included. We evaluated the relationship of baseline demographics and cyst features to disease progression (size increase, development of worrisome features, or high-grade dysplasia/cancer). RESULTS: After a median of 44 months follow-up, 269 (48%) patients experienced cyst size increase, 68 (12%) developed worrisome features, and 11 (2%) developed high-grade dysplasia/cancer. In multivariable Cox-regression analysis, no baseline characteristics were associated with size increase. An initial cyst size of 2 cm or greater, multifocality, history of prostate cancer, and smoking were the strongest predictors of development of new worrisome features. Univariable analysis found male sex, diabetes, and recent weight loss associated with development of high-grade dysplasia/cancer. CONCLUSIONS: Our study demonstrates that low-risk suspected IPMNs carry a small but clinically relevant risk of disease progression and provides data on baseline characteristics that may help in risk stratification.