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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., Competing Interests: Competing interests Dr. Napoleon has received honoraria and grants from Mauna Kea Technologies and Boston Scientific. Dr. Krishna is currently receiving a travel grant from Mauna Kea Technologies. Dr. Marco has received honoraria and grants from Boston Scientific, Cook Medical, Pentax Medical, 3 M, and Mylan. Dr. Carr-Lock has received honoraria and grants from Mauna Kea Technologies, Boston Scientific, and US Endoscopy. Dr. Chang has received honoraria and grants from Boston Scientific, Cook Medical, Pentax Medical, NinePoint, and Erbe. Dr. Sejpal has received grants from Boston Scientific, Cook Medical, and Olympus. Dr. Palazzo has received grants from Mauna Kea Technologies. Dr. Brugge has received honoraria and grants from US Endoscopy and NinePoint., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

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., Competing Interests: None

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.

Asymptomatic pancreatic cysts are a common clinical problem but only a minority of these cases progress to cancer. Our aim was to compare the accuracy to detect malignancy of the 2015 American Gastroenterological Association (AGA), the 2012 International Consensus/Fukuoka (Fukuoka guidelines [FG]), and the 2010 American College of Radiology (ACR) guidelines.We conducted a retrospective study at 3 referral centers for all patients who underwent resection for an asymptomatic pancreatic cyst between January 2008 and December 2013. We compared the accuracy of 3 guidelines in predicting high-grade dysplasia (HGD) or cancer in resected cysts. We performed logistic regression analyses to examine the association between cyst features and risk of HGD or cancer.A total of 269 patients met inclusion criteria. A total of 228 (84.8%) had a benign diagnosis or low-grade dysplasia on surgical pathology, and 41 patients (15.2%) had either HGD (n = 14) or invasive cancer (n = 27). Of the 41 patients with HGD or cancer on resection, only 3 patients would have met the AGA guideline's indications for resection based on the preoperative cyst characteristics, whereas 30/41 patients would have met the FG criteria for resection and 22/41 patients met the ACR criteria. The sensitivity, specificity, positive predictive value, negative predictive value of HGD, and/or cancer of the AGA guidelines were 7.3%, 88.2%, 10%, and 84.1%, compared to 73.2%, 45.6%, 19.5%, and 90.4% for the FG and 53.7%, 61%, 19.8%, and 88% for the ACR guidelines. In multivariable analysis, cyst size >3 cm, compared to ≤3 cm, (odds ratio [OR] = 2.08, 95% confidence interval [CI] = 1.11, 4.2) and each year increase in age (OR = 1.07, 95% CI = 1.03, 1.11) were positively associated with risk of HGD or cancer on resection.In patients with asymptomatic branch duct-intraductal papillary mucinous neoplasms or mucinous cystic neoplasms who underwent resection, the prevalence rate of HGD or cancer was 15.2%. Using the 2015 AGA criteria for resection would have missed 92.6% of patients with HGD or cancer. The more "inclusive" FG and ACR had a higher sensitivity for HGD or cancer but lower specificity. Given the current deficiencies of these guidelines, it will be important to determine the acceptable rate of false-positives in order to prevent a single true-positive.

Background & Aims: Endoscopic ultrasound-guided transmural drainage and necrosectomy have become the standard treatment for patients with pancreatic walled-off necrosis (WON). Lumen-apposing metal stents (LAMS) have shown success in the management of pancreatic fluid collections. However, there are few data on their specific roles in management of WON. We investigated the efficacy and safety of LAMS in treatment of WON., Methods: We performed a retrospective multicenter case series of 124 patients with WON who underwent endoscopic transmural drainage by using LAMS at 17 tertiary care centers from January 2014 through May 2015. Patients underwent endoscopic ultrasound-guided cystogastrostomy or cystoenterostomy with placement of an LAMS into the WON collection. At the discretion of the endoscopist, we performed direct endoscopic necrosectomy, irrigation with hydrogen peroxide, and/or nasocystic drain placement. We performed endoscopic retrograde cholangiopancreatography with pancreatic duct stent placement when indicated. Concomitant therapies included direct endoscopic debridement (n = 78), pancreatic duct stent placement for leak (n = 19), hydrogen peroxide-assisted necrosectomy (n = 38), and nasocystic irrigation (n = 22). We collected data for a median time of 4 months (range, 1-34 months) after the LAMS placement. The primary outcomes were rates of technical success (successful placement of the LAMS), clinical success (resolution of WON, on the basis of image analysis, without need for further intervention via surgery or interventional radiology), and adverse events., Results: The median size of the WON was 9.5 cm (range, 4-30 cm). Eight patients had 2 LAMS placed for multiport access, all with technical success (100%). Clinical success was achieved in 107 patients (86.3%) after 3 months of follow-up. Thirteen patients required a percutaneous drain, and 3 required a surgical intervention to manage their WON. The stents remained patent in 94% of patients (117 of 124) and migrated in 5.6% of patients (7 of 124). The median number of endoscopic interventions was 2 (range, 1-9 interventions)., Conclusions: On the basis of a retrospective analysis of 124 patients, endoscopic therapy of WON by using LAMS is safe and effective. Creation of a large and sustained cystogastrostomy or cystoenterostomy tract is effective in the drainage and treatment of WON., (Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background and Aims: The ability to safely and effectively obtain sufficient tissue for pathologic evaluation by using endoscopic ultrasound (EUS) guidance remains a challenge. Novel designs in EUS needles may provide for improved ability to obtain such core biopsies. The aim of this study was to evaluate the diagnostic yield of core biopsy specimens obtained using a novel EUS needle specifically designed to obtain core biopsies., Patients and Methods: Multicenter retrospective review of all EUS-guided fine-needle biopsies obtained using a novel biopsy needle (SharkCore FNB needle, Medtronic, Dublin, Ireland). Data regarding patient demographics, lesion type/location, technical parameters, and diagnostic yield was obtained., Results: A total of 250 lesions were biopsied in 226 patients (Median age 66 years; 113 (50 %) male). Median size of all lesions (mm): 26 (2 - 150). Overall, a cytologic diagnosis was rendered in 81 % specimens with a median number of 3 passes. When rapid onsite cytologic evaluation (ROSE) was used, cytologic diagnostic yield was 126/149 (85 %) with a median number of 3 passes; without ROSE, cytologic diagnostic yield was 31/45 (69 %, P = 0.03) with a median number of 3 passes. Overall, a pathologic diagnosis was rendered in 130/147 (88 %) specimens with a median number of 2 passes. Pathologic diagnostic yield for specific lesion types: pancreas 70/81 (86 %), subepithelial lesion 13/15 (87 %), lymph node 26/28 (93 %). Ten patients (10/226, 4 %) experienced adverse events: 4 acute pancreatitis, 5 pain, 1 fever/cholangitis., Conclusions: Initial experience with a novel EUS core biopsy needle demonstrates excellent pathologic diagnostic yield with a minimum number of passes.

Background: Endoscopic ultrasound guided elastography is an imaging modality that can be used to evaluate tissue stiffness and to assess solid pancreatic lesions. It can also assist in optimizing the diagnostic yield of endoscopic ultrasound guided fine needle aspiration biopsies., Aims: To review the literature on solid pancreatic lesions, the use of EUS guided fine needle aspiration and endoscopic ultrasound guided elastography and to present a single center experience using elastography to direct fine needle aspiration biopsies of solid pancreatic lesions., Methods: We present a review of the literature and a single center experience describing the use of EUS guided elastography in directing fine needle aspiration biopsies of solid pancreatic lesions., Results: Thirteen male veterans with an average age of 62.3 (SD±11.8) years were enrolled in the study. The mean pancreatic mass size on EUS was 5.1×5.2 (SD±4.4×4.5) cm. A total of 13 lesions were identified during elastography. The lesions were most commonly found in the body (n=5), followed by multifocal lesions (n=4), pancreatic head (n=3) and tail (n=1). The seven concerning pancreatic lesions were stratified based on color pattern identified on EUS and EUS-elastography. Three lesions were homogenously blue, and four lesions were heterogeneously blue. The remaining six lesions which were less concerning were predominantly green. Of the three lesions, that were homogenously blue, two were diagnosed as adenocarcinoma (n=2) and chronic pancreatitis (n=1) respectively. Of the four heterogeneously blue lesions two were adenocarcinomas, while the other two represented a large B-cell lymphoma and chronic pancreatitis. Patients whose lesions were characterized as homogenous or heterogeneous green were benign and remained disease free after a median of two years of regular follow up., Limitations: Relatively small number of patients studied., Conclusions: In our single center experience we found that the use of real time endoscopic ultrasound guided elastography for targeting fine needle aspiration of suspicious pancreatic lesions may be beneficial as an adjunct modality to complement conventional EUS. Larger prospective studies need to be conducted to evaluate the utility of this modality in targeting pancreatic lesions., Competing Interests: Conflict of Interest Authors declare no conflict of interests for this article.

Background: Probe-based confocal laser endomicroscopy (pCLE) provides microscopic imaging during an endoscopic procedure. Its introduction as a standard modality in gastroenterology has brought significant progress in management strategies, affecting many aspects of clinical care and requiring standardisation of practice and training., Objective: This study aimed to provide guidance on the standardisation of its practice and training in Barrett's oesophagus, biliary strictures, colorectal lesions and inflammatory bowel diseases., Methods: Initial statements were developed by five group leaders, based on the available clinical evidence. These statements were then voted and edited by the 26 participants, using a modified Delphi approach. After two rounds of votes, statements were validated if the threshold of agreement was higher than 75%., Results: Twenty-six experts participated and, among a total of 77 statements, 61 were adopted (79%) and 16 were rejected (21%). The adoption of each statement was justified by the grade of evidence., Conclusion: pCLE should be used to enhance the diagnostic arsenal in the evaluation of these indications, by providing microscopic information which improves the diagnostic performance of the physician. In order actually to implement this technology in the clinical routine, and to ensure good practice, standardised initial and continuing institutional training programmes should be established.

Background. The SpyGlass Direct Visualization System (Boston Scientific, Natick, MA) is routinely used during single operator choledochoscopy (SOC) to identify biliary lesions or strictures with a diagnostic accuracy up to 88%. The objective of this study was to determine the interobserver agreement (IOA) of modified scoring criteria for diagnosing biliary lesions/strictures. Methods. 27 SPY SOC video clips were reviewed and scored by 9 interventional endoscopists based on published criteria that included the presence and severity of surface structure, vasculature visualization, lesions, and findings. Results. Overall IOA was "slight" for all variables. The K statistics are as follows: surface (K = 0.12, SE = 0.02); vessels (K = 0.14, SE = 0.02); lesions (K = 0.11, SE = 0.02); findings (K = 0.08, SE = 0.03); and final diagnosis (K = 0.08, SE = 0.02). The IOA for "findings" and "final diagnosis" was also only "slight." The final diagnosis was malignant (11), benign (11), and indeterminate (5). Conclusion. IOA using the modified criteria of SOC images was slight to almost poor. The average accuracy was less than 50%. These findings reaffirm that imaging criteria for benign and malignant biliary pathology need to be formally established and validated.

Colorectal cancer screening has been shown to help prevent cancer-related death. Concerns about suboptimal adherence to conventional colonoscopy has led to the search for alternative screening modalities. Computed tomography colono-graphy (CTC) is a highly sensitive and minimally invasive alternative modality. The American College of Radiology has established a standardized reporting system for CTC. The advantages of CTC include complete colonic examination and extraluminal imaging in a single breath hold time. Lack of sensitivity in the evaluation of flat lesions and radiation exposure are the main concerns with this modality. Although the usefulness of CTC has been demonstrated in academic centers, larger studies in community settings are needed to facilitate its adoption by healthcare services.

Pain resulting from chronic pancreatitis is often debilitating and difficult to manage. Many approaches have been used to treat these patients, including narcotic analgesia, antidepressants, pancreatic enzymes, octreotide, denervation procedures, such as celiac plexus block, and various palliative, decompression, or drainage procedures. Many of these procedures can be performed endoscopically, while others require a more invasive, surgical approach. The effectiveness of these therapies is not only highly variable but also often controversial. This review will discuss the endoscopic options for pain management in patients with chronic pancreatitis and their utility in treating this difficult disease.

Context: Pancreatic stents may be placed during therapeutic ERCP for a variety of indications. One such indication is to prophylax against the development of pancreatitis following sphincterotomy of the minor papilla in patients with recurrent acute pancreatitis and pancreas divisum. Increasingly, endoscopists that perform pancreatic ERCP are placing small caliber (3 Fr), unflanged, single pigtail stents into the long axis of the pancreatic duct with the expectation that these stents will only stay in place for a few days and the majority will pass spontaneously on their own without the need for follow-up endoscopic retrieval. As such, these stents are generally regarded as safer and associated with a lower rare of complication than larger (5 and 7 Fr), double flanged pancreatic stents., Case Report: We present the case of a 3 Fr stent that migrated proximally into the dorsal duct in a patient with recurrent pancreatitis and pancreas divisum. Due to the small size of the patient's dorsal duct, it was difficult to pass appliances alongside the stent to facilitate retrieval and a variety of appliances were used before success was achieved., Discussion: The medical literature contains series of proximally migrated larger caliber flanged, pancreatic stents but proximal migration of small caliber, unflanged, pigtail stents has not yet been reported. As the use of these small stents increases, we feel that it is important to highlight the potential for this complication and discuss how we successfully treated our patient.

Most patients with pancreatic cancer present with a mass on radiologic studies, however, not every pancreatic mass is cancer. Since radiological studies alone are insufficient to establish the diagnosis of a pancreatic mass and patient management depends on a definitive diagnosis; confirmatory cytology or histology is usually required. As a minimally invasive procedure, EUS and EUS FNA avoid the risk of cutaneous or peritoneal contamination that may occur with CT or US-guided investigations and is less invasive than surgical interventions. As a result, EUS FNA of pancreatic masses is becoming the standard for obtaining cytological diagnosis. This chapter presents an EUS-based diagnostic algorithm for the evaluation of pancreatic lesions and is based upon a review of the pertinent literature in the field of pancreatic endosonography that has been the most influential in helping to guide this evolving field. Realizing there is much overlap among the EUS characteristics of various pancreatic lesions, for the sake of simplicity we have structured our discussion in broad terms of solid versus cystic lesions and discuss various pancreatic lesions within this framework. The additional contributors to this round table discussion have been asked to provide a more dedicated, focused discussion of the various subcategories of pancreatic lesions in greater detail than we could hope to achieve here. We provide this final contribution to the round table as a means of bringing the discussion back to the big picture of pancreatic lesions, rather than trying to hone in on the fine details of any one subclass.

Background & Aims: Mediastinal granulomas due to histoplasmosis can cause dysphagia and can be difficult to diagnose. The aim of this study was to describe the endoscopic ultrasonography (EUS) findings of suspected mediastinal granulomas., Methods: Eleven patients with dysphagia were referred for EUS because endoscopy showed a midesophageal submucosal mass or stricture., Results: All patients had similar EUS findings of a large mass of matted, posterior mediastinal lymph nodes that were adherent to a focally thickened esophageal wall. The cause of the mediastinal granulomas was believed to be histoplasmosis because 3 of the patients had positive complement fixation titers of 1:32, 1 of whom had a surgical resection showing a caseating granuloma. The diagnosis of histoplasmosis mediastinal granulomas was also supported by the findings of lymph node calcification on EUS in 7 patients, the presence or development of midesophageal traction diverticula in 5 patients, and clinical improvement after oral antifungal drug therapy in 7 patients. No patient developed evidence of malignancy during a mean follow-up period of 20.5 months., Conclusions: Based on characteristic EUS findings, mediastinal granulomas are believed to occur in patients with dysphagia who have a midesophageal submucosal mass or stricture on endoscopy and who live in a highly endemic area for histoplasmosis.