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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.

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.

Technological advances in the field of endoscopic ultrasound (EUS) have emerged, especially in the past decade, that have rapidly expanded the therapeutic potential of EUS, largely through the innovations of accessory technology that could not have happened without innovative changes to echoendoscopes. As interventional EUS continues to evolve, further expansion into previously uncharted areas will most certainly happen.

Background and Aims Diagnosis of pancreatic cystic lesions (PCLs) remains challenging. EUS with FNA is limited by sampling error and nondiagnostic cytology. Needle-based confocal laser endomicroscopy (nCLE) performed during EUS can be used to improve diagnostic yield via FNA by providing in vivo histology of PCLs. However, the interobserver agreement (IOA) of nCLE of PCLs has yet to be studied. Methods Fifteen deidentified nCLE video clips of PCLs were sent to 6 interventional endoscopists at 5 institutions. Six variables were assessed for IOA: presence or absence of (1) vessels, (2) villi, (3) dark clumps, (4) reticular pattern, (5) acinar cells pattern, and (6) debris. PCL interpretation was categorized as mucinous, serous, pseudocyst, malignant, or indeterminate and final diagnosis as benign, malignant, or indeterminate. Results IOA ranged from "poor" to "fair." The K statistics were –.04 (SE = .05) for vessels, .16 (SE = .07) for villi, .22 (SE = .06) for dark clumps, .13 (SE = .06) for reticular pattern, .14 (SE = .06) for acinar cells pattern, .06 (SE = .06) for debris, .15 (SE = .03) for interpretation, .13 (SE = .05) for final diagnosis, and .19 (SE = .05) for image quality. The final diagnosis was malignant (10), benign (13), and indeterminate (2). The mean accuracy of the observers was 46%, with the lowest being 20% and highest being 67%. Conclusions The IOA and accuracy for PCL diagnosis were low. The results of this study support the need to identify and validate imaging criteria to determine whether nCLE has diagnostic value for pancreatic pathology. (Clinical trial registration number: NCT02166086.)

SUMMARY Volumetric laser endomicroscopy (VLE) uses optical coherence tomography (OCT) for real-time, microscopic cross-sectional imaging. A US-based multi-center registry was constructed to prospectively collect data on patients undergoing upper endoscopy during which a VLE scan was performed. The objective of this registry was to determine usage patterns of VLE in clinical practice and to estimate quantitative and qualitative performance metrics as they are applied to Barrett's esophagus (BE) management. All procedures utilized the NvisionVLE Imaging System (NinePoint Medical, Bedford, MA) which was used by investigators to identify the tissue types present, along with focal areas of concern. Following the VLE procedure, investigators were asked to answer six key questions regarding how VLE impacted each case. Statistical analyses including neoplasia diagnostic yield improvement using VLE was performed. One thousand patients were enrolled across 18 US trial sites from August 2014 through April 2016. In patients with previously diagnosed or suspected BE (894/1000), investigators used VLE and identified areas of concern not seen on white light endoscopy (WLE) in 59% of the procedures. VLE imaging also guided tissue acquisition and treatment in 71% and 54% of procedures, respectively. VLE as an adjunct modality improved the neoplasia diagnostic yield by 55% beyond the standard of care practice. In patients with no prior history of therapy, and without visual findings from other technologies, VLE-guided tissue acquisition increased neoplasia detection over random biopsies by 700%. Registry investigators reported that VLE improved the BE management process when used as an adjunct tissue acquisition and treatment guidance tool. The ability of VLE to image large segments of the esophagus with microscopic cross-sectional detail may provide additional benefits including higher yield biopsies and more efficient tissue acquisition. Clinicaltrials.gov NCT02215291

Background and Aim Current diagnostic modalities for indeterminate biliary strictures offer low accuracy. Probe-based confocal laser endomicroscopy (pCLE) permits microscopic assessment of mucosal structures by obtaining real-time high-resolution images of the mucosal layers of the gastrointestinal tract. Previously, an interobserver study demonstrated poor to fair agreement even among experienced confocal endomicroscopy operators. Our objective was to assess interobserver agreement and diagnostic accuracy upon completion of a pCLE training session. Methods Forty de-identified pCLE video clips of indeterminate biliary strictures were sent to five endoscopists at four tertiary care centers for scoring. Observers subsequently attended a teaching session by an expert pCLE user that included 20 training clips and rescored the same pCLE video clips, which were randomized and renumbered. Results Pre-training interobserver agreement for all observers was ‘fair’ (Κ: 0.31, P-value

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.

Endoscopic ultrasound (EUS) is probably the most challenging endoscopic technique to learn because it not only requires comprehension of luminal endoscopy, but also compels the endoscopist to be able to understand ultrasound and recognize three-dimensional anatomy. As a result, the learning curve for EUS is steep and requires a large volume of wide-ranging cases to successfully accomplish training. Endoscopic simulators have the potential to play a unique role in EUS training based on the ability to simulate visual and tactile experiences that one would encounter during actual EUS procedures. Over the past few decades a variety of EUS training simulators have been developed to facilitate EUS training. This review will discuss current simulators available and their potential impact on EUS training.

BACKGROUND AND STUDY AIMS Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is now performed routinely in many advanced endoscopy centers and has enhanced the ability to diagnose pancreatic masses. However, there is uncertainty about which needle size is optimal for EUS-FNA of pancreatic masses. We aimed to evaluate the performance of the 22-gauge and 25-gauge needles in obtaining cytologic diagnosis of pancreatic masses. METHODS All cases that were referred for EUS-FNA for pancreatic masses between February 2001 and June 2007 were reviewed, and patients who underwent EUS-FNA using the 22-gauge and 25-gauge needle system were identified. In patients who underwent surgery, operative histopathological findings were compared with the cytopathological findings from EUS-FNA. RESULTS A total of 842 patients with pancreatic masses detected on computed tomography (CT) and/or magnetic resonance imaging (MRI) and confirmed by EUS underwent EUS-FNA with the 22-gauge needle (n = 540) or the 25-gauge needle (n = 302). Results of EUS-FNA cytology findings were compared with the gold standard of surgical histopathological findings or long-term clinical follow-up. The sensitivity, specificity, PPV, and NPV of FNA were respectively 84%, 100%, 100%, and 73% [corrected] for the 22-gauge needle compared with 92%, 97%, 98%, and 87%, [corrected] respectively for the 25-gauge needle. No complications were noted in the 25-gauge needle group, compared with pancreatitis in 2% of the 22-gauge needle group. CONCLUSIONS This retrospective comparative study shows that EUS-FNA with a 25-gauge needle system is a safe and reliable method for tissue sampling in pancreatic masses. The system is more sensitive and has a slightly [corrected] higher NPV than the standard 22-gauge needle. Our study suggests that perhaps the smaller caliber FNA needle causes less trauma during EUS-FNA and hence less complications. Further studies including randomized trials are needed.

Background:Endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA) is a minimally invasive alternative technique for mediastinal staging of non-small cell lung cancer. A metaanalysis was performed to estimate the diagnostic accuracy of EUS-FNA for staging mediastinal lymph nodes (N2/N3 disease) in patients with lung cancer. Methods:Relevant studies were identified using Medline (1966 to November 2005), CINAHL, and citation indexing. Included studies used histology or adequate clinical follow-up (> 6 months) as the "gold standard," and provided sufficient data for calculating sensitivity and specificity. Summary receiver operating characteristic curves metaanalysis was performed to estimate the pooled sensitivity and specificity. Results:In 18 eligible studies, EUS-FNA identified 83% of patients (95% confidence interval [CI], 78 to 87%) with positive mediastinal lymph nodes (pooled sensitivity) and 97% of patients (95% CI, 96 to 98%) with negative mediastinal lymph nodes (pooled specificity). In eight studies that were limited to patients who had abnormal mediastinal lymph nodes seen on CT scans, the sensitivity was 90% (95% CI, 84 to 94%) and the specificity was 97% (95% CI, 95 to 98%). In patients without abnormal mediastinal lymph nodes seen on CT scans (four studies), the pooled sensitivity was 58% (95% CI, 39 to 75%). Minor complications were reported in 10 cases (0.8%). There were no major complications. Conclusions:EUS-FNA is a safe modality for the invasive staging of lung cancer that is highly sensitive when used to confirm metastasis to mediastinal lymph nodes seen on CT scans. In addition, among lung cancer patients with normal mediastinal adenopathy seen on CT scans, despite lower sensitivity, it has the potential to prevent unnecessary surgery in a large proportion of cases missed by CT scanning.

The preoperative evaluation of oesophageal adenocarcinoma involves endoscopic ultrasound (EUS), computed tomography (CT), and positron emission tomography (PET). With routine Barrett's oesophagus surveillance, superficial cancers are often identified. EUS, CT and PET have a limited role in the staging of superficial tumours. Standard EUS has limited accuracy, but high frequency ultrasound miniprobes are valuable for assessing tumour stage in superficial tumours. However, the best method for determining depth of invasion, and thereby stage of disease, is endoscopic mucosal resection. In contrast, in advanced oesophageal cancers, a multi-modality approach is crucial. Accurate tumour staging is very important since the treatment of advanced cancers involves a combination of chemotherapy, radiation, and surgery. EUS is very useful for staging of the tumour and nodes. High frequency ultrasound miniprobes provide the ability to perform staging when the lesion is obstructing the oesophageal lumen. CT and PET provide valuable information regarding node and metastasis staging.

Metastatic lesions of the pancreas are a rare but important cause of focal pancreatic lesions. The purpose of this study is to describe the EUS features, cytologic diagnoses, and clinical impact of a cohort of patients with pancreatic metastases diagnosed by EUS-guided FNA (EUS-FNA).Over a 6-year period, in a retrospective, multicenter study, patients had the diagnosis of pancreatic metastases confirmed with EUS-FNA. All examinations were performed by one of 5 experienced endosonographers. The EUS and the clinical findings of pancreatic metastases were compared with those of a cohort with primary pancreatic malignancy.Thirty-seven patients with possible metastases were identified, and 13 were excluded because of diagnostic uncertainty. The remaining 24 underwent EUS-FNA (mean passes 4.1) of a pancreatic mass without complications. Diagnoses included metastases from primary kidney (10), skin (6), lung (4), colon (2), liver (1), and stomach (1) cancer. In 4 (17%), 16 (67%), and 24 (100%) patients, EUS-FNA provided the initial diagnosis of malignancy, tumor recurrence, and pancreatic metastases, respectively. Four (17%) metastases initially were discovered by EUS after negative (n = 3) or inconclusive (n = 1) CT scans. Compared with primary cancer, pancreatic metastases were more likely to have well-defined margins (46% vs. 4%) compared with irregular (94% vs. 54%; p0.0001) margins. No statistically significant difference between the two populations was noted for tumor size, echogenicity, consistency, location, lesion number, or number of FNA passes performed.Pancreatic metastases are an important cause of focal pancreatic lesions and may occasionally be discovered during EUS examination after previously negative or inconclusive CT. Use of immunocytochemistry, when available, may help to confirm a suspected diagnosis. These lesions are more likely to have well-defined EUS margins compared with primary pancreatic cancer.

Background: The aim of this study was to evaluate the degree of agreement among endosonographers for EUS diagnosis of neoplastic versus non-neoplastic pancreatic cystic lesions and the specific type of cystic lesion. Methods: Videotapes of EUS procedures from 31 consecutive cases of a range of histopathologically proven lesions, including mucinous cystic neoplasm, serous cystadenoma, neuroendocrine tumor, intraductal papillary mucinous tumor, and pseudocyst, were used to make a study videotape, which was reviewed by 8 experienced endosonographers. The reviewers, blinded to clinical and surgical histopathology results, reviewed each case for the presence or absence of the following features: abnormality of pancreatic duct and parenchyma, margins, solid component, debris, and septations. They were asked to identify each lesion as neoplastic or non-neoplastic and to give a specific diagnosis for each lesion. Results: There was fair agreement between endosonographers for diagnosis of neoplastic versus non-neoplastic lesions (κ = 0.24). Agreement for individual types of lesions was moderately good for serous cystadenomas (κ = 0.46) but fair for the remainder. Agreement was moderately good for presence or absence of solid component (κ = 0.43); fair for presence or absence of abnormal pancreatic duct (κ = 0.29), debris (κ = 0.21), and septations (κ = 0.30); and slight for presence or absence of margins (κ = 0.01) and abnormal pancreatic parenchyma (κ = 0.01). Accuracy rates of EUS for the diagnosis of neoplastic versus non-neoplastic lesions ranged from 40% to 93%. Conclusions: There is little more than chance interobserver agreement among experienced endosonographers for diagnosis of neoplastic versus non-neoplastic, specific type, and EUS features of pancreatic cystic lesions. (Gastrointest Endosc 2003;58:59-64.)

From the data that are currently available, it appears that EUS can help to reliably distinguish between the majority of benign and neoplastic cystic lesions. In equivocal cases, or cases where a high suspicion for malignancy exists, the use of EUS-guided FNA for obtaining cytology and cystic fluid for analysis of various tumor markers, gives the best diagnostic yield. Occasionally, despite a complete evaluation of a cystic mass, the cyst type may not be determined. The decision regarding further management of these lesions should be based on a combination of factors including symptoms, cyst size, EUS morphology and the patient's overall medical condition. In the case of symptomatic, large, or suspicious lesions where the patient is a good surgical candidate, surgical resection should be performed. However, it becomes more difficult in the case of asymptomatic, small cystic lesions where the patient is not an optimal surgical candidate. In the latter scenario, applying EUS criteria for follow-up of small pancreatic cystic lesions as reported by Ikeda et al can help in the decision-making process. In this study, Ikeda et al reported on 31 patients with pancreatic cystic lesions of unknown etiology that were followed-up with semi-annual EUS exams over a 3-year period. In 87.1% of these lesions, the size was less than 2 cm. Their criteria included 1) a clear thin wall, 2) smooth contour, 3) round or oval shape, 4) no septum or nodules, 5) asymptomatic clinical presentation, and 6) no findings of chronic pancreatitis. The cystic lesions remained stable in 30/31 patients, and only one lesion increased in size. This lesion was resected and was found to be a retention cyst. We are optimistic that the role of EUS in the management of cystic neoplasms will continue to evolve and expand as future studies evaluate the clinical utility of imaging modalities for the optimal practice algorithm for managing these neoplasms.

Background: Mediastinal masses represent a diagnostic challenge because of their proximity to numerous critical structures, difficulty of access for tissue sampling, and myriad potential pathologic etiologies. A large, single-center experience with EUS-guided fine-needle aspiration (EUS-FNA) in the diagnosis of non-lung cancer-related mediastinal masses is presented. Methods: An EUS database was reviewed and all cases of mediastinal mass or lymphadenopathy encountered between 1994 and 1999 were included. Final diagnoses were determined by EUS-FNA cytology and clinical follow-up. Results: Forty-nine patients were identified (27 women, 22 men; mean age 58.1 years, range 30-89 years). A malignant process was diagnosed in 22 cases (45%) and a benign process in 24 (49%). The EUS-FNA specimen was nondiagnostic in 3 cases (6%). An accurate diagnosis was made in 46 of the 49 patients (94%). No complication was noted. Conclusions: EUS-FNA is a minimally invasive technique that facilitates detection and tissue sampling of mediastinal masses. It is a safe procedure that can be performed with the patient under conscious sedation in an outpatient setting. (Gastrointest Endosc 2002;56:397-401.)

Background: EUS-guided fine needle aspiration (EUS-FNA) has significantly expanded the diagnostic capability of GI EUS. FNA technology can also be helpful in the diagnosis of non-GI disorders. The role of EUS-guided FNA in the diagnosis of mediastinal lymphadenopathy of unknown etiology has not been described. The aim of this study was to evaluate the diagnostic accuracy and impact on subsequent evaluation and therapy of EUS-FNA in mediastinal lymphadenopathy of unknown cause. Methods: Sixty-two patients (40 men, 22 woman; mean age 56 years, range 16-91 years) with mediastinal lymphadenopathy of unknown etiology underwent EUS-FNA at 6 tertiary referral centers. Presenting symptoms included the following: dysphagia, 6 patients; night sweats, 14; cough, 8; chest pain, 10; odynophagia, 10; fever, 6; weight loss, 8; and asymptomatic/abnormal radiograph, 12. A final diagnosis by EUS-FNA, surgery, autopsy, or long-term follow-up was available for all patients. EUS-FNA results were classified under 3 disease categories: (1) benign/infectious; (2) malignant pulmonary; and (3) malignant mediastinal (e.g., lymphoma, metastatic malignancy). Four EUS features were used as criteria for lymph node metastases: size greater than 1 cm, round shape, sharp border, and homogeneous/hypoechoic echo pattern. Results: Final diagnoses included benign/infectious lymph nodes, 26; malignant pulmonary, 24; and malignant mediastinal, 12. EUS-FNA established a tissue diagnosis in 56 of 62 patients (90%). EUS criteria for malignant lymph nodes were more frequently present in malignant pulmonary (mean 2.6 features) and malignant mediastinal (mean 2.8) than benign/infectious (mean 1.9) lymph nodes. EUS results influenced subsequent evaluation in 87% and therapy in 87% of patients. There was no complication of EUS-FNA. Conclusions: EUS-FNA in patients with mediastinal lymphadenopathy is safe and guides subsequent therapy in the great majority of cases. Transesophageal EUS-FNA of mediastinal lymph nodes provides minimally invasive tissue sampling, obviating the need for mediastinoscopy or bronchoscopy. (Gastrointest Endosc 2002;55:863-9.)

Background: Neuroendocrine tumors of the pancreas are rare. Various imaging modalities are employed preoperatively to assist in the diagnosis and localization of these tumors. However, surgeons usually have to perform manual palpation of the pancreas and peripancreatic tissues in addition to intraoperative ultrasound to localize these tumors, especially when they are small and difficult to visualize. Aim: The purpose of this ongoing study is to demonstrate the role and safety of EUS-guided fine needle tattooing (FNT) of these tumors so they can be identified more easily at the time of surgery. Methods: Two patients with clinical and biochemical evidence of neuroendocrine tumors who failed localization with routine imaging modalities were referred for EUS. After localizing and staging each tumor, EUS-guided FNA was performed for tissue diagnosis followed by the injection of sterilized India ink within the lesions. The injection needle was initially purged with the India ink outside the lesion so as not to inject air, which may attenuate visualization of the tumor. No antibiotics were given before or after the procedure. Results:One patient with insulinoma (48 y/o, F) underwent EUS-FNT. At laparotomy the tattooed tumor was readily seen. Manual palpation and intraoperative ultrasound further proved it. No India ink was seen outside the tumor. The resected specimen confirmed that the tattooed area contained the insulinoma. The second patient (76 y/o. M) was diagnosed with a carcinoid tumor located in the peripancreatic region near the head of the pancreas. This patient also underwent EUS-FNT but refused surgery. Both patients did well post-procedure with no evidence of infectious complications. Conclusion: EUS-FNT is a promising new technique that may aid in the preoperative localization of neuroendocrine tumors and perhaps be cost effective. It might be of great importance in the era of laparoscopic enucleation of neuroendocrine tumors that has recently been described. A multi center study is warranted for further evaluation.

Supplemental Digital Content is available in the text, 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. 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.

Background: Accessory spleen is a common congenital anomaly. There are currently no endoscopic ultrasound (EUS) criteria for the diagnosis or differentiation of this benign splenic anomaly from pathologic disorders including neoplasms. The purpose of this study was to characterize EUS features and develop criteria for the diagnosis of accessory spleen. Methods: Ten patients undergoing EUS were found to have a possible pancreatic tail or perisplenic mass later confirmed by CT to be either an accessory spleen or a prominent lobule of the spleen. EUS criteria assessed included size, shape, location, echo texture, echo density and border demarcation. Results: Ten patients (mean age 58 years) were evaluated. Indications for EUS were evaluation of pancreaticobiliary disease in 9 patients and a gastric submucosal mass in 1 patient. Eight patients had an accessory spleen and 2 had a lobulated spleen. The mean diameter of these lesions as seen on EUS was 2.70 × 3.12 cm. Nine were round and 1 was oval. Because all were located inferolateral to the pancreatic tail and medial to the spleen, 5 of 10 were initially thought to be pancreatic masses. All of these lesions had a sharp and regular outer margin and homogenous echo texture, 4 were hypoechoic and 6 hyperechoic. There were no specific EUS features identified that differentiated splenic lobulations from accessory spleen. Conclusions: Accessory spleen and splenic lobulation can be misinterpreted as neoplasm by EUS. Although homogenous, they can be hyperechoic or hypoechoic. Their sharp and regular outer margin and anatomic location may help to avoid misdiagnosis. Furthermore, computed tomography may be helpful in confirming their presence.

The prognosis of patients with rectal cancer correlates with the stage of the disease at diagnosis. The treatment of rectal cancer involves the use of neoadjuvant and postoperative chemoradiotherapy. Patient selection for neoadjuvant therapy relies on the use of computed tomography and endorectal ultrasound staging. Overall staging is determined by the depth of tumor penetration (generally referred to as T stage), the presence or absence of nodal involvement (N stage), and distant metastases (M stage). Endoscopic ultrasound (EUS) is the only staging modality that provides direct visualization of the normal 5 layers of the rectal wall. Furthermore, perirectal lymphadenopathy can be clearly imaged. These attributes make EUS an important imaging modality for the preoperative staging of rectal cancer. This article describes the EUS techniques for performing accurate preoperative staging of rectal cancer and discuss its role in the management of rectal carcinoma.

Background: Current methods for staging pancreatic cancer can be inaccurate, invasive, and expensive. Endoscopic ultrasound (EUS) is reported to be highly accurate for local staging of gastrointestinal tumors including pancreatic cancer. The aim of this study was to assess the utility of EUS and CT for staging pancreatic cancer by comparing staging accuracies in surgical patients and evaluating the potential impact of EUS staging and training. Methods: This was a preoperative comparison of the diagnostic operating characteristics of these procedures in a referral-based academic medical center. Data were collected on 151 consecutive patients referred with confirmed pancreatic cancer between April 1990 and November 1996. All patients had preoperative CT and EUS performed for staging. In patients undergoing surgery, the surgical staging and/or findings were used to confirm EUS and CT staging. Results: Eighty-one (60%) of 151 patients underwent surgery and made up the study subset. In these 81 patients, surgical exploration provided a final T staging in 93% (75 of 81), N staging in 88% (71 of 81) and data on vascular invasion in 93% (75 of 81). In the surgical patient group, with surgical correlation, EUS accuracy for T staging was as follows: T1 92%, T2 85%, T3 93%, and for N staging was: N0 72%, and N1 72%. CT accuracy for T staging was as follows: T1 65%, T2 67%, T3 38%, and for N staging was as follows: N0 52% and N1 100%. CT failed to detect a mass in 26% of patients with a confirmed tumor at surgery. Overall accuracy for T and N staging was 85% and 72% for EUS and 30% and 55% for CT, respectively. The ability to accurately predict vascular invasion was 93% for EUS and 62% for CT (p < 0.001). EUS was 93% accurate for predicting local resectability versus 60% for CT (p < 0.001). Last, the data were divided into two groups for the senior endosonographer’s experience: procedures performed between 1990 and 1992 (98 cases) and 1993 and 1994 (53 cases). This analysis revealed that 7 of 9 instances of misstaging (78%) occurred in the earlier group, during the learning phase for EUS. Conclusions: EUS is more accurate than CT for staging pancreatic malignancies, including predicting vascular invasion and local resectability. EUS staging was significantly better than CT for T1, T2, and T3 tumors. EUS staging accuracy improved after 100 cases, thus suggesting a correlation between the accuracy of EUS staging and the number of procedures performed. (Gastrointest Endosc 1999;50:786-91.)

a b s t r a c t Background: Single operator choledochoscopy is a platform used to assist in the confirmation of diagnosis of biliary lesions. However, there are little data regarding the interobserver agreement of imaging inter- pretation. Our objective was to assess the interobserver agreement in single operator choledochoscopy interpretation. Methods: 38 De-identified SPY Choledochoscopy video clips were sent to 7 interventional endoscopists. They were asked to score the videos on presence of four criteria selected by the investigators: growth, stricture, hyperplasia, and ulceration. Observers also chose a final diagnosis from the categories of cancer, hyperplasia, inflammation, or normal. Kappa scores were calculated for the scoring of the four criteria and for the selection of the final diagnosis. Results: The overall interobserver agreement was fair in scoring for the presence of a growth (K = 0.28, SE 0.035) and stricture (K = 0.32, SE 0.035). Scoring for ulceration was slight to fair (K = 0.17, SE 0.035). There was only slight agreement for the presence of hyperplasia (K = 0.11, SE 0.035); and presumed final diagnosis based on imaging (K = 0.18, SE 0.022). Conclusion: The results of this study support the need for an effort to identify and validate cholangioscopy imaging criteria for biliary pathology. This may assist in improving the reliability of the diagnostic value of cholangioscopy as its use becomes more widespread.

Background and study aims Complete examination of the biliary tree and pancreatic duct may be difficult or unsuccessful using conventional imaging instruments. The purpose of this study was to evaluate the cannulation success rate, clinical utility, and safety of a new catheter-based ultrasound probe (CBUSP) used in the biliary tree and pancreas. Patients and methods The probes used in this study are manufactured by Microvasive (Watertown, MA, U.S.A.) and were 6.2 Fr in diameter, operated at 12.5 MHz. Thirty-six patients (11 with malignant bile-duct strictures, 12 with benign bile-duct strictures, two with bile duct stones, three with pancreatic duct strictures, one with a pancreatic cyst, one with pancreas divisum, three with sphincter of Oddi dysfunction, and three normal) underwent examination with a CBUSP. Results Cannulation was successful in all 36 patients. The hepatic artery and portal vein could be visualized with the probe in the proximal bile duct in 81% and 94% of the cases, respectively. The portal vein could not be adequately visualized in any patients when the probe was in the distal bile duct. The mean thickness of the normal bile duct wall was 0.17 cm, and the mean wall thicknesses proximal to a benign and malignant stricture were 0.16 and 0.17 cm, respectively. The mean thicknesses of benign and malignant biliary strictures were 0.32 cm and 0.31 cm, respectively (not significant). Eight of 12 benign biliary strictures (67%) and five of 11 malignant strictures (45%) were symmetrical. However, no obvious differences could be identified between benign and malignant biliary strictures. There were no catheter related complications. Conclusions Further catheter modifications are needed, but it appears to be feasible to assess vascular invasion in cholangiocarcinoma and to characterize biliary strictures in a way that may be able to influence therapy options in some patients. The currently available CBUSP cannot distinguish between benign and malignant strictures. However, with technical modifications, this may be possible in the future. The clinical usefulness of CBUSP in the pancreas awaits further investigation, but pancreatic imaging is feasible.

Background Tissue sampling of renal lesions is traditionally performed with percutaneous US or CT guidance. To date, only 3 known cases of EUS-guided FNA (EUS-FNA) of a renal mass have been reported. Objective To describe a multicenter experience with the indications, yield, and complications from attempted EUS-FNA of a kidney mass. Design Retrospective case series. Setting Six tertiary referral hospitals in the United States. Patients Consecutive subjects undergoing attempted EUS-FNA of a kidney mass. Endosonographers at 15 other teaching hospitals were contacted regarding EUS findings and follow-up of any EUS-guided renal biopsies previously attempted or considered at that institution. Interventions EUS-FNA of a kidney mass. Main Outcome Measurements Biopsy indications, yield, diagnosis, and complications. Results Fifteen procedures in 15 patients (9 men; median age 67 years) were performed at 6 (37%) of 16 hospitals (Indiana University plus 15 other hospitals). Kidney masses (median diameter 32 mm; range 11-60 mm) were located in the upper (n = 12) and lower (n = 3) poles of the left (n = 10) and right (n = 5) kidneys, respectively. Initial mass detection was by previous imaging in 13 (87%) patients or by EUS in 2 (13%) patients. Results of EUS-FNA (median 3 passes; range 2-4 passes) in 13 (87%) procedures were diagnostic of (n = 7) or highly suspicious for (n = 1) renal cell carcinoma (RCC), atypical cells (n = 2), oncocytoma (n = 1), benign cyst (n = 1), and nondiagnostic (n = 1). No complications were encountered. Surgical resection confirmed RCC in 7 patients in whom preoperative EUS-FNA demonstrated RCC (n = 5) or oncocytoma (n = 1) or was not performed (n = 1). Limitations Retrospective series, small number of patients. Conclusions EUS-FNA of renal masses is rarely performed at the U.S. teaching hospitals surveyed. This technique appears safe and feasible and should be considered when results would affect patient management.

Background EUS plays an important role in the preoperative staging of esophageal cancer. Recent data have called into question the staging accuracy of EUS, particularly in patients with early disease. Objective Our goals were to assess our institution's EUS staging accuracy by experienced endosonographers in a contemporary cohort of patients encompassing a wide range of disease stages and to assess staging accuracy after dilation of malignant strictures. Design Retrospective data review. Setting Single tertiary care center. Patients and Interventions A total of 42 patients with esophageal cancer undergoing preoperative EUS staging without neoadjuvant chemoradiotherapy between December 1999 and December 2004 were evaluated. Main Outcome Measurements EUS T and N stage sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. Results EUS accurately predicted T stage in 76% of cases and N stage in 89% of cases. Staging accuracy for T3 versus T1 and T2 disease and for N0 versus N1 disease was not significantly different. In 11 cases, malignant strictures required dilation, with 6 tumors being passable post dilation. Post dilation, T staging accuracy was 80% in impassable tumors and 100% in passable tumors, and N staging accuracy was 100% in the passable tumors. Limitations Relatively small number of patients. Conclusions EUS accurately predicts T and N stage in patients with a range of disease stages. EUS provides good staging accuracy after dilation of malignant strictures regardless of whether full tumor traversal post dilation is possible.

EUS is a promising modality for pancreatic-cancer screening in high-risk persons, including familial pancreatic-cancer (FPC) kindreds.To assess interobserver agreement for interpretation of EUS in persons at high risk for pancreatic cancer.Seventeen expert endosonographers blinded to patients' clinical history rated a "training set" of pancreatic EUS video clips for the presence of a normal examination, masses, cysts, and features of chronic pancreatitis. Clips included high-risk persons and controls (normal and various pancreatic diseases). The endosonographers then participated in a workshop on EUS findings in high-risk persons and drafted a consensus statement. Three months later, they blindly rated a "test set" composed of the same video clips.Interobserver agreement at baseline (training set) and after a consensus process (test set).For the training set, interobserver agreement was good (kappaor=0.4) for the presence of cysts and was fair to poor for all other rated EUS features and diagnosis of normal. There was no overall improvement in the test set. In both the training and test sets, agreement was worse for clips from FPC kindreds (kappaor=0.4 for cysts and0.4 for all other features) than for controls (kappaor=0.4 for normal, cysts, masses, echogenic strands, and lobularity).Video clips were not of identical image quality and duration as a clinical EUS examination.There was fair to poor interobserver agreement for the interpretation of pancreatic EUS video clips from members of FPC kindreds. Agreement was not improved by a consensus process.