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Background and Aims: Several studies have compared EUS-guided FNA with fine-needle biopsy (FNB), but none have proven superiority. We performed a multicenter randomized controlled trial to compare the performance of a commonly used 25-gauge FNA needle with a newly designed 20-gauge FNB needle., Methods: Consecutive patients with a solid lesion were randomized in this international multicenter study between a 25-gauge FNA (EchoTip Ultra) or a 20-gauge FNB needle (ProCore). The primary endpoint was diagnostic accuracy for malignancy and the Bethesda classification (non-diagnostic, benign, atypical, malignant). Technical success, safety, and sample quality were also assessed. Multivariable and supplementary analyses were performed to adjust for confounders., Results: A total of 608 patients were allocated to FNA (n = 306) or FNB (n = 302); 312 pancreatic lesions (51%), 147 lymph nodes (24%), and 149 other lesions (25%). Technical success rate was 100% for the 25-gauge FNA and 99% for the 20-gauge FNB needle (P = .043), with no differences in adverse events. The 20-gauge FNB needle outperformed 25-gauge FNA in terms of histologic yield (77% vs 44%, P < .001), accuracy for malignancy (87% vs 78%, P = .002) and Bethesda classification (82% vs 72%, P = .002). This was robust when corrected for indication, lesion size, number of passes, and presence of an on-site pathologist (odds ratio, 3.53; 95% confidence interval, 1.55-8.56; P = .004), and did not differ among centers (P = .836)., Conclusion: The 20-gauge FNB needle outperformed the 25-gauge FNA needle in terms of histologic yield and diagnostic accuracy. This benefit was irrespective of the indication and was consistent among participating centers, supporting the general applicability of our findings. (Clinical trial registration number: NCT02167074.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Pancreatic ductal adenocarcinoma (PDAC) is typically diagnosed at a late stage. Little is known about the incidental finding of early-stage PDAC. The aim of the current study was to determine the etiology of small solid pancreatic lesions (≤15 mm) to optimize clinical management., Methods: Inclusion criterion for the retrospective study analysis was the incidental finding of primarily undetermined small solid pancreatic lesions ≤15 mm in 394 asymptomatic patients. Final diagnoses were based on histology or cytology obtained by imaging-guided biopsy (and at least 12-month follow-up) and/or surgery. Contrast-enhanced US or contrast-enhanced EUS was performed in 219 patients., Results: The final diagnoses of 394 patients were as follows: 146 PDACs, 156 neuroendocrine tumors, 28 metastases into the pancreas from other primary sites, and 64 various other etiologies. Contrast-enhanced US allowed differential diagnosis of PDAC and non-PDAC in 189 of 219 patients (86%)., Conclusions: Approximately 40% of patients with small solid pancreatic lesions had very early stage PDAC. Approximately 60% of small solid pancreatic lesions ≤15 mm are not PDAC and, therefore, do not require radical surgery. Without preoperative diagnosis, an unacceptably large proportion of patients would be exposed to radical surgery with significant morbidity and mortality., (Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: The role of EUS with contrast agents can be expanded through the use of time-intensity curve (TIC) analysis and computer-aided interpretation., Objective: To validate the use of parameters derived from TIC analysis in an artificial neural network (ANN) classification model designed to diagnose pancreatic carcinoma (PC) and chronic pancreatitis (CP)., Setting: Prospective, multicenter, observational trial-endoscopy units from Romania, Denmark, Germany, and Spain., Patients: A total of 167 consecutive patients with PC or CP., Interventions: Contrast-enhanced harmonic EUS (CEH-EUS) and EUS-guided FNA (EUS-FNA), TIC analysis, and ANN processing., Main Outcome Measurements: Sensitivity, specificity, positive and negative predictive values (PPV, NPV) for EUS-FNA, CEH-EUS, and the ANN., Results: After excluding all of the recordings that did not meet the technical and procedural criteria, 112 cases of PC and 55 cases of CP were included. EUS-FNA was performed in 129 patients, and the diagnosis was confirmed by surgery (n = 15) or follow-up (n = 23) in the remaining cases. Its sensitivity and specificity were 84.82% and 100%, respectively, whereas the PPV and NPV were 100% and 76.63%, respectively. The sensitivity of real-time quantitative assessment of CEH-EUS was 87.5%, specificity 92.72%, PPV 96.07%, and NPV 78.46%. Peak enhancement, wash-in area under the curve, wash-in rate, and the wash-in perfusion index were significantly different between the groups. No significant differences were found between rise time, mean transit time, and time to peak. For the ANN, sensitivity was 94.64%, specificity 94.44%, PPV 97.24%, and NPV 89.47%., Limitations: Only PC and CP lesions were included., Conclusion: Parameters obtained through TIC analysis can differentiate between PC and CP cases and can be used in an automated computer-aided diagnostic system with good diagnostic results. (, Clinical Trial Registration Number: NCT01315548.)., (Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Diagnosis of pancreatic exocrine insufficiency (PEI) is hindered by methodological difficulties of pancreatic function tests. The probability of PEI in chronic pancreatitis (CP) increases as pancreatic fibrosis develops. Pancreatic fibrosis in CP may be quantified by EUS elastography., Objective: To evaluate whether EUS-elastography can predict PEI in patients with CP., Design: Prospective, observational study., Setting: Department of Gastroenterology, University Hospital of Santiago de Compostela, Spain., Patients: Patients diagnosed with CP based on EUS and magnetic resonance imaging and MRCP findings., Interventions: Diagnosis of PEI was based on the (13)C-mixed triglyceride breath test. EUS-elastography was performed with PENTAX echoendoscopes and Hitachi-Preirus US platform. Two areas were selected for elastographic evaluation: area A corresponds to the pancreatic parenchyma and area B to a soft peripancreatic reference area. The quotient B/A (strain ratio [SR]) was considered the elastographic result., Main Outcome Measurements: Pancreatic SR in CP patients with and without PEI., Results: A total of 115 patients with CP (mean age, 50.2 years, range, 21-81; 92 male) of different etiologies were included; 35 patients (30.4%) had PEI. Pancreatic SR was higher in patients with PEI (4.89; 95% confidence interval, 4.36-5.41) than in those with a normal breath test result (2.99; 95% confidence interval, 2.82-3.16) (P < .001). A direct relationship was found between the SR and the probability of PEI, which increases from 4.2% in patients with an SR less than 2.5 to 92.8% in those with an SR greater than >5.5., Limitations: Single-center study., Conclusions: The degree of pancreatic fibrosis as measured by EUS-guided elastography allows quantification of the probability of PEI in patients with CP., (Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: EUS-guided cholangiopancreatography (ESCP) allows transmural access to biliopancreatic ducts when ERCP fails. Data regarding technical details, safety, and outcomes of ESCP are still unknown., Objective: To evaluate outcomes of ESCP in community and referral centers at the initial development phase of this procedure, to identify the ESCP stages with higher risk of failure, and to evaluate the influence on outcomes of factors related to the endoscopist., Design: Multicenter retrospective study., Setting: Public health system hospitals with experience in ESCP in Spain., Patients: A total of 125 patients underwent ESCP in 19 hospitals, with an experience of <20 procedures., Intervention: ESCP., Main Outcome Measurements: Technical success and complication rates in the initial phase of implantation of ESCP are described. The influence of technical characteristics and endoscopist features on outcomes was analyzed., Results: A total of 125 patients from 19 hospitals were included. Biliary ESCP was performed in 106 patients and pancreatic ESCP was performed in 19. Technical success was achieved in 84 patients (67.2%) followed by clinical success in 79 (63.2%). Complications occurred in 29 patients (23.2%). Unsuccessful manipulation of the guidewire was responsible for 68.2% of technical failures, and 58.6% of complications were related to problems with the transmural fistula., Limitations: Retrospective study., Conclusion: Outcomes of ESCP during its implantation stage reached a technical success rate of 67.2%, with a complication rate of 23.2%. Intraductal manipulation of the guidewire seems to be the most difficult stage of the procedure., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: EUS-guided FNA is an efficacious technique for sampling intraintestinal and extraintestinal mass lesions. However, cytology has limitations to its final yield and accuracy, which may be overcome if histological specimens are provided to the pathologist., Objective: To evaluate feasibility, yield, and diagnostic accuracy of a newly developed 19-gauge, fine-needle biopsy (FNB) device., Design: Multicenter, pooled, cohort study., Setting: Five medical centers., Patients: This study involved 109 consecutive patients with 114 intraintestinal or extraintestinal mass lesions and/or peri-intestinal lymph nodes., Intervention: EUS-guided FNB (EUS-FNB) with a newly developed, 19-gauge, FNB device., Main Outcome Measurements: Percentage of cases in which pathologists classified the sample quality as optimal for histological evaluation and the overall diagnostic accuracy compared with a composite criterion-standard diagnosis., Results: We evaluated 114 lesions (mean [± standard deviation] size 35.1 ± 18.7 mm; 84 malignant [73.7%] and 30 [26.3%] benign). EUS-FNB was technically feasible in 112 lesions (98.24%). Sample quality was adequate for full histological assessment in 102 lesions (89.47%). In 98 cases (85.96%), diagnosis proved to be correct according to criterion-standard diagnosis. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy for diagnosis of malignancy were 90.2%, 100%, 100%, 78.9%, and 92.9%, respectively., Limitations: Use of a surrogate criterion-standard diagnosis, including clinical follow-up when no surgical specimens were available, mainly in benign diagnoses., Conclusion: Performing an EUS-FNB with a new 19-gauge histology needle is feasible for histopathology diagnosis of intraintestinal and extraintestinal mass lesions, offering the possibility of obtaining a core sample for histological evaluation in the majority of cases, with an overall diagnostic accuracy of over 85%., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Differential diagnosis of solid pancreatic masses remains a challenge. EUS elastography, by analyzing tissue stiffness of the mass, may be of help in this setting., Objective: To evaluate the different elastographic patterns of solid pancreatic masses and the diagnostic accuracy of EUS elastography for malignancy., Design: Prospective, consecutive, descriptive study with a second blind evaluation of elastographic patterns for concordance analysis and use of a well-defined reference method for calculation of diagnostic accuracy., Patients: This study involved 130 consecutive patients with solid pancreatic masses and 20 controls with normal pancreases., Intervention: EUS elastography was performed by using a linear Pentax echoendoscope and Hitachi EUB-8500 US., Main Outcome Measurements: Elastographic patterns of solid pancreatic masses and accuracy of the technique for malignancy., Results: Mean (SD) size of the masses was 30.9 (12.5) mm. The final diagnosis was malignant tumor in 78 patients, inflammatory mass in 42 patients, and neuroendocrine tumor in 10 patients. Four elastographic patterns were described, with a high concordance among 2 blinded investigators. A green-predominant pattern, either homogeneous or heterogeneous, excluded malignancy with a high accuracy. On the contrary, a blue-predominant pattern, either homogeneous or heterogeneous, supported the diagnosis of malignant tumor. Sensitivity, specificity, positive and negative predictive values, and overall accuracy of EUS elastography for diagnosis of malignancy were 100%, 85.5%, 90.7%, 100%, and 94.0%, respectively., Limitation: Single-center study., Conclusion: EUS elastography is a useful tool for differential diagnosis of solid pancreatic masses. It provides specific patterns supporting the benign or malignant nature of the disease.