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Background: Instead of choosing one endoscopic ultrasound (EUS) needle over the other, some advocate the use of fine-needle aspiration (FNA) and fine-needle biopsy (FNB) consecutively. We explored the yield of combined use of 20 G FNB and 25 G FNA needles in patients with a suspicious solid gastrointestinal lesion., Methods: Patients from the ASPRO study who were sampled with both needles during the same procedure were included. The incremental yield of dual sampling compared with the yield of single needle use on the diagnostic accuracy for malignancy was assessed for both dual sampling approaches - FNA followed by FNB, and vice versa., Results: 73 patients were included. There were 39 (53 %) pancreatic lesions, 18 (25 %) submucosal masses, and 16 (22 %) lymph nodes. FNA was used first in 24 patients (33 %) and FNB was used first in 49 (67 %). Generally, FNB was performed after FNA to collect tissue for ancillary testing (75 %), whereas FNA was used after FNB to allow for on-site pathological assessment (76 %). Diagnostic accuracy for malignancy of single needle use increased from 78 % to 92 % with dual sampling ( P  = 0.002). FNA followed by FNB improved the diagnostic accuracy for malignancy ( P  = 0.03), whereas FNB followed by FNA did not ( P  = 0.13)., Conclusion: Dual sampling only improved diagnostic accuracy when 25 G FNA was followed by 20 G FNB and not vice versa. As the diagnostic benefit of the 20 G FNB over the 25 G FNA needle has recently been proven, sampling with the FNB needle seems a logical first choice., Competing Interests: Dr. van Riet was a consultant for Cook Medical Devices during the UEGW in 2016. Dr. Bruno is a consultant and lectures for Cook Medical and Boston Scientific., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background and Aim: A recently carried out randomized controlled trial showed the benefit of a novel 20-G fine-needle biopsy (FNB) over a 25-G fine-needle aspiration (FNA) needle. The current study evaluated the reproducibility of these findings among expert academic and non-academic pathologists., Methods: This study was a side-study of the ASPRO (ASpiration versus PROcore) study. Five centers retrieved 74 (59%) consecutive FNB and 51 (41%) FNA samples from the ASPRO study according to randomization; 64 (51%) pancreatic and 61 (49%) lymph node specimens. Samples were re-reviewed by five expert academic and five non-academic pathologists and rated in terms of sample quality and diagnosis. Ratings were compared between needles, expert academic and non-academic pathologists, target lesions, and cytology versus histological specimens., Results: Besides a higher diagnostic accuracy, FNB also provided for a better agreement on diagnosing malignancy (ĸ = 0.59 vs ĸ = 0.76, P < 0.001) and classification according to Bethesda (ĸ = 0.45 vs ĸ = 0.61, P < 0.001). This equally applied for expert academic and non-academic pathologists and for pancreatic and lymph node specimens. Sample quality was also rated higher for FNB, but agreement ranged from poor (ĸ = 0.04) to fair (ĸ = 0.55). Histology provided better agreement than cytology, but only when a core specimen was obtained with FNB (P = 0.004 vs P = 0.432)., Conclusion: This study shows that the 20-G FNB outperforms the 25-G FNA needle in terms of diagnostic agreement, independent of the background and experience of the pathologist. This endorses use of the 20-G FNB needle in both expert and lower volume EUS centers., (© 2019 The Authors. Digestive Endoscopy published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)

Background: There are limited data about the role of endoscopic ultrasound-guided tissue acquisition (EUS-TA), by fine needle aspiration (EUS-FNA) or biopsy (EUS-FNB), in the evaluation of the adrenal glands (AG). The primary aim was to assess the diagnostic yield and safety. The secondary aims were the malignancy predictors, and to create a predictive model of malignancy., Methods: This was a retrospective nationwide study involving all Spanish hospitals experienced in EUS-TA of AGs. Inclusion period was from April-2003 to April-2016. Inclusion criteria: all consecutive cases that underwent EUS-TA of AGs. EUS and cytopathology findings were evaluated. Statistical analyses: diagnostic accuracy of echoendoscopist's suspicion using cytology by EUS-TA, as gold standard; multivariate logistic regression model to predict tumor malignancy., Results: A total of 204 EUS-TA of AGs were evaluated. Primary tumor locations were lung70%, others19%, and unknown11%. AG samples were adequate for cytological diagnosis in 91%, and confirmed malignancy in 60%. Diagnostic accuracy of the endosonographer's suspicion was 68%. The most common technique was: a 22-G (65%) and cytological needle (75%) with suction-syringe (66%). No serious adverse events were described. The variables most associated with malignancy were size>30mm (OR2.27; 95%CI, 1.16-4.05), heterogeneous echo-pattern (OR2.11; 95%CI, 1.1-3.9), variegated AG shape (OR2.46; 95%CI, 1-6.24), and endosonographer suspicion (OR17.46; 95%CI, 6.2-58.5). The best variables for a predictive multivariate logistic model of malignancy were age, sex, echo-pattern, and AG-shape., Conclusions: EUS-TA of the AGs is a safe, minimally invasive procedure, allowing an excellent diagnostic yield. These results suggest the possibility of developing a pre-EUS procedure predictive malignancy model., Competing Interests: The authors have declared that no competing interests exist.

Background: Rapid on-site evaluation (ROSE) of cytological specimensacquired with EUS-guided fine needle aspiration (EUS-FNA) represents the most accurate available technique to reach a definitive diagnosis in patients with pancreatic solid masses. Recently, needles with high histological yield have been developed for EUS-guided fine needle biopsy (EUS-FNB), with which the need for ROSE can be potentially overcome., Aims: The primary aim is to compare the diagnostic accuracy of EUS-FNB with or without ROSE. The main endpoint will be measured against the gold standard diagnosis (surgical pathology whenever available or diagnostic work-up in agreement with a clinical course of at least six months). Secondary endpoints include: (a) safety; (b) presence of tissue core; (c) quality of specimens; (d) time of the sampling procedure. Reliability of macroscopic on-site evaluation (MOSE) by endosonographers will be also assessed., Methods: FROSENOR is an international randomized non-inferiority ongoing study at sixteen centers in four continents. Eight hundred patients will be randomized in two arms (EUS-FNB + ROSE vs. EUS-FNB alone) and outcomes compared. Sample size has been calculated in order to demonstrate the non-inferiority of FNB alone. Randomization and data collection will be performed online., Discussion: This study will ascertain if ROSE is still needed when performing EUS-FNB of solid pancreatic lesions., (Copyright © 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

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.)

Pancreatic cancer (PC) is one of the deadliest cancers with a 5-year overall survival of less than 6%. Due to its insidious clinical course and unspecific symptoms, the diagnosis is usually late, with only 15-20% patients presenting with potentially curable disease. It is, therefore, extremely important to identify patients with PC at early stages of the disease when tumors may be amenable to surgical resection. For unresectable and borderline resectable PC it is consensual to perform a biopsy to have a cyto/histological confirmation of malignancy before treatment. However, for patients presenting with promptly resectable disease, the role of biopsy is more debatable. There are, in the literature, arguments both for and against the usefulness of a preoperative biopsy. Endoscopic ultrasound (EUS) is an important technique assisting in the diagnosis and staging of PC. EUS-guided tissue acquisition is a well-established tool to demonstrate the malignant nature of a pancreatic lesion. This review focuses on the role of EUS in the diagnosis and staging of PC, and highlights the controversy related to the role of EUS-guided tissue acquisition in the preoperative assessment of patients presenting with promptly resectable tumors (early PC)., (Copyright © 2018 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

For routine EUS-guided sampling of solid masses and lymph nodes (LNs) ESGE recommends 25G or 22G needles (high quality evidence, strong recommendation); fine needle aspiration (FNA) and fine needle biopsy (FNB) needles are equally recommended (high quality evidence, strong recommendation).When the primary aim of sampling is to obtain a core tissue specimen, ESGE suggests using 19G FNA or FNB needles or 22G FNB needles (low quality evidence, weak recommendation).ESGE recommends using 10-mL syringe suction for EUS-guided sampling of solid masses and LNs with 25G or 22G FNA needles (high quality evidence, strong recommendation) and other types of needles (low quality evidence, weak recommendation). ESGE suggests neutralizing residual negative pressure in the needle before withdrawing the needle from the target lesion (moderate quality evidence, weak recommendation).ESGE does not recommend for or against using the needle stylet for EUS-guided sampling of solid masses and LNs with FNA needles (high quality evidence, strong recommendation) and suggests using the needle stylet for EUS-guided sampling with FNB needles (low quality evidence, weak recommendation).ESGE suggests fanning the needle throughout the lesion when sampling solid masses and LNs (moderate quality evidence, weak recommendation).ESGE equally recommends EUS-guided sampling with or without on-site cytologic evaluation (moderate quality evidence, strong recommendation). When on-site cytologic evaluation is unavailable, ESGE suggests performance of three to four needle passes with an FNA needle or two to three passes with an FNB needle (low quality evidence, weak recommendation).For diagnostic sampling of pancreatic cystic lesions without a solid component, ESGE suggests emptying the cyst with a single pass of a 22G or 19G needle (low quality evidence, weak recommendation). For pancreatic cystic lesions with a solid component, ESGE suggests sampling of the solid component using the same technique as in the case of other solid lesions (low quality evidence, weak recommendation).ESGE does not recommend antibiotic prophylaxis for EUS-guided sampling of solid masses or LNs (low quality evidence, strong recommendation), and suggests antibiotic prophylaxis with fluoroquinolones or beta-lactam antibiotics for EUS-guided sampling of cystic lesions (low quality evidence, weak recommendation). ESGE suggests that evaluation of tissue obtained by EUS-guided sampling should include histologic preparations (e. g., cell blocks and/or formalin-fixed and paraffin-embedded tissue fragments) and should not be limited to smear cytology (low quality evidence, weak recommendation)., Competing Interests: Competing interests: M. Barthet has provided consultancy and research support to Boston Scientific (from September 2015). S. Carrara has provided a paid lecture/course for Boston Scientific and for Olympus (2016). P. Deprez is providing paid consultancy to Boston Scientific and to Cook (January 2016 to December 2017, for both); his department is receiving sponsorship from Boston Scientific, Olympus, and Cook (January 2016 to December 2017, for all). J. Iglesias-Garcia has been a speaker and provided teaching activities for Boston Scientific (from 2016). B. Napoleon has received fees from Boston Scientific for educational workshops (2014 to present), and fees from Olympus for organisation of EUS 2016; his department has received support from Olympus for the organization of a meeting on contrast EUS (2015). J.E. van Hooft’s department is currently receiving research grants from Cook Medical, Boston Scientific, and Olympus; since 2015 she has been a member of EUS platform, a national network of professionals. G.P. Aithal, P.G. Arcidiacono, P. Bastos, J.-M. Dumonceau, P. Eisendrath, G. Fernández-Esparrach, A. Fornelli, A. Gines, C. Hassan, C. Jenssen, P. Kaye, A. Larghi, M. Polkowski, and A. Seicean have no competing interests., (© Georg Thieme Verlag KG Stuttgart · New York.)

Aim: To evaluate factors that influence the diagnostic accuracy of endoscopic ultrasound (EUS)-guided tissue acquisition for lymph node enlargement in the absence of an on-site pathologist., Methods: A retrospective analysis of patients who underwent EUS-guided tissue acquisition for the pathological diagnosis of lymph node enlargement between April 2012 and June 2015 is reported. Tissue acquisition was performed with both cytology and biopsy needles of different calibers. The variables evaluated were lymph node location and size, number of passes and type of needle used. Final diagnosis was based on surgical histopathology or, in non-operated cases, on EUS-guided tissue acquisition and imaging assessment with a minimum clinical follow-up of 6 mo., Results: During the study period, 168 lymph nodes with a median size of 20.3 mm (range 12.5-27) were sampled from 152 patients. Ninety lymph nodes (53.6%) were located at mediastinum, and 105 (62.5%) were acquired with biopsy needles. The final diagnosis was benign/reactive origin in 87 cases (51.8%), malignant in 65 cases (38.7%), and lymphoma in 16 cases (9.5%). The sensitivity, specificity, positive predictive value and negative predictive value for the detection of malignancy were 74.1%, 100%, 100% and 80.6%, respectively. The overall accuracy was 87.5% (95%CI: 81.7-91.7). No variables were independently associated with a correct final diagnosis according to the multivariate analysis., Conclusion: EUS-guided tissue acquisition is a highly accurate technique for assessing lymph node enlargement. None of the variables evaluated were associated with diagnostic accuracy., Competing Interests: Conflict-of-interest statement: We have no financial relationships to disclose.

Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) has become an essential tool in the management of multiple diseases. Its accuracy is related to different aspects of the technique, one of the most important being the experience and interaction of the endosonographer and pathologist. Certain studies over the past years have highlighted the importance of having rapid on-site evaluation (ROSE) of samples obtained at the time of EUS-FNA. We have reviewed the role of ROSE, performed by the same endosonographer, a cytotechnologist and an expert cytopathologist. The available data suggest that ROSE (either by the endosonographer, the cytotechnologist, or the cytopathologist) improves sample adequacy and diagnostic yield, with the best option to have ROSE performed by an expert cytopathologist. However, if non-ROSE accuracy is already very high, any improvement is harder to achieve.

Background and Study Aim: Poorly differentiated/high grade pancreatic ductal adenocarcinoma (PDAC) is associated with an early unfavorable outcome, and patients with these tumors may be candidates for neo-adjuvant treatment. Endoscopic ultrasound-guided pancreatic fine-needle biopsy (EUS-FNB) may, in theory, allow preoperative assessment of PDAC histological grading. The aim of the current study was to assess the interobserver agreement and accuracy of preoperative PDAC grading from EUS-FNB specimens., Methods: Data from 42 postsurgical PDAC patients who had undergone preoperative EUS-FNB were retrieved. Four experienced pathologists independently reviewed the EUS-FNB slides and reported tumor grading (well, moderately, or poorly differentiated). Agreement among pathologists for grading of preoperative EUS-FNB samples was expressed by using Cohen's or Fleiss' kappa statistic, as appropriate. Postsurgical PDAC grading was used as the gold standard to assess the cumulative accuracy of EUS-FNB for the preoperative prediction of PDAC grading., Results: The kappa values for PDAC grading on EUS-FNB specimens ranged from 0.09 to 0.41. The total agreement among the four pathologists was only fair (κ = 0.27; 95 % confidence interval [CI] 0.14 - 0.38). When tumor grades were grouped as well or moderately differentiated vs. poorly differentiated, kappa values ranged from 0.19 to 0.50, with only a fair overall agreement (κ = 0.27; 95 %CI 0.21 - 0.49). The accuracy of preoperative grading from EUS-FNB was 56 % (75/134 readings; 95 %CI 40 % - 65 %), with mean sensitivity and specificity to detect a high grade, poorly differentiated tumor of 41 % (95 %CI 19 % - 54 %) and 78 % (53/68 readings; 95 %CI 60 % - 99 %), respectively., Conclusions: Preoperative EUS-FNB-based histological grading of PDAC is unreliable, and current results do not support the use of this information in clinical practice. This appears to be due to suboptimal interobserver agreement among pathologists and an overall low accuracy in predicting postsurgical grading., (© Georg Thieme Verlag KG Stuttgart · New York.)

Endoscopic ultrasound (EUS) has become an essential tool for the study of pancreatic diseases. Specifically, EUS plays a pivotal role evaluating patients with a known or suspected pancreatic mass. In this setting, differential diagnosis remains a clinical challenge. EUS-guided fine-needle aspiration (FNA) and fine-needle biopsy (FNB) have been proven to be safe and useful tools in this setting. EUS-guided FNA and FNB, by obtaining cytological and/or histological samples, are able to diagnose pancreatic lesions with high sensitivity and specificity. In this context, several methodological features, trying to increase the diagnostic yield of EUS-guided FNA and FNB, have been evaluated. In this review, we focus on the role of rapid on-site evaluation (ROSE). From data reported in the literature, ROSE may increase diagnostic yield of EUS-FNA specimens by 10%-30%, and thus, diagnostic accuracy. However, we should point out that many recent studies have reported adequacy rates of > 90% without ROSE, indicating that, perhaps, at high-volume centers, ROSE may not be indispensable to achieve excellent results. The use of ROSE can be considered important during the learning curve of EUS-FNA, and also in hospital with diagnostic accuracy rates < 90%.

Background: The option of obtaining tissue samples for histological examination during endoscopic ultrasound (EUS) has theoretical and practical advantages over cytology alone. The aim of this study was to evaluate the feasibility, yield, and diagnostic accuracy of a new EUS 22-G fine-needle biopsy (FNB) device in patients with solid pancreatic masses in a multicenter, prospective study., Methods: All consecutive patients who underwent EUS-guided fine-needle biopsy (EUS-FNB) using a newly developed 22-G FNB needle between September 2010 and October 2010 were enrolled in the study. The EUS-FNB technique was standardized among the participating endoscopists. Only a single needle pass was performed., Results: A total of 61 patients (35 males, mean age 64.2 ± 12.4 years) with solid pancreatic masses with a mean size of 32.4 ± 8.5 mm (range 13-90 mm) participated. EUS-FNB was performed through the duodenum in 35 cases (57.4 %) and was technically feasible in all but one of the 61 (98.4 %) patients without complications. Tissue samples for histological examination were obtained from 55 patients (90.2 %) and were deemed adequate in 54 of the cases (88.5 %). The diagnoses established by EUS-FNB were adenocarcinoma (39 patients), neuroendocrine tumors (5), chronic focal pancreatitis (5), sarcoma (2), lymphoma (1), acinar cellular tumor (1), and pancreatic metastasis from renal cell carcinoma (1). In an intention-to-treat (ITT) analysis, sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for the histologic diagnosis of a pancreatic mass were 87.5, 100, 100, 41.7, and 88.5 %, respectively., Conclusions: EUS-FNB was technically feasible in 98 % of patients with a solid pancreatic mass. A suitable sample for histological evaluation was obtained in 88.5 % of the cases after only one single needle pass. The apparently low negative predictive value is likely to be improved by increasing the number of needle passes.