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Shailesh V Shrikhande,1 VG Mohan Prasad,2 J Enrique Domínguez-Muñoz,3 Kevin E Weigl,4 Kushal D Sarda5 1Division of Cancer Surgery and Gastrointestinal and Hepato-Pancreato-Biliary Service, Tata Memorial Hospital, Mumbai, Maharashtra, India; 2Department of Gastroenterology, Dr. M.G.R. Medical University and VGM Hospital, Coimbatore, Tamil Nadu, India; 3Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain; 4Department of Gastroenterology, Abbott Laboratories GmbH, Hannover, Germany; 5Established Pharmaceuticals Division – Medical Affairs, Abbott India Ltd, Mumbai, Maharashtra, IndiaCorrespondence: Kushal D SardaAbbott India Ltd, Floor 16, Godrej BKC, Plot No. C – 68, Bandra-Kurla Complex, Near MCA Club, Bandra (E), Mumbai, 400051, Maharashtra, IndiaTel +91-22-38160938Fax +91 22 38162400Email kushal.sarda@abbott.comPurpose: Pancreatic enzyme replacement therapy (PERT) involves exogenous enzyme supplementation and is used in the treatment of pancreatic exocrine insufficiency. Clinical efficacy of PERT preparations is a function of physical properties and release kinetics that vary between commercially available products. In this study, we evaluated the physical properties, in vitro dissolution, and release kinetics of commercially available pancreatic enzyme preparations available in the Indian market.Methods: Physical properties such as particle size distribution and water content of the capsules were measured by dynamic light scattering and Karl–Fischer titration method, respectively. An analytical procedure based on the European pharmacopoeia (EP) method was used to determine lipase activity, and a modified United States pharmacopoeia (USP)–based method was used for dissolution studies. Enzyme release was ascertained under gastroduodenal conditions in buffered media.Results: Considerable variations in physical properties such as particle size and water content were observed between pancreatic enzyme preparations. Some preparations failed to meet the labeled lipase content as per USP standards (> 90% label claim) and showed inconsistent release behavior (> 5% relative standard deviation).Conclusion: Differences exist between pancreatic enzyme preparations in terms of physical properties, dissolution, and release behavior that can affect their clinical efficacy. The present study suggests, therefore, that these preparations should not be used interchangeably.Keywords: pancreatic enzyme, physical properties, in vitro dissolution, lipase activity, release kinetics

Background: Endoscopic retrograde cholangiopancreatography (ERCP) with fully covered self-expandable metal stent (FCSEMS) placement is the preferred approach for biliary drainage in patients with suspected distal malignant biliary obstruction (MBO). However, FCSEMS placement is associated with a high risk of post-ERCP pancreatitis (PEP). Endoscopic sphincterotomy prior to FCSEMS placement may reduce PEP risk., Objective: To compare endoscopic sphincterotomy to no sphincterotomy prior to FCSEMS placement., Design: This multicentre, randomised, superiority trial was conducted in 17 hospitals and included patients with suspected distal MBO. Patients were randomised during ERCP to receive either endoscopic sphincterotomy (sphincterotomy group) or no sphincterotomy (control group) prior to FCSEMS placement. The primary outcome was PEP within 30 days. Secondary outcomes included procedure-related complications and 30-day mortality. An interim analysis was performed after 50% of patients (n=259) had completed follow-up., Results: Between May 2016 and June 2023, 297 patients were included in the intention-to-treat analysis, with 156 in the sphincterotomy group and 141 in the control group. After the interim analysis, the study was terminated prematurely due to futility. PEP did not differ between groups, occurring in 26 patients (17%) in the sphincterotomy group compared with 30 patients (21%) in the control group (relative risk 0.78, 95% CI 0.49 to 1.26, p=0.37). There were no significant differences in bleeding, perforation, cholangitis, cholecystitis or 30-day mortality., Conclusion: This trial found that endoscopic sphincterotomy was not superior to no sphincterotomy in reducing PEP in patients with distal MBO. Therefore, there was insufficient evidence to recommend routine endoscopic sphincterotomy prior to FCEMS placement., Trial Registration Number: NL5130., Competing Interests: Competing interests: JvH has received research support from Cook Medical and acted as lecturer for Cook Medical, Boston Scientific and Falk, and as consultant for Olympus, outside the submitted work. RPV received a research grant and acted as consultant for Boston Scientific, outside the submitted work. PF acted as a consultant for Cook Endoscopy and Olympus, outside the submitted work. RvW acted as a consultant for Boston Scientific, outside the submitted work. All other authors declare that they have no competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Focal liver lesions (FLL) often require cytohistological evaluation. Endoscopic Ultrasound (EUS)-guided tissue acquisition (EUS-TA) is highly accurate in diagnosing pancreatic and gastrointestinal malignancies. The aim of our study was to evaluate the role of EUS-TA in the characterization of FLL., Methods: A retrospective analysis of a prospective database of patients who underwent EUS-TA for the evaluation of FLL. Diagnostic yield, adverse events and factors associated with diagnostic yield were evaluated as endpoints. The effect of variables such as needle size, lesion size, rapid on-site evaluation (ROSE) and the use of cytological or histological needles were analyzed., Results: A total of 114 cases were included (mean age 68.05 ± 11.35 years, 64 male). A correct diagnosis was made using EUS-TA in 100 of the 114 cases (diagnostic yield of 88%). The EUS-TA of additional extrahepatic lesions during the same EUS procedure increased the diagnostic yield to 94%. No adverse events were reported. Multivariate analysis did not identify any factor influencing the diagnostic yield., Conclusions: EUS-TA is a highly accurate and safe technique for the differential diagnosis of FLL and could be considered as the primary approach in this setting.

Endoscopic ultrasound (EUS) is an essential technique for the management of several diseases. Over the years, new technologies have been developed to improve and overcome certain limitations related to EUS-guided tissue acquisition. Among these new methods, EUS-guided elastography, which is a real-time method for the evaluation of tissue stiffness, has arisen as one of the most widely recognized and available. At present, there are available two different systems to perform an elastographic evaluation: strain elastography and shear wave elastography. Strain elastography is based on the knowledge that certain diseases lead to a change in tissue hardness while shear wave elastography monitored shear-wave propagation and measures its velocity. EUS-guided elastography has shown in several studies high accuracy in differentiating benign from malignant lesions from many different locations, mostly in the pancreas and lymph nodes. Therefore, nowadays, there are well-established indications for this technology, mainly for supporting the management of pancreatic diseases (diagnosis of chronic pancreatitis and differential diagnosis of solid pancreatic tumors) and characterization of different diseases. However, there are more data on new potential indications for the near future. In this review, we will present the theoretical bases of this technology and we will discuss the scientific evidence to support its use.

Background and Aims: Submucosal injection agents are widely used solutions in gastric polyp resection techniques. Currently, many different solutions are used in clinical practice, but most are not authorised for this use or are not biopharmaceutical characterised. The objective of this multidisciplinary work is to test the efficacy of a novel thermosensitive hydrogel designed specifically for this indication., Methods: A mixture design of various components (Pluronic®, hyaluronic acid and sodium alginate) was carried out to select the combination with optimal properties for this use. Three final thermosensitive hydrogels were selected on which biopharmaceutical characterisation was performed and stability and biocompatibility were analysed. Efficacy in maintaining elevation was tested ex vivo on pig mucosa and in vivo in pigs RESULTS: The mixture design allowed selection of the ideal combinations of agents for the characteristics sought. The thermosensitive hydrogels studied showed high values of hardness and viscosity at 37 °C, maintaining good syringeability. One of them demonstrated superiority in maintaining polyp elevation in the ex vivo assay and non-inferiority in the in vivo assay., Conclusion: The thermosensitive hydrogel specifically designed for this use is promising both for its biopharmaceutical characteristics and for its demonstrated efficacy. This study lays the foundation for evaluating the hydrogel in humans., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Anxo Fernandez Ferreiro reports financial support was provided by Axencia Galega de Innovación. Anxo Fernandez Ferreiro reports financial support was provided by Carlos III Health Institute., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Aim: The aim of this study was to evaluate and compare the presence and impact of Gastrointestinal (GI) symptoms, physical and psychological disturbances on patients' QoL after sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB) and biliopancreatic diversion with duodenal switch (BPD/DS)., Methods: A prospective, observational, cross-sectional, comparative study was carried-out. GI symptoms and patients' QoL were evaluated by the SF-36 questionnaire and the GI quality of life index (GIQLI). Correlation between GI symptoms, psychological disturbances and QoL scores was analysed., Results: 95 patients were included (mean age 50.5 years, range 22-70; 76 females). Presence of GI symptoms was a consistent finding in all patients, and postprandial fullness, abdominal distention and flatulence had a negative impact on patients' QoL. Patients after SG showed a worsening of their initial psychological condition and the lowest QoL scores. Patients after RYGB showed the best GI symptoms-related QoL., Conclusions: Both restrictive and malabsorptive bariatric surgical procedures are associated with GI symptoms negatively affecting patients' QoL. Compared to SG and BPD/DS, patients after RYGB showed the best GI symptoms-related QoL, which can be used as additional information to help in the clinical decision making of the bariatric procedure to be performed., (Copyright © 2022 Elsevier España, S.L.U. All rights reserved.)

Endoscopic ultrasound (EUS) is an essential technique for the management of several diseases. Over the years, new technologies have been developed because to improve and overcome certain limitations related to EUS guided tissue acquisition. Among these new methods, EUS guided elastography and contrast enhanced EUS has arisen as the most widely recognized and available. We will review in this manuscript the different techniques of elastography and contrast enhancement. Nowadays, there are well establish indications for advance imaging, mainly for supporting the management of pancreatic diseases (diagnosis of chronic pancreatitis and differential diagnosis of solid and cystic pancreatic tumors) and characterization of lymph nodes. However, there are more data on new potential indications for the near future., Competing Interests: Declaration of competing interest Julio Iglesias-Garcia MD, PhD; International Advisor and Teaching activities for Pentax Medical Company. Jose Lariño-Noia MD, PhD; Daniel de la Iglesia-García MD, PhD; J. Enrique Dominguez-Muñoz MD, PhD No potential conflicts of interest relevant to this article., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Different surveillance strategies for patients with low-risk branch-duct (BD) intraductal papillary neoplasm (IPMN) have been described. The aim of this study was to describe the natural history of low-risk BD-IPMN, and to identify risk factors for the development of worrisome features (WF)/high-risk stigmata (HRS) and of pancreatic malignancies., Methods: This was a multicentre retrospective study of patients with BD-IPMN who were under active surveillance between January 2006 and December 2015. Patients were eligible if they had a low-risk lesion and had a minimum follow-up of 24 months. Outcomes were development of WF/HRS or cytologically/histologically confirmed malignant IPMN., Results: Of 837 patients included, 168 (20 per cent) developed WF/HRS. At the end of the observation time, 132 patients (79 per cent) with WF/HRS were still under surveillance without progression to pancreatic cancer. Factors associated with the development of WF or HRS in multivariable analysis included localized nodules (versus diffuse: hazard ratio (HR) 0.43, 95 per cent c.i. 0.26 to 0.68), cyst size 15-19 mm (versus less than 15 mm: HR 1.88, 1.23 to 2.87) or at least 20 mm (versus less than 15 mm: HR 3.25, 2.30 to 4.60), main pancreatic duct size over 3 mm (versus 3 mm or less: HR 2.17, 1.41 to 3.34), and symptoms at diagnosis (versus no symptoms: HR 2.29, 1.52 to 3.45). Surveillance in an endoscopy-oriented centre was also associated with increased detection of WF or HRS (versus radiology-oriented: HR 2.46, 1.74 to 3.47)., Conclusion: Conservative management of patients with low-risk BD-IPMN is safe and feasible., (© The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd.)

Endoscopic ultrasound-guided biliary drainage, mainly choledochoduodenostomy, is commonly used as rescue therapy after Endoscopic Retrograde Cholangiopancreatography (ERCP) in malignant distal biliary obstruction due to un-resectable pancreatic cancer. An alternative when the cystic duct is patent and choledochoduodenostomy is not feasible is performing an Endoscopic Ultrasound-gallbladder drainage. The advent of the Lumen Apposing Metal Stents (LAMS) has shortened and simplified this procedure. However, many concerns exist about the performance of these procedures with metal stents preoperatively in resectable tumors. The evidence about Endoscopic Ultrasound-gallbladder drainage before surgery of pancreatic cancer is scarce. An emergent Endoscopic Ultrasound (EUS)-gallbladder drainage (cholecysto-duodenostomy) was performed due to acute cholangitis in the setting of a resectable pancreatic tumor. Surgery after neoadjuvant therapy was done three months later. A complete resection of tumor was feasible. EUS-guided gallbladder drainage using LAMS does not preclude performing a complete resection of a pancreatic head tumor., (© 2021. Japanese Society of Gastroenterology.)

Background: Gastrointestinal anatomical changes after restrictive and malabsorptive bariatric surgery lead to important disturbances in the process of digestion and absorption of nutrients and could lead to exocrine pancreatic insufficiency (EPI)., Objective: The aim of the present study was to evaluate and to compare pancreatic function and the dynamic of digestion and absorption of nutrients after restrictive and malabsorptive bariatric surgical procedures., Setting: University Hospital of Santiago de Compostela, Santiago de Compostela, Spain., Methods: A prospective, observational, cross-sectional, comparative study of patients after sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and biliopancreatic diversion with duodenal switch (BPD/DS) was carried out. Patients with obesity who did not undergo surgery were included as control group. Pancreatic function and the dynamic of digestion and absorption of nutrients were evaluated by the 13 C-mixed triglyceride ( 13 C-MTG) breath test. Six-hour 13 C-cumulative recovery rate ( 13 C-CRR), 13 C exhalation peak, and 1-hour maximal 13 C-CRR were calculated., Results: One-hundred five patients were included (mean age, 49.8 yr; 84 women). Six-hour 13 C-CRR was significantly reduced after BPD/DS (P < .001) but not after SG and RYGB. EPI was present in 75% of patients after BPD/DS, 8.3% of patients after RYGB, and 4.3% of patients after SG. Compared with the control group who did not undergo surgery, digestion and absorption of nutrients tended to occur earlier after SG, whereas it was delayed after RYGB and mainly after BPD/DS (P < .001)., Conclusion: Bariatric surgery significantly alters the dynamic of the digestive process. EPI is very common after BPD/DS, frequent after RYGB, and less frequent after SG. This information is clinically relevant since EPI is a treatable condition associated with symptoms, nutritional deficiencies, and complications., (Copyright © 2021 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: To characterise the association between type 2 diabetes mellitus (T2DM) subtypes (new-onset T2DM (NODM) or long-standing T2DM (LSDM)) and pancreatic cancer (PC) risk, to explore the direction of causation through Mendelian randomisation (MR) analysis and to assess the mediation role of body mass index (BMI)., Design: Information about T2DM and related factors was collected from 2018 PC cases and 1540 controls from the PanGenEU (European Study into Digestive Illnesses and Genetics) study. A subset of PC cases and controls had glycated haemoglobin, C-peptide and genotype data. Multivariate logistic regression models were applied to derive ORs and 95% CIs. T2DM and PC-related single nucleotide polymorphism (SNP) were used as instrumental variables (IVs) in bidirectional MR analysis to test for two-way causal associations between PC, NODM and LSDM. Indirect and direct effects of the BMI-T2DM-PC association were further explored using mediation analysis., Results: T2DM was associated with an increased PC risk when compared with non-T2DM (OR=2.50; 95% CI: 2.05 to 3.05), the risk being greater for NODM (OR=6.39; 95% CI: 4.18 to 9.78) and insulin users (OR=3.69; 95% CI: 2.80 to 4.86). The causal association between T2DM (57-SNP IV) and PC was not statistically significant (OR LSDM =1.08, 95% CI: 0.86 to 1.29, OR NODM =1.06, 95% CI: 0.95 to 1.17). In contrast, there was a causal association between PC (40-SNP IV) and NODM (OR=2.85; 95% CI: 2.04 to 3.98), although genetic pleiotropy was present (MR-Egger: p value=0.03). Potential mediating effects of BMI (125-SNPs as IV), particularly in terms of weight loss, were evidenced on the NODM-PC association (indirect effect for BMI in previous years=0.55)., Conclusion: Findings of this study do not support a causal effect of LSDM on PC, but suggest that PC causes NODM. The interplay between obesity, PC and T2DM is complex., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose of Review: Pancreatic function tests are mainly used for the diagnosis of exocrine pancreatic insufficiency (EPI) in patients with pancreatic diseases or after pancreatic or gastric surgery. Breath tests evaluate not just pancreatic secretion but the digestion capacity of the pancreas. These tests are good candidates for the diagnosis of EPI as they are noninvasive, accurate and easy to apply to clinical practice., Recent Findings: The C-labelled mixed triglyceride (MTG) breath test has been optimized and validated against adequate reference methods for the diagnosis of EPI in patients with chronic pancreatitis and for the evaluation of the efficacy of pancreatic enzyme replacement therapy (PERT). In addition, reported C-MTG breath test results in patients with other pancreatic diseases and after pancreatic and gastric surgery support the accuracy and clinical applicability of this test. The evidence of pancreatic function breath tests with other C-labelled substrates is limited., Summary: Increasing evidence supports the accuracy and clinical usefulness of the C-MTG breath test for the diagnosis of EPI and the evaluation of the efficacy of PERT in different clinical conditions. Commercial availability of this test is required for a wide clinical use. The use of optimized and validated breath test protocols is mandatory.

Solid pancreatic lesions include mainly adenocarcinoma, neuroendocrine tumors pancreatic cystic neoplasms with solid component, solid pseudopapillary tumor, pancreatoblastoma, pancreatic lymphoma, and pancreatic metastasis. The most frequent pancreatic lesion is the adenocarcinoma, representing between 70% and 95% of all solid pancreatic neoplasm. The diagnosis of these lesions can be a challenge and currently, there are different imaging techniques such as CT scan, EUS and MRI with high sensitivity and specificity. The most widely used technique for the initial evaluation is the CT scan with a sensitivity between 76% and 92% for the diagnosis of pancreatic cancer. The EUS has a sensitivity for the detection of pancreatic lesions of around 98% and is accepted to be the most sensitive technique for the detection of small pancreatic tumors (<2 cm). The MRI, with a very high soft-tissue contrast resolution, provides an accuracy in the detection and staging of adenocarcinoma of 90-100%. A multimodality approach is usually necessary in patients with clinical suspicion of pancreatic lesion. The EUS is required for the local evaluation of the relation of the lesion with vessels and for tissue acquisition and the CT scan and/or MRI is usually required for the local and distance staging in case of pancreatic cancer. The purpose of this review is to provide an overview of solid pancreatic lesions and the role of the different imaging techniques in their evaluation.

Purpose of Review: Pancreatic exocrine insufficiency (PEI) is one of the well known causes of malabsorption syndrome. An insufficient secretion of pancreatic enzymes and bicarbonate secondary to different pancreatic diseases and upper gastrointestinal and pancreatic surgery leads to maldigestion and malabsorption of nutrients. Patients with PEI may present with symptoms of malabsorption and different nutritional deficiencies. Recent data support the high clinical relevance of PEI and its treatment., Recent Findings: Deficiencies of fat-soluble vitamins, proteins, micronutrients and antioxidants in patients with PEI are associated not only with an increased risk of osteoporosis and sarcopenia but also of cardiovascular events and mortality. Pancreatic enzyme replacement therapy (PERT) allows improving fat and protein digestion, relieving maldigestion-related symptoms, normalizing the nutritional status, and improving quality of life of patients with PEI. Recent data support the efficacy of PERT on survival in patients with pancreatic cancer. Dose of oral pancreatic enzymes should be adequate to normalize the nutritional status of PEI patients., Summary: Increasing evidence supports the relevance of PEI management by dietary advice and appropriate PERT. Well designed and powered randomized, placebo-controlled clinical trials are needed to further evaluate the clinical impact of PEI and its treatment in clinical practice.

Purpose of Review: Pancreatic exocrine insufficiency (PEI), defined as a secretion of pancreatic enzymes and bicarbonate insufficient to maintain a normal digestion, is a frequent but frequently underdiagnosed and undertreated condition. PEI may be secondary to different pancreatic diseases and extrapancreatic conditions. Recent data support the high clinical relevance of PEI and its treatment., Recent Findings: Together with symptoms of maldigestion, PEI is associated with nutritional deficiencies leading to osteoporosis, low-trauma fractures, sarcopenia and increased mortality. No single widely available test allows to diagnose PEI accurately. Diagnosis of PEI requires the evaluation of symptoms, nutritional markers and a noninvasive pancreatic function test in the appropriate clinical context. Pancreatic enzyme replacement therapy (PERT) improves digestion, symptoms, nutritional status and quality of life of patients with PEI. In addition, PERT is associated with a longer survival in patients with unresectable pancreatic cancer and after surgery for pancreatic cancer or chronic pancreatitis., Summary: Awareness of PEI in different clinical conditions is required. Nutritional advice and appropriate PERT are mandatory to reduce the morbidity and mortality associated with PEI. Further studies on the clinical impact of PEI and its treatment are needed, especially in diseases other than chronic pancreatitis and cystic fibrosis.

Background and Goal: Predicting relapse in inflammatory bowel disease (IBD) patients could allow early changes in therapy. We aimed at evaluating the accuracy of consecutive fecal calprotectin (FC) measurements to predict flares in IBD patients under maintenance treatment with anti-tumor necrosis factor (TNF) drugs., Study: A prospective longitudinal cohort study with 16-month follow-up period was designed. IBD patients in clinical remission for at least 6 months under anti-TNF therapy were included. FC was quantified at 4-month intervals for 1 year, and patients were clinically evaluated for relapse at 2-month intervals. Diagnostic accuracy of FC for predicting relapse was evaluated by receiver-operating characteristic curve analysis., Results: In total, 95 of 106 included patients finalized the study and were analyzed (median age 44 y, 50.5% female, 75% with Crohn's disease). A total of 30 patients (31.6%) had a relapse over follow-up. FC concentration was significantly higher in patients who relapsed (477 μg/g) than in patients who maintained in remission (65 μg/g) (P<0.005). The optimal cutoff to predict remission was 130 μg/g (negative predictive value of 100%), and 300 μg/g to predict relapse (positive predictive value of 78.3%)., Conclusions: FC is a good predictor of clinical relapse and a particularly good predictor of remission over the following 4 months in patients with IBD on maintenance therapy with anti-TNF drugs. FC levels <130 μg/g is consistently associated with maintained disease remission, whereas concentrations >300 μg/g allow predicting relapse with a high probability at any time over the following 4 months.

Background/objectives: To evaluate the agreement between the imaging modalities MRI-MRCP and EUS in cystic lesions of the pancreas which were thought to be a BD-IPMN., Methods: Multicenter retrospective study included all patients between 2010 and 2015 with a suspected BD-IPMN who underwent an EUS and MRI-MRCP within 6 months or less of each other. Location, number, size, worrisome features and high-risk stigmata were evaluated. Interobserver agreement was evaluated by Kappa score., Results: 173 patients were included (97 UHSC, 76 UCLH-RFH), mean age 65 (range 25-87 years), 66 males. When comparing both modalities there was good agreement for the location of the cyst. The median lesion size was larger by MRI-MRCP than EUS although it was not significant. With regards to worrisome features, there was moderate agreement for main PD of 5-9 mm and abrupt change (k = 0.45 and 0.52). Fair agreement was seen for the cyst wall thickening (k = 0.25). No agreement was seen between the presence of non-enhanced mural nodules or lymphadenopathy (k < 0). With regards to high-risk stigmata, poor agreement was obtained for the detection of an enhanced solid component (k = 0.12). No agreement was observed for main PD > 10 mm (k < 0)., Conclusions: In this multicentre study of patients with a BD-IPMN under active surveillance, most disagreement between these modalities was seen in the proximal pancreas. There was generally only minimal concordance between the imaging findings of EUS and MRI-MRCP for the detection of high-risk stigmata and worrisome features., (Copyright © 2018 IAP and EPC. All rights reserved.)

EUS-FNA is often performed in the evaluation of Cystic Pancreatic Lesions (CPL) for a better preoperative characterization. The objective is to identify premalignant lesions as Mucinous Cystic Neoplasms, and/or a malignant transformation of them (adenocarcinoma). The role of cytological evaluation in this setting is discouraging and intracystic markers analysis, mainly CEA, lacks of a good specificity for the detection of mucinous neoplasms. New devices and approaches have emerged to overcome these problems as the cytology brush (Echobrush), the small mini-biopsy foceps, the cystoscopy and the needle Confocal LASER Endomicroscopy (nCLE), showing in some studies good rates of accuracy for distinguishing among mucinosus and non-mucinous neoplasms. However, intracystic molecular marker analysis, by identifying mutations in DNA of particular genes as KRAS,GNAS,VHL, CDKN2A and others constitute the most relevant advancement of last years and will contribute in the next future to a better management of CPL. The role of EUS-FNA according to international guidelines is still controversial. While 2012 Fukuoka guidelines are restrictive in their indications AGA 2015 guidelines support it when high risk features are present, enhancing the role of the cytological evaluation in taking decisions., Competing Interests: There are no conflicts of interest

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.

Background: Contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) and quantitative-elastography endoscopic ultrasound (QE-EUS) are considered useful tools for the evaluation of solid pancreatic tumors (SPT). The aim of our study was to evaluate the diagnostic accuracy of CEH-EUS, QE-EUS, and the combination of both for the differential diagnosis of SPT., Methods: Sixty-two consecutive patients (mean age 64.3 years, range 32-89 years, 44 male) who underwent EUS for the evaluation of SPT were prospectively included. EUS was performed with a linear Pentax-EUS and a Hitachi-Preirus processor. The mass (area A) and a reference area B were selected during QE-EUS, and results expressed as B/A (strain ratio). A strain histogram of the mass was also evaluated. Microvascularization of the tumor was evaluated over 2 min during CEH-EUS after intravenous injection of 4.8 mL SonoVue. Final diagnosis was based on histopathology of surgical specimens or EUS-guided tissue acquisition and clinical follow-up in non-operated cases. Diagnostic accuracy of CEH-EUS, QE-EUS, and their combination was calculated., Results: Median size of the masses was 32 mm (range 12-111). Final diagnosis was pancreatic adenocarcinoma ( n  = 45), neuroendocrine tumor ( n  = 3), inflammatory mass ( n  = 10), pancreatic metastasis ( n  = 2), autoimmune pancreatitis ( n  = 1), and a mucinous cystadenocarcinoma ( n  = 1). Overall accuracies for determination of malignancy using QE-EUS, CEH-EUS, their combination, and EUS-guided tissue acquisition were 98.4% (95% confidence interval (CI): 91.4-99.7), 85.5% (95% CI: 74.7-92.2), 91.9% (95% CI: 82.5-96.5), and 91.5% (95% CI: 83.6-99.5), respectively., Conclusion: The combination of QE-EUS and CEH-EUS is a useful tool for the differential diagnosis of SPT, giving complementary information. However, this combination does not significantly increase the diagnostic accuracy of either of the techniques performed alone.

Background: Most patients with gastroesophageal reflux disease experience symptomatic relapse after stopping acid-suppressive medication. The aim of this study was to compare willingness to continue treatment with esomeprazole on-demand versus continuous maintenance therapy for symptom control in patients with non-erosive reflux disease (NERD) after 6 months., Methods: This multicenter, open-label, randomized, parallel-group study enrolled adults with NERD who were heartburn-free after 4 weeks' treatment with esomeprazole 20 mg daily. Patients received esomeprazole 20 mg daily continuously or on-demand for 6 months. The primary variable was discontinuation due to unsatisfactory treatment. On-demand treatment was considered non-inferior if the upper limit of the one-sided 95 % confidence interval (CI) for the difference between treatments was <10 %., Results: Of 877 patients enrolled, 598 were randomized to maintenance treatment (continuous: n = 297; on-demand: n = 301). Discontinuation due to unsatisfactory treatment was 6.3 % for on-demand and 9.8 % for continuous treatment (difference -3.5 % [90 % CI: -7.1 %, 0.2 %]). In total, 82.1 and 86.2 % of patients taking on-demand and continuous therapy, respectively, were satisfied with the treatment of heartburn and regurgitation symptoms, a secondary variable (P = NS). Mean study drug consumption was 0.41 and 0.91 tablets/day, respectively. Overall, 5 % of the on-demand group developed reflux esophagitis versus none in the continuous group (P < 0.0001). The Gastrointestinal Symptom Rating Scale Reflux dimension was also improved for continuous versus on-demand treatment. Esomeprazole was well tolerated., Conclusions: In terms of willingness to continue treatment, on-demand treatment with esomeprazole 20 mg was non-inferior to continuous maintenance treatment and reduced medication usage in patients with NERD who had achieved symptom control with initial esomeprazole treatment., Trial Registration: ClinicalTrials.gov identifier (NCT number): NCT02670642 ; Date of registration: December 2015.

Background and Goals: Predicting relapse in Inflammatory Bowel Disease (IBD) could allow for early changes of treatment. Close monitoring of fecal calprotectin (FC) could be useful to predict relapse in IBD. Aim of the study was to evaluate the predictive value of a rapid FC test to predict flares in patients with IBD under maintenance therapy with Infliximab., Study: A prospective observational cohort study was designed. IBD patients in clinical remission under maintenance Infliximab therapy were included. FC was measured using a rapid test on a stool sample obtained within 24 hours before Infliximab infusion. Clinical examination was performed 2 months after that infusion., Results: Fifty-three patients were included (52.8% female). Thirty-three patients (62.3%) had Crohn's disease and 20 (37.7%) had ulcerative colitis. All patients were in remission at inclusion. After 2 months, 41 patients (77.4%) remained in clinical remission and 12 (22.6%) presented a relapse. FC (mean±SD) in relapsing and not-relapsing disease was 332±168 and 110±163 µg/g, respectively (P<0.005). A FC concentration>160 µg/g had a sensitivity of 91.7%, and specificity of 82.9% to predict relapse., Conclusions: In IBD patients under Infliximab maintenance therapy, high FC levels allow predicting relapse within the following 2 months. Long-term remission is associated with low calprotectin levels. Further studies are required to confirm these results.

Background and Aim: Predicting relapse in Crohn's disease (CD) patients by measuring non-invasive biomarkers could allow for early changes of treatment. Data are scarce regarding the utility of monitoring calprotectin to predict relapse. The aim of the study was to evaluate the predictive value of a rapid test of faecal calprotectin (FC) to predict for flares in CD patients on maintenance treatment with adalimumab (ADA)., Methods: A prospective, observational cohort study was designed. Inclusion criteria were CD patients in clinical remission on a standard dose of ADA therapy. Fresh FC was measured using a rapid test., Results: Thirty patients were included (median age 38 years, 56.7% female). After the 4 months follow-up, 70.0% patients remained in clinical remission and 30.0% had a relapse. FC concentration at inclusion was significantly higher in those patients who relapsed during the follow-up (625 μg/g) compared to those who stayed in remission (45 μg/g). The optimal cut-off for FC to predict relapse was 204 μg/g. The area under the receiver-operating characteristic curve was 0.968. Sensitivity, specificity, positive, and negative predictive value of FC to predict relapse were 100%, 85.7%, 74.1%, and 100%, respectively., Conclusion: In CD patients on ADA maintenance therapy, FC levels measured with a rapid test allow relapse over the following months to be predicted with high accuracy. Low FC levels exclude relapse within at least 4 months after testing, whereas high levels are associated with relapse in three out of every four patients.

Background: Scanty data on the performance of the new 25-gauge Procore™ biopsy needle are available., Methods: Consecutive patients who underwent endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) using the 25G Procore™ were retrospectively retrieved. All samples were independently reviewed by 3 pathologists for the following: histological, cytological or no specimen, neoplasia, diagnostic or non-diagnostic. Diagnostic accuracy and inter-rater concordance among pathologists were calculated., Results: 94 patients underwent EUS-FNB of 101 sites (69 solid masses, 25 lymph nodes, 5 wall thickening). Forty-one biopsies (40.5%) were classified as histological samples by at least two pathologists, 29 as cytological (28.7%), 31 had no sample (30.7%). Good and almost perfect agreements among pathologists in defining cytological vs. histological samples (k 0.82; 95% CI: 0.74-0.90), diagnostic vs. non-diagnostic (k 0.95; 95% CI: 0.85-1.00) and neoplastic vs. non-neoplastic (k 0.94; 95% CI: 0.83-1.00). According to consensus rating, 61 cases were diagnostic samples (60.4%). Histological samples were more likely to lead to a correct diagnosis (OR, 4.1; 95% P=0.027), while neoplastic lesions were less likely to be correctly classified than benign (OR, 0.11; P=0.04)., Conclusions: EUS-FNB with the Procore™ 25G needle provided samples for histological examination in only 40% of the cases, with 31% of inadequate specimens, despite excellent results in term of inter-observer variability., (Copyright © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background and Objectives: Previous reports assessing the reproducibility of endoscopic ultrasound elastography (EUS-E) in evaluation of solid pancreatic lesions (SPL) involved only experienced endosonographers. We aimed to assess the interobserver agreement (IOA) of EUS-E in the evaluation of SPL by endoscopists with different levels of experience in EUS and EUS-E., Materials and Methods: A cross-sectional observational multicenter study was designed and included 11 endoscopists who were divided into four groups: Group A (long experience in EUS and EUS-E); Group B (short experience in EUS and EUS-E); Group C (long experience in EUS and no experience in EUS-E); and Group D (no experience in EUS or EUS-E). The observers independently classified the patterns of 60 video sequences of EUS-E, after a 20-min training session. For each group, we calculated IOA (kappa statistic, k) of EUS-E and the diagnostic accuracy of EUS-E for pancreatic malignancy, by comparing the pattern of EUS-E indicative of malignancy (heterogeneous or homogenous blue) with the final diagnosis., Results: The overall IOA was moderate (k = 0.42; 95% confidence interval (CI) 0.33-0.52). The IOA of Group A (k = 0.80; 95% CI 0.65-1.00) was significantly higher than that of Groups B (k = 0.54; 95%CI 0.40-0.71), C (k = 0.54; 95%CI 0.39-0.68), and D (k = 0.28; 95%CI 0.14-0.40). IOA of Groups B and C was not significantly different, but it was significantly higher than that of Group D. The diagnostic accuracy of Group A (area under the curve under summary receiver operating characteristic (AUROC) = 0.83; 95%CI 0.75-0.90) was not significantly different from that of Group B (AUROC = 0.77; 95%CI 0.71-0.83), but it was significantly higher than that of Groups C (AUROC = 0.74; 95%CI 0.67-0.81) and D (AUROC = 0.74; 95%CI 0.67-0.81). No significant difference was seen between Groups B, C, and D for diagnostic accuracy., Conclusion: EUS-E is reproducible in the evaluation of SPL, even between endoscopists with no or limited experience in EUS and/or EUS-E. Reproducibility and diagnostic accuracy increase with experience in EUS and EUS-E.

Background and Study Aims: Previous reports assessing the reproducibility of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) in the evaluation of solid pancreatic lesions (SPLs) involved mainly experienced endosonographers. We aimed to assess the interobserver agreement (IOA) of CH-EUS in the evaluation of SPLs by endoscopists with different levels of experience in EUS and CH-EUS., Participants and Methods: A cross-sectional observational multicenter study was designed and included 11 endoscopists who were divided into four groups according to their experience in EUS and CH-EUS: group A (long experience in EUS and CH-EUS); group B (short experience in EUS and CH-EUS); group C (long experience in EUS and no experience in CH-EUS); and group D (no experience in EUS or CH-EUS). The observers independently classified the patterns of 60 CH-EUS video sequences of 60 SPLs after a 20-minute training session. For each group, we calculated the IOA (kappa statistic, κ) of CH-EUS and the accuracy of CH-EUS for the diagnosis of pancreatic adenocarcinoma by comparing the pattern of CH-EUS indicative of pancreatic adenocarcinoma (hypo-enhanced contrast pattern) with the final diagnosis., Results: The overall IOA for CH-EUS was fair (κ = 0.32; 95 %CI 0.22 - 0.41). Group A (κ = 0.63; 95 %CI 0.45 - 0.85) had the highest IOA, followed by group C (κ = 0.54; 95 %CI 0.39 - 0.71), group B (κ = 0.38; 95 %CI 0.22 - 0.55), and group D (κ = 0.21; 95 %CI 0.07 - 0.36). The IOA of groups A and C was significantly higher than that of group D. No significant difference was seen between groups A, B, and C or between groups B and D in terms of IOA. Group A (area under the curve under summary receiver operating characteristic [AUROC] = 0.67; 95 %CI 0.58 - 0.75) had the highest accuracy for the diagnosis of pancreatic adenocarcinoma, followed by group C (AUROC = 0.58; 95 %CI 0.50 - 0.65), group B (AUROC = 0.55; 95 %CI 0.48 - 0.63), and group D (AUROC = 0.51; 95 %CI 0.43 - 0.58). The diagnostic accuracy of group A was not significantly different from that of group C, but it was significantly higher than that of groups B and D. No significant difference was seen between groups B, C, and D in terms of diagnostic accuracy., Conclusions: CH-EUS is reproducible in the evaluation of SPLs, even between endoscopists with no or limited experience in EUS and/or CH-EUS. Long experience in EUS is a major contributor to the IOA and diagnostic accuracy of CH-EUS.

Background: No single histopathological feature of submucosal invasive colorectal cancer (T1-CRC) can reliably predict the risk for lymph node metastasis (LNM)., Aim: The purpose of the study was to develop a prediction model of LNM in T1-CRC., Methods: Ninety-seven surgically resected T1-CRC at our institution were retrospectively evaluated. Morphology, localization, grading, mode of growth, presence of background adenoma, lymphoid infiltration, angiolymphatic invasion, budding, and depth of invasion were assessed. Mortality and morbidity related to surgery were also evaluated. Benefit-risk balance was assessed according to the presence of severe complications and to the presence of LNM., Results: Fourteen cases had LNM (14%). Eight patients (8%) presented severe surgical complications and there were two deaths (2 %). Infiltrative growth pattern (OR 31.91, 95% CI 2.37-428.36; p = 0.009) and the absence of lymphoid infiltrate (OR 28.75; 95% CI 2.13-388.37; p = 0.011) were the only variables independently associated with LNM in the multivariate analysis. Both variables were included in the prediction model together with sessile morphology (OR 4.88; 95% CI 0.81-29.3; p = 0.083) and poorly differentiated carcinoma (OR 11.77; 95% CI 0.77-179.83; p = 0.076). A 0-100 score was developed (infiltrative growth pattern: no = 0, yes = 33; lymphoid infiltrate: no = 29, yes = 0; sessile morphology: no = 0, yes = 15; poorly differentiated: no = 0, yes = 23). Cutoff point to indicate additional surgery was set in 35 points (i.e., 10% risk LNM). Discrimination of the prediction model was excellent (AUC 0.90; 95% CI 0.81-0.99)., Conclusion: Combined evaluation of infiltrative growth pattern, lymphoid infiltration, poorly differentiated carcinoma, and sessile appearance showed good performance for discriminating T1-CRC patients with LNM. The benefit-risk balance was in favor of surgery when at least two of these criteria were present.

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: 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.

Background: A higher incidence of inflammatory bowel disease (IBD) in industrialized areas has been previously reported, but the effect of emigrating to western industrialized countries for a period of time and returning to the country of origin is unknown. Aim of the study was to evaluate the effect of emigrating to another country and returning to the place of origin on the risk of IBD., Methods: A prospective case-control study was performed. Inclusion criteria were all patients >18 years diagnosed with Crohn's disease (CD) or ulcerative colitis (UC) in the last 10 years. Healthy, unrelated controls, matched by sex, age and smoking habits, with no family history of IBD were included. All patients and controls were interviewed and emigration was defined as living for at least one year in another country., Results: 242 consecutive patients with IBD (105 CD and 137 UC) and 242 controls were included. Patients who had previously emigrated developed more frequently IBD than controls (OR 1.93, 95%CI 1.19-3.15, p<0.01). Patients who emigrated to European countries developed more frequently IBD than controls (OR 1.91, 95%CI 1.07-3.47, p=0.02), but not those who had emigrated to Latin America (OR 1.48, 95%CI 0.67-3.27, p=0.32). Emigration plays a significant role in the development of UC (OR 2.24, 95%CI:1.29-3.88, p<0.01), but not in CD (OR 1.56, 95%IC:0.83-2.92, p=0.15)., Conclusions: People who emigrate to westernised countries have a higher risk for developing IBD, especially UC. Environmental factors related with industrialization seem to play an important role in the pathogenesis of these diseases., (Copyright © 2011 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.)

Pancreatic cancer (PC) is considered as one of the malignant tumors with poorest survival rate (less than 5% 5-year survival). Despite new developments in imaging techniques, surgery and oncologic treatments, survival rate remains unchanged. In order to improve the outcome of this disease, it would be of interest the development of a screening program trying to detect small asymptomatic tumors or precursor lesions at the time when the disease is still at a curable stage. Although screening in general population is not feasible nowadays, screening programs in high risk individuals may be of help in this setting. A specific population has been defined to be screened, those with a >10-fold increased risk for developing the disease (inherited PC syndromes due to inherited gene mutations and individuals with a strong family history of PC with at least 2 first-degree relatives affected, but without a known genetic defect). Regarding the methods for screening, endoscopic ultrasound (EUS) and magnetic resonance imaging (MRI) appears to be the most accurate, mainly based in their ability to detect those small pancreatic tumors and precursor lesions (like IPMN and PanIN lesions). In these patients screening should start at the age of 45, or 15 years earlier than the earliest occurrence of PC in the family, whichever is the earlier age. Explorations should be schedule every 1 to 3 years, depending on initial findings.

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.)