Publications by authors named "Juan Vila"

76 Publications

Characteristics of patients with chronic hypoparathyroidism not adequately controlled with conventional treatment and management patterns in Spain.

Endocrinol Diabetes Nutr (Engl Ed) 2021 May 6;68(5):304-311. Epub 2021 Sep 6.

Shire Pharmaceuticals Ibérica SL, miembro del grupo empresarial Takeda, Madrid, Spain. Electronic address:

Background And Objective: The current guidelines on hypoparathyroidism offer a model for treating patients but do not cover real-world situations or patient diversity. Given the lack of data regarding hypoparathyroidism, a Delphi panel was convened in Spain to establish consensus in defining the characteristics of patients with chronic hypoparathyroidism not adequately controlled with conventional treatment, as well as to investigate patterns of management.

Material And Methods: A presentation matrix provided a framework for characterizing inadequately controlled chronic hypoparathyroidism, based on four predefined patient groups: group 1 (normal biochemical levels and the patient feeling well); group 2 (abnormal biochemical levels and the patient feeling well); group 3 (normal biochemical levels and the patient feeling unwell); and group 4 (abnormal biochemical levels and the patient feeling unwell). Based on Likert scales (scored 1-9), the experts were asked to state their agreement/disagreement with the characteristics of patients with chronic hypoparathyroidism, including demographic data, family history, comorbidities, biochemical values, symptoms and quality of life. Consensus was achieved when ≥66% of the respondents were in agreement.

Results: Consensus was achieved on the importance of assessing demographic data and comorbidities (e.g., renal complications) in groups 2, 3 and 4; family medical history in groups 2 and 3; biochemical parameters (e.g., calcemia/urinary calcium excretion) in groups 2 and 4; and clinical symptoms and quality of life in groups 3 and 4. Consensus was also reached regarding the maintenance of several biochemical parameters and the need for personalized treatment and training in symptoms and complications.

Conclusions: The Spanish expert panel reached consensus defining key disease parameters and factors of importance for characterizing and treating patients with inadequately controlled chronic hypoparathyroidism.
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http://dx.doi.org/10.1016/j.endien.2021.08.008DOI Listing
May 2021

Cricopharyngeal peroral endoscopic myotomy for achalasia of the cricopharynx: "to do or not to do".

Endoscopy 2021 Aug 9. Epub 2021 Aug 9.

Endoscopy Unit, Gastroenterology Department, Complejo Hospitalario de Navarra, Pamplona, Spain.

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http://dx.doi.org/10.1055/a-1544-7677DOI Listing
August 2021

Curriculum for ERCP and endoscopic ultrasound training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

Endoscopy 2021 Oct 26;53(10):1071-1087. Epub 2021 Jul 26.

Department of Gastroenterology and Hepatology, University Hospitals Leuven, and TARGID, KU Leuven, Leuven, Belgium.

The European Society of Gastrointestinal Endoscopy (ESGE) has recognized the need to formalize and enhance training in endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS). This manuscript represents the outcome of a formal Delphi process resulting in an official Position Statement of the ESGE and provides a framework to develop and maintain skills in ERCP and EUS. This curriculum is set out in terms of the prerequisites prior to training; recommended steps of training to a defined syllabus; the quality of training; and how competence should be defined and evidenced before independent practice. 1: Trainees should be competent in gastroscopy prior to commencing training. Formal training courses and the use of simulation in training are recommended. 2: Trainees should keep a contemporaneous logbook of their procedures, including key performance indicators and the degree of independence. Structured formative assessment is encouraged to enhance feedback. There should be a summative assessment process prior to commencing independent practice to ensure there is robust evidence of competence. This evidence should include a review of a trainee's procedure volume and current performance measures. A period of mentoring is strongly recommended in the early stages of independent practice. 3: Specifically for ERCP, all trainees should be competent up to Schutz level 2 complexity (management of distal biliary strictures and stones > 10 mm), with advanced ERCP requiring a further period of training. Prior to independent practice, ESGE recommends that a trainee can evidence a procedure volume of > 300 cases, a native papilla cannulation rate of ≥ 80 % (90 % after a period of mentored independent practice), complete stones clearance of ≥ 85 %, and successful stenting of distal biliary strictures of ≥ 90 % (90 % and 95 % respectively after a mentored period of independent practice). 4: The progression of EUS training and competence attainment should start from diagnostic EUS and then proceed to basic therapeutic EUS, and finally to advanced therapeutic EUS. Before independent practice, ESGE recommends that a trainee can evidence a procedure volume of > 250 cases (75 fine-needle aspirations/biopsies [FNA/FNBs]), satisfactory visualization of key anatomical landmarks in ≥ 90 % of cases, and an FNA/FNB accuracy rate of ≥ 85 %. ESGE recognizes the often inadequate quality of the evidence and the need for further studies pertaining to training in advanced endoscopy, particularly in relation to therapeutic EUS.
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http://dx.doi.org/10.1055/a-1537-8999DOI Listing
October 2021

Next-generation sequencing of bile cell-free DNA for the early detection of patients with malignant biliary strictures.

Gut 2021 Jul 20. Epub 2021 Jul 20.

Navarra Institute for Health Research, IdiSNA, Pamplona, Spain.

Objective: Despite significant progresses in imaging and pathological evaluation, early differentiation between benign and malignant biliary strictures remains challenging. Endoscopic retrograde cholangiopancreatography (ERCP) is used to investigate biliary strictures, enabling the collection of bile. We tested the diagnostic potential of next-generation sequencing (NGS) mutational analysis of bile cell-free DNA (cfDNA).

Design: A prospective cohort of patients with suspicious biliary strictures (n=68) was studied. The performance of initial pathological diagnosis was compared with that of the mutational analysis of bile cfDNA collected at the time of first ERCP using an NGS panel open to clinical laboratory implementation, the Oncomine Pan-Cancer Cell-Free assay.

Results: An initial pathological diagnosis classified these strictures as of benign (n=26), indeterminate (n=9) or malignant (n=33) origin. Sensitivity and specificity of this diagnosis were 60% and 100%, respectively, as on follow-up 14 of the 26 and eight of the nine initially benign or indeterminate strictures resulted malignant. Sensitivity and specificity for malignancy of our NGS assay, herein named Bilemut, were 96.4% and 69.2%, respectively. Importantly, one of the four Bilemut false positives developed pancreatic cancer after extended follow-up. Remarkably, the sensitivity for malignancy of Bilemut was 100% in patients with an initial diagnosis of benign or indeterminate strictures. Analysis of 30 paired bile and tissue samples also demonstrated the superior performance of Bilemut.

Conclusion: Implementation of Bilemut at the initial diagnostic stage for biliary strictures can significantly improve detection of malignancy, reduce delays in the clinical management of patients and assist in selecting patients for targeted therapies.
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http://dx.doi.org/10.1136/gutjnl-2021-325178DOI Listing
July 2021

Diagnostic accuracy and interobserver agreement of digital single-operator cholangioscopy for indeterminate biliary strictures.

Gastrointest Endosc 2021 Jul 1. Epub 2021 Jul 1.

Department of Gastroenterology, University College London Hospitals, London, UK; Sheila Sherlock Liver Centre, Royal Free Hospital, London, UK.

Background And Aims: Digital single-operator cholangioscopy (d-SOC) with cholangioscopic biopsy sampling has shown promise in the evaluation of indeterminate biliary strictures. Some studies have suggested higher sensitivity for visual impression compared with biopsy sampling, although assessors were not blinded to previous investigations. We aimed to investigate the diagnostic accuracy and interobserver agreement (IOA) of d-SOC in the visual appraisal of biliary strictures when blinded to additional information.

Methods: A multicenter, international cohort study was performed. Cholangioscopic videos in patients with a known final diagnosis were systematically scored. Pseudonymized videos were reviewed by 19 experts in 2 steps: blinded for patient history and investigations and unblinded.

Results: Forty-four high-quality videos were reviewed of 19 benign and 25 malignant strictures. The sensitivity and specificity for the diagnosis of malignancy was 74.2% and 46.9% (blinded) and 72.7% and 62.5% (unblinded). Cholangioscopic certainty of a malignant diagnosis led to overdiagnosis (sensitivity, 90.6%; specificity, 33%), especially if no additional information was provided. The IOA for the presence of malignancy was fair for both assessments (Fleiss' κ = .245 [blinded] and κ = .321 [unblended]). For individual visual features, the IOA ranged from slight to moderate for both assessments (κ = .059-.400 vs κ = .031-.452).

Conclusions: This study showed low sensitivity and specificity for blinded and unblinded d-SOC video appraisal of indeterminate biliary strictures, with considerable interobserver variation. Although reaching a consensus on the optical features of biliary strictures remains important, optimizing visually directed biopsy sampling may be the most important role of cholangioscopy in biliary stricture assessment.
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http://dx.doi.org/10.1016/j.gie.2021.06.027DOI Listing
July 2021

Endoscopic ultrasound-guided rendezvous for extrahepatic bile duct recanalization after surgical transection.

Endoscopy 2021 Apr 28. Epub 2021 Apr 28.

Endoscopy Unit, Gastroenterology Department, Complejo Hospitalario de Navarra, Pamplona, Spain.

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http://dx.doi.org/10.1055/a-1471-1685DOI Listing
April 2021

Characteristics of patients with chronic hypoparathyroidism not adequately controlled with conventional treatment and management patterns in Spain.

Endocrinol Diabetes Nutr (Engl Ed) 2021 May 10;68(5):304-311. Epub 2021 Feb 10.

Shire Pharmaceuticals Ibérica SL, miembro del grupo empresarial Takeda, Madrid, España. Electronic address:

Background And Objective: The current guidelines on hypoparathyroidism offer a model for treating patients but do not cover real-world situations or patient diversity. Given the lack of data regarding hypoparathyroidism, a Delphi panel was convened in Spain to establish consensus in defining the characteristics of patients with chronic hypoparathyroidism not adequately controlled with conventional treatment, as well as to investigate patterns of management.

Material And Methods: A presentation matrix provided a framework for characterizing inadequately controlled chronic hypoparathyroidism, based on 4 predefined patient groups: group 1 (normal biochemical levels and the patient feeling well); group 2 (abnormal biochemical levels and the patient feeling well); group 3 (normal biochemical levels and the patient feeling unwell); and group 4 (abnormal biochemical levels and the patient feeling unwell). Based on Likert scales (scored 1-9), the experts were asked to state their agreement / disagreement with the characteristics of patients with chronic hypoparathyroidism, including demographic data, family history, comorbidities, biochemical values, symptoms and quality of life. Consensus was achieved when ≥ 66% of the respondents were in agreement.

Results: Consensus was achieved on the importance of assessing demographic data and comorbidities (e.g., renal complications) in groups 2, 3 and 4; family medical history in groups 2 and 3; biochemical parameters (e.g., calcemia / urinary calcium excretion) in groups 2 and 4; and clinical symptoms and quality of life in groups 3 and 4. Consensus was also reached regarding the maintenance of several biochemical parameters and the need for personalized treatment and training in symptoms and complications.

Conclusions: The Spanish expert panel reached consensus defining key disease parameters and factors of importance for characterizing and treating patients with inadequately controlled chronic hypoparathyroidism.
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http://dx.doi.org/10.1016/j.endinu.2020.10.008DOI Listing
May 2021

EUS and ERCP: A rationale categorization of a productive partnership.

Endosc Ultrasound 2021 Jan-Feb;10(1):25-32

Department of Gastroenterology, Endoscopy Unit, Complejo Hospitalario de Navarra, Pamplona, Spain.

ERCP and EUS are complementary techniques in the management of biliary and pancreatic diseases. Combination of these two techniques can reach different levels of complexity with increasing rates of adverse events. In this article we propose a categorization of the relationship between EUS and ERCP based on whether EUS indicates, complements, facilitates or replaces ERCP. It has implications for the complexity of the technique, the training of the endoscopist and the necessary hospital resources. This classification can also be useful in planning endoscopist training and patient management.
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http://dx.doi.org/10.4103/eus.eus_58_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7980694PMC
December 2020

CHOLANGIOPANCREATOSCOPY. WORKING PROTOCOL. SEED Recommendations.

Rev Esp Enferm Dig 2021 Mar;113(3):207-214

Endoscopia Digestiva, Hospital Universitari Arnau de Vilanova, España.

Direct endoscopic visualization of biliary and pancreatic ducts represents one step further in the journey of digestive endoscopy. It allows the identification of lesions that were previously attainable through indirect means. Directed biopsy taking has permitted a better characterization of the lesions. The use of power sources through the cholangiopancreatoscope means that it is now possible to fragment and remove refractory lithiases using traditional endoscopic systems. This document aims to define the advisable workflow when using a single-use, flexible cholangiopancreatoscope with the commercial name of SpyGlass®. Penning a set of guidelines to provide instructions on the technique, as well as tips and tricks related with the operation of these endoscopes will be a useful resource.
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http://dx.doi.org/10.17235/reed.2020.7531/2020DOI Listing
March 2021

Endoscopic management of local complications of chronic pancreatitis.

Rev Esp Enferm Dig 2021 Aug;113(8):602-609

Aparato Digestivo, Complejo Hospitalario de Navarra, España.

Endoscopic treatment of local complications in patients with chronic pancreatitis has gained ground over the surgical alternative in the last few years. The lower aggressiveness of endoscopic treatment, as well as the possibility to use it repeatedly in high-risk patients, has favored this development. In addition, the incorporation of new, highly accurate endoscopic therapeutic options such as pancreatoscopy-guided lithotripsy and endoscopic ultrasound-guided treatments make endoscopic treatment the first choice in many cases, despite discordant data in the literature. This article reviews the endoscopic treatment of the most common local complications of chronic pancreatitis, such as pancreatolithiasis, pseudocysts, and pancreatic, biliary, and duodenal ductal stenosis.
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http://dx.doi.org/10.17235/reed.2020.7372/2020DOI Listing
August 2021

EUS is superior to secretin-enhanced cholangio-MRI to establish the etiology of idiopathic acute pancreatitis.

Endosc Int Open 2020 Oct 7;8(10):E1441-E1447. Epub 2020 Oct 7.

Endoscopy Unit, Gastroenterology Dpt, Complejo Hospitalario de Navarra, Pamplona, Spain.

The etiology of idiopathic acute pancreatitis (IAP) should always be defined. Our aim was to compare the diagnostic value of endoscopic ultrasound (EUS) versus secretin-enhanced magnetic resonance cholangiopancreatography (S-MRCP) in patients with IAP. Patients admitted to a single tertiary care University hospital with IAP were invited to participate in the study. Enrolled patients underwent EUS and S-MRCP in a single-blinded comparative study. EUS and S-MRCP were performed no sooner than 4 weeks after discharge. The diagnostic yield of EUS and S-MRCP and demographic variables were included in the analysis. Additional follow-up, results of subsequent serology, radiographic exams, and relevant histological analysis were considered in determination of the final diagnosis. A total of 34 patients were enrolled; EUS was normal in six, cholelithiasis was defined in 15, choledocholithiasis in two, pancreas divisum in three, branch-type intraductal papillary mucinous tumor (IPMT) in three, and chronic pancreatitis in five. S-MRCP identified choledocholithiasis in one, divisum in four, branch-type IPMT in three, chronic pancreatitis in two; 24 subjects diagnosed as normal by S-MRCP. Diagnostic correlation between EUS and S-MRCP was slight (kappa = 0.236, 95 % confidence interval: 0.055-0.416). EUS provided a statistically significantly higher diagnostic yield than S-MRCP: 79.4 % (CI95 %: 65 %-94 %) vs 29.4 % (CI95 %: 13 %-46 %) (P = 0.0002). The sensitivity, specificity, and positive and negative predictive values of EUS and S-MRCP were 90 %, 80 %, 96 %, 57 % and 33 %, 100 %, 100 % and 16 %, respectively. The diagnostic yield of EUS is higher than S-MRCP in patients with IAP.
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http://dx.doi.org/10.1055/a-1233-1849DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7541189PMC
October 2020

An international, multi-institution survey on performing EUS-FNA and fine needle biopsy.

Endosc Ultrasound 2020 Sep-Oct;9(5):319-328

Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.

Background And Objectives: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) and fine needle biopsy (FNB) are effective techniques that are widely used for tissue acquisition. However, it remains unclear how to obtain high-quality specimens. Therefore, we conducted a survey of EUS-FNA and FNB techniques to determine practice patterns worldwide and to develop strong recommendations based on the experience of experts in the field.

Methods: This was a worldwide multi-institutional survey among members of the International Society of EUS Task Force (ISEUS-TF). The survey was administered by E-mail through the SurveyMonkey website. In some cases, percentage agreement with some statements was calculated; in others, the options with the greatest numbers of responses were summarized. Another questionnaire about the level of recommendation was designed to assess the respondents' answers.

Results: ISEUS-TF members developed a questionnaire containing 17 questions that was sent to 53 experts. Thirty-five experts completed the survey within the specified period. Among them, 40% and 54.3% performed 50-200 and more than 200 EUS sampling procedures annually, respectively. Some practice patterns regarding FNA/FNB were recommended.

Conclusion: This is the first worldwide survey of EUS-FNA and FNB practice patterns. The results showed wide variations in practice patterns. Randomized studies are urgently needed to establish the best approach for optimizing the FNA/FNB procedures.
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http://dx.doi.org/10.4103/eus.eus_56_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7811723PMC
September 2020

Pilot Multi-Omic Analysis of Human Bile from Benign and Malignant Biliary Strictures: A Machine-Learning Approach.

Cancers (Basel) 2020 Jun 21;12(6). Epub 2020 Jun 21.

National Institute for the Study of Liver and Gastrointestinal Diseases, CIBERehd, Carlos III Health Institute, 28029 Madrid, Spain.

Cholangiocarcinoma (CCA) and pancreatic adenocarcinoma (PDAC) may lead to the development of extrahepatic obstructive cholestasis. However, biliary stenoses can also be caused by benign conditions, and the identification of their etiology still remains a clinical challenge. We performed metabolomic and proteomic analyses of bile from patients with benign ( = 36) and malignant conditions, CCA ( = 36) or PDAC ( = 57), undergoing endoscopic retrograde cholangiopancreatography with the aim of characterizing bile composition in biliopancreatic disease and identifying biomarkers for the differential diagnosis of biliary strictures. Comprehensive analyses of lipids, bile acids and small molecules were carried out using mass spectrometry (MS) and nuclear magnetic resonance spectroscopy (H-NMR) in all patients. MS analysis of bile proteome was performed in five patients per group. We implemented artificial intelligence tools for the selection of biomarkers and algorithms with predictive capacity. Our machine-learning pipeline included the generation of synthetic data with properties of real data, the selection of potential biomarkers (metabolites or proteins) and their analysis with neural networks (NN). Selected biomarkers were then validated with real data. We identified panels of lipids ( = 10) and proteins ( = 5) that when analyzed with NN algorithms discriminated between patients with and without cancer with an unprecedented accuracy.
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http://dx.doi.org/10.3390/cancers12061644DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7352944PMC
June 2020

Biliary hitch and ride technique for blind pancreatic duct cannulation.

Endoscopy 2021 Jan 29;53(1):E29-E30. Epub 2020 May 29.

Endoscopy Unit, Gastroenterology Department, Complejo Hospitalario de Navarra, Pamplona, Spain.

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http://dx.doi.org/10.1055/a-1173-7910DOI Listing
January 2021

The safety and efficacy of a new 20-mm lumen apposing metal stent (lams) for the endoscopic treatment of pancreatic and peripancreatic fluid collections: a large international, multicenter study.

Surg Endosc 2021 04 22;35(4):1741-1748. Epub 2020 Apr 22.

Department of Surgical Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.

Background: Lumen apposing metal stent (LAMS) allows an easy access to peripancreatic fluid collections (PPFCs) and the possibility of performing direct endoscopic necrosectomy (DEN). The aim of our study was to evaluate the safety and efficacy of a new 20-mm LAMS in the management of PPFCs. This novel stent represents the largest diameter LAMS available on the market to date.

Methods: This is an international, multicenter retrospective study involving 20 centers. Consecutive patients who underwent EUS-guided PPFC drainage using a 20-mm LAMS were included. Primary outcomes were technical and clinical success. Secondary outcomes were rate and the severity of adverse events.

Results: A total 105 patients underwent PPFC drainage using the new 20-mm LAMS and 106 LAMS were placed. Technical success was 100% (106/106). 7/105 patients died due to causes not related to the stent. Clinical success was achieved in 92/98 patients (93.9%). Significant adverse events occurred in 8/98 patients (8.16%): 4 cases (4.08%) of bleeding, 3 cases (3.06%) of suprainfection, 1 case of gastric outlet obstruction.

Conclusions: This multicenter study demonstrated acceptable rates of technical and clinical success using a new 20-mm LAMS for PPFC, including walled-off pancreatic necrosis (WOPN). The results of our study suggest that a new 20-mm LAMS is non-inferior in terms of safety, efficacy, and adverse events as compared to smaller diameter LAMS in the management of PPFCs, including pancreatic psuedocysts (PP) and WOPN. Randomized controlled studies will be needed to determine the ideal size of LAMS need to achieve the greatest clinical benefit with the minimized risk exposure for this high-risk patient population.
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http://dx.doi.org/10.1007/s00464-020-07567-8DOI Listing
April 2021

Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis - PROMETHEUS: a randomized controlled trial protocol.

Trials 2019 Dec 30;20(1):791. Epub 2019 Dec 30.

Clinical Research and Clinical Trial Unit (UICEC IDIBELL), Plataforma SCRen, Clinical Pharmacology Department, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Barcelona, Catalonia, Spain.

Background: It seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON). To date, there is no quality of evidence to recommend LAMS as the standard treatment in the management of WON. The theoretical benefit of LAMS over plastic stents needs to be proven.

Methods/design: This is a randomized controlled, multicenter, prospective clinical trial with two parallel groups, without masking. One-hundred and fourteen patients with WON will undergo endoscopic ultrasound (EUS)-guided transmural draining in nine tertiary hospitals in Spain and will be randomized to the LAMS or plastic-stent group. The primary endpoint is the short-term (4 weeks) clinical success determined by the reduction of the collection (to < 50% or < 5 cm in size), along with clinical improvement. Secondary endpoints: long-term (4 months) clinical success (total resolution or 5 cm), procedure duration, level of difficulty, safety, and recurrences.

Discussion: The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON.

Trial Registration: ClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home.
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http://dx.doi.org/10.1186/s13063-019-3988-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6937819PMC
December 2019

Defining the Characteristics of Chronic Hypoparathyroidism Not Adequately Controlled on Conventional Therapy: Consensus Findings of Three European Delphi Panels.

Adv Ther 2019 11 5;36(11):3007-3016. Epub 2019 Oct 5.

Shire International GmbH, a member of the Takeda group of companies, Zug, Switzerland.

Introduction: European Society of Endocrinology (ESE) guidelines provide goals for hypoparathyroidism management but do not define characteristics of chronic hypoparathyroidism that is not adequately controlled. Three European country-specific Delphi panels were conducted to gain consensus on these characteristics.

Methods: Delphi panels were conducted in the UK, Sweden, and Portugal using similar methodology. At each round, panellists considered patients with chronic hypoparathyroidism whose disease is not adequately controlled on conventional therapy according to a matrix of four presentations of patients with chronic hypoparathyroidism: normal biochemical levels/well (group 1), abnormal biochemical levels/well (group 2), normal biochemical levels/unwell (group 3), and abnormal biochemical levels/unwell (group 4), with wellness defined by the patient's persistent symptoms, comorbidities, and complications. For groups 2-4, panellists rated characteristics in five categories (patient characteristics, family history, comorbidities, biochemistry, and symptoms/impact on quality of life [QoL]) with respect to defining a patient as having chronic hypoparathyroidism that was not adequately controlled on conventional therapy. Consensus was achieved when more than 80% of respondents agreed.

Results: Among the three countries, panellists agreed that characteristics within four of the five categories (patient characteristics, comorbidities, biochemistry, and symptoms/impact on QoL) were important for defining inadequate control. Characteristics deemed important in groups 2-4 included a history of compliance problems and chronic kidney disease stages 4 and 5. In groups 2 and 4, the biochemical parameters deemed important were serum calcium, urinary calcium, and serum creatinine. In groups 3 and 4, tingling or numbness in the hands/feet and face was the only symptom deemed important in all three countries.

Conclusion: Delphi panels conducted in three European countries provided national consensus on key parameters of patient characteristics, biochemistry, comorbidities, and symptoms/impact on QoL that define not adequately controlled chronic hypoparathyroidism. These characteristics should be tested more widely for their applicability in clinical practice.

Funding: Shire International GmbH, Zug, Switzerland, a member of the Takeda group of companies.
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http://dx.doi.org/10.1007/s12325-019-01102-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6830839PMC
November 2019

The underutilization of EUS-guided biliary drainage: Perception of endoscopists in the East and West.

Endosc Ultrasound 2019 May-Jun;8(3):188-193

Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.

Background And Objectives: EUS-guided biliary drainage (EUS-BD) is increasingly utilized to manage unresectable malignant biliary obstruction after a failed ERCP. However, there is no data on how endoscopists perceive EUS-BD. The aim of this study was to investigate the perception of endoscopists on EUS-BD.

Patients And Methods: A survey questionnaire of six topics with 22 survey statements was developed. A total of 17 pancreatobiliary endoscopists (10 from East and 7 from West) were invited to survey. The participants were asked to answer the multiple choice questionnaire and give comments. The opinions of the participants for individual survey statements were assessed using 5-point Likert scale.

Results: All participants completed the survey. The endoscopists had a trend to perceive EUS-BD as a procedure indicated after a failed ERCP. Various EUS-BD methods were regarded as having different efficacy and safety. The superiority of EUS-BD over percutaneous transhepatic BD (PTBD) with regard to efficacy, procedure-related adverse events, and unscheduled re-intervention was not in agreement.

Conclusions: EUS-BD was not yet perceived as the initial procedure to relieve the unresectable malignant biliary obstruction. Various EUS-BD methods were regarded as having different efficacy and safety. The superiority of EUS-BD over PTBD was not in agreement. Refining the procedure, developing dedicated devices, and gaining expertise in the procedure are necessary to popularize EUS-BD.
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http://dx.doi.org/10.4103/eus.eus_57_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6590002PMC
February 2019

Risk of advanced lesions in patients with branch-duct IPMN and relative indications for surgery according to European evidence-based guidelines.

Dig Liver Dis 2019 06 10;51(6):882-886. Epub 2018 Dec 10.

Department of Gastroenterology and Hepatology, University Hospitals St-Luc, Brussels, Belgium.

Background: European evidence-based guidelines proposed surgery for branch-duct intraductal papillary mucinous neoplasms (BD-IPMNs) based on the presence of 1-2 relative indications, depending on the comorbidity burden.

Aims: To assess the accuracy of the guidelines in patients with relative indications in a surgical cohort of demonstrated BD-IPMNs.

Methods: This report describes a multi-centre, observational, retrospective study. All consecutive patients with relative indications and histologically confirmed BD-IPMN were included. The main outcome was risk of invasive carcinoma in patients with relative indications.

Results: Ninety-one patients with BD-IPMN underwent surgery because of absolute (n = 21), relative (n = 60), or no formal indications (n = 10). In total, there were 60 patients (mean age: 66 ± 9, 50% male) with one (n = 35, 58.3%) or ≥2 relative indications (n = 25, 41.7%). The global advanced lesion and invasive carcinoma rates were 40% and 13.3%, respectively. No risk factor was associated with high-grade dysplasia or invasive carcinoma. Patients with one indication had a lower risk of invasive carcinoma than did those with ≥2 relative indications (5.7% vs. 24%, respectively, p = 0.048); however, the advanced lesion rates were comparable (37.1% vs. 44%, p = 0.593).

Conclusions: Invasive carcinoma is considerably more frequent in patients with two or more relative indications. The surgical strategy in these selected cases should be decided on an individual basis.
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http://dx.doi.org/10.1016/j.dld.2018.11.028DOI Listing
June 2019

A multi-institution consensus on how to perform EUS-guided biliary drainage for malignant biliary obstruction.

Endosc Ultrasound 2018 Nov-Dec;7(6):356-365

Department of Endoscopy, Yokohama City University School of Medicine, Yokohama, Japan.

Background And Objectives: EUS-guided biliary drainage (EUS-BD) was shown to be useful for malignant biliary obstruction (MBO). However, there is lack of consensus on how EUS-BD should be performed.

Methods: This was a worldwide multi-institutional survey among members of the International Society of EUS conducted in February 2018. The survey consisted of 10 questions related to the practice of EUS-BD.

Results: Forty-six endoscopists of them completed the survey. The majority of endoscopists felt that EUS-BD could replace percutaneous transhepatic biliary drainage after failure of ERCP. Among all EUS-BD methods, the rendezvous stenting technique should be the first choice. Self-expandable metal stents (SEMSs) were recommended by most endoscopists. For EUS-guided hepaticogastrostomy (HGS), superiority of partially-covered SEMS over fully-covered SEMS was not in agreement. 6-Fr cystotomes were recommended for fistula creation. During the HGS approach, longer SEMS (8 or 10 cm) was recommended. During the choledochoduodenostomy approach, 6-cm SEMS was recommended. During the intrahepatic (IH) approach, the IH segment 3 was recommended.

Conclusion: This is the first worldwide survey on the practice of EUS-BD for MBO. There were wide variations in practice, and randomized studies are urgently needed to establish the best approach for the management of this condition.
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http://dx.doi.org/10.4103/eus.eus_53_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6289007PMC
December 2018

Esophageal leaks: I thought that glue was not effective.

Endosc Int Open 2018 Sep 11;6(9):E1100-E1102. Epub 2018 Sep 11.

Complejo Hospitalario de Navarra - Gastroenterology, Pamplona, Navarra, Spain.

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http://dx.doi.org/10.1055/a-0599-6288DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6177336PMC
September 2018

Acute Pancreatitis History Carries Higher Risk in Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Pancreatic Lesions.

Pancreas 2018 08;47(7):e38-e40

Department of Medicine and Geriatrics Tuen Mun Hospital Hong Kong SAR, China Endoscopy Unit Complejo Hospitalario de Navarra Pamplona, Spain.

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http://dx.doi.org/10.1097/MPA.0000000000001093DOI Listing
August 2018

Endoscopic Cauterization with Pneumatic Distension for Piriform Fossa Sinus Tracts.

J Laparoendosc Adv Surg Tech A 2018 Jul 3;28(7):880-883. Epub 2018 May 3.

1 University and Polytechnic La Fe Hospital , Valencia, Spain .

Introduction: Piriform fossa sinus tracts (PFSTs) are a cause of recurrent neck infections in the pediatric population. Conventional management required open resection, but over the last years minimally invasive approaches have been reported in an attempt to endoscopically obliterate the PFST, using different methods such as electrocautery, laser, trichloroacetic acid, or silver nitrate.

Materials And Methods: We undertook a retrospective review of the medical records of 12 children (aged 4 months to 14 years) with PFSTs treated with endoscopic sclerosis with diathermy (ESD) between 2010 and 2016 at a tertiary care children's hospital. We also present a technical modification of ESD, using continuous infusion of airflow through the gastroscopy, to distend the piriform sinus and facilitate its recognition. PFST obliteration was performed using diathermy through a guide wire.

Results: Clinical presentation of the 12 affected children included neck tumor (7 [58%]), neck abscesses (4 [33%]), and thyroiditis (5 [41%]). All lesions occurred on the left side. All patients underwent both ultrasonography and barium esophagography (the latter being positive only in 50%). Two patients were treated with ESD after the open approach had failed. There was no procedure-related morbidity. One patient had a recurrence (positive barium swallow without symptoms). The success rate of this procedure in our series was 91% with one attempt and 100% with two attempts.

Conclusion: In our experience, treatment of PFST with ESD is a reproducible, noninvasive, and an effective option. ESD could be considered a primary approach and also for revision after open surgery has failed in these patients.
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http://dx.doi.org/10.1089/lap.2017.0286DOI Listing
July 2018

Endoscopic ultrasound cytologic brushing vs endoscopic ultrasound - fine needle aspiration for cytological diagnosis of cystic pancreatic lesions. A multicenter, randomized open-label trial.

Rev Esp Enferm Dig 2018 Aug;110(8):478-484

Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Spain.

Introduction: the incidence of cystic pancreatic lesions (CPL) in the asymptomatic population is increasing. Achieving a preoperative diagnosis of CPL still remains a challenge.

Objectives: to evaluate the diagnostic accuracy of the cytological diagnosis of CPL from samples obtained by cytology brush versus standard endoscopic ultrasound fine needle aspiration (EUS-FNA).

Methods: a multicenter, randomized, open-label trial was performed of EUS-cytology brush (EUS-EB) versus EUS-FNA for the cytological diagnosis of CPL. Patients that underwent EUS-FNA with a CPL > 15 mm were included and randomized into two groups: group I, EUS-EB; group II, EUS-FNA. The final diagnosis was based on the histological evaluation of surgical specimens and clinical parameters, imaging and a five year follow-up in non-operated patients. The main outcome was the diagnostic accuracy of both methods. Secondary outcomes were the diagnostic adequacy of specimens and the rate of adverse events. Data were compared using the Chi-squared test. An intention to treat (ITT) and per-protocol (PP) analysis were performed.

Results: sixty-five patients were included in the study, 31 in group I and 34 in group II. Three patients initially randomized to group I were changed to group II as it was impossible to obtain a sample using the brush. The mean size of the CPL was 28.2 mm (range 16-60 mm). The diagnostic accuracy of EUS-EB was not superior to EUS-FNA, neither in the ITT nor the PP analysis (44.8% vs 41.1%, p = 0.77 and 38.4% vs 45.9%, p = 0.55).

Conclusions: EUS-EB does not improve the diagnostic accuracy of CPL in comparison with EUS-FNA.
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http://dx.doi.org/10.17235/reed.2018.5449/2017DOI Listing
August 2018

Practice guidelines for endoscopic ultrasound-guided celiac plexus neurolysis.

Endosc Ultrasound 2017 Nov-Dec;6(6):369-375

Division of Gastroenterology and Liver Diseases, Montefiore Medical Center, Bronx, New York, USA.

Objectives: The objective of guideline was to provide clear and relevant consensus statements to form a practical guideline for clinicians on the indications, optimal technique, safety and efficacy of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN).

Methods: Six important clinical questions were determined regarding EUS-CPN. Following a detailed literature review, 6 statements were proposed attempting to answer those questions. A group of expert endosonographers convened in Chicago, United States (May 2016), where the statements were presented and feedback provided. Subsequently a consensus group of 35 expert endosonographers voted based on their individual level of agreement. A strong recommendation required 80% voter agreement. The modified GRADE (Grading of Recommendations Assessment, Development, and Evaluation) criteria were used to rate the strength of recommendations and the quality of evidence.

Results: Eighty percent agreement was reached on 5 of 6 consensus statements, 79.4% agreement was reached on the remaining one.

Conclusions: EUS-CPN is efficacious, should be integrated into the management of pancreas cancer pain, and can be considered early at the time of diagnosis of inoperable disease. Techniques may still vary based on operator experience. Serious complications exist, but are rare.
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http://dx.doi.org/10.4103/eus.eus_97_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5752758PMC
December 2017

A multi-institutional consensus on how to perform endoscopic ultrasound-guided peri-pancreatic fluid collection drainage and endoscopic necrosectomy.

Endosc Ultrasound 2017 Sep-Oct;6(5):285-291

Endoscopy Center, Sheng Jing Hospital of Medical University, Shenyang, China.

There is a lack of consensus on how endoscopic ultrasound (EUS)-guided pseudocyst drainage and endoscopic necrosectomy should be performed. This survey was carried out amongst members of the EUS Journal Editorial Board to describe their practices in performing this procedure. This was a worldwide multi-institutional survey amongst members of the EUS Journal Editorial Board in May 2017. The responses to a 22-question survey with respect to the practice of EUS-guided pseudocyst drainage and endoscopic necrosectomy were obtained. Twenty-two endoscopists responded to the questionnaire as follows: 72.7% (16/22) were of the opinion that lumen-apposing metal stents (LAMS) should be the standard of care for the creation of an endoscopic cystenterostomy in patients with pancreatic walled-off necrosis (WON); 95.5% (21/22) recommended large diameter (d=15 mm) LAMS for drainage in patients with WON; 54.5% (12/22) would not dilate LAMS after placement into the WOPN; 86.4% (19/22) would not perform endoscopic necrosectomy during the same procedure as the creation of the cystenterostomy; 45.5% (10/22) recommend that agents, such as diluted hydrogen peroxide, should be used to lavage the peri-pancreatic fluid collection (PFC) cavity in patients with WON; and 45.5% (10/22) considered a naso-cystic or other tube to be necessary for lavage of WON after initial drainage. The mean optimal interval recommended for endoscopic necrosectomy procedures after EUS-guided drainage was 6.23 days. The mean optimal interval recommended for repeat imaging in patients undergoing endoscopic necrosectomy was 12.32 days. The mean time recommended for LAMS removal was 4.59 weeks. This is the first worldwide survey on the practice of EUS-guided pseudocyst drainage and endoscopic necrosectomy. There were wide variations in practice and randomized studies are urgently needed to establish the best approach for management of this condition. There is also a pressing need to establish a best practice consensus.
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http://dx.doi.org/10.4103/eus.eus_85_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5664848PMC
October 2017

Efficacy of peroral endoscopic myotomy compared with other invasive treatment options for the different esophageal motor disorders.

Rev Esp Enferm Dig 2017 08;109(8):578-586

Aparato Digestivo, Complejo Hospitalario de Navarra, España.

Introduction: Peroral endoscopic myotomy (POEM) has been performed since 2008 on more than 5,000 patients. It has proven to be highly effective in the treatment of achalasia and has shown promising outcomes for other esophageal motility spastic disorders.

Methods: A literature review of the efficacy of POEM compared to the previous invasive treatments for different esophageal motility disorders was performed. The application in the pediatric and elderly populations and its role as a rescue therapy after other procedures are also outlined.

Results: Short-term outcomes are similar to laparoscopic Heller myotomy (LHM) and pneumatic endoscopic dilation (PD) (clinical success > 90%) for achalasia subtypes I and II. Mid-term outcomes are comparable to LHM and overcome the results obtained after PD (> 90% vs ~50%). With regard to type III achalasia, POEM efficacy is 98% compared to 80.8% for LHM and the PD success remains at 40%. With regard to spastic esophageal disorders (SED), POEM has an effectiveness of 88% and 70% for distal esophageal spasm (DES) and jackhammer esophagus (JE) respectively. A response of 95% in patients with sigmoid esophagus has been reported. POEM has been performed in pediatric and elderly populations and has obtained a higher efficacy than PD in pediatric series (100% vs 33%) without greater adverse events. Previous treatments do not seem to hinder POEM results with excellent response rates, including 97% in post LHM and 100% in a re-POEM series. Final considerations: POEM has shown excellent short and mid-term results for all subtypes of achalasia but long-term results are not yet available. The promising results in SED may make POEM the first-line treatment for SED. A high-safety profile and efficacy have been shown in elderly and pediatric populations. Previous treatments do not seem to diminish the success rate of POEM. Core tip: POEM has emerged as an efficient treatment option for all subtypes of achalasia and other scenarios (including previous treatments and elderly and pediatric populations). Short and mid-term results are comparable to LHM and are better than PD data. The clinical response rate of DES and JE may make POEM the first-line treatment for SED.
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http://dx.doi.org/10.17235/reed.2017.4773/2016DOI Listing
August 2017

Stent placement prior to initiation of chemotherapy in patients with obstructive, nonoperative left sided tumors is associated with fewer stomas.

J Surg Oncol 2017 Jun 15;115(7):856-863. Epub 2017 Feb 15.

Department of General Surgery, Coloproctology Unit, Complejo Hospitalario de Navarra, Pamplona, Spain.

Background And Objetives: Due to the potential risks associated with stent placement, European Society Gastrointestinal Endoscopy does not recommend prophylactic insertion of stents in patients without symptoms. The aim was to compare complication rates, need of surgery, colostomy formation, and survival between stent placement prior to start of chemotherapy (SEMS group) and upfront ChT (ChT group) in patients with endoscopically non-transverable metastatic left-sided colorectal cancer.

Methods: Gender, age, CEA, tumor location, sites of metastatic disease, peritoneal involvement, liver involvement, and angiogenesis inhibitors administration, were recorded. Complication rates, need of surgery, stoma creation, and survival were compared between both groups by univariate and multivariate test. Complications of SEMS placement in both groups were compared.

Results: We studied 75 men and 40 women, with a mean age of 66.3 years. Overall complication and perforation rates were similar but patients in the ChT group had a significant higher need of surgery and subsequent stoma creation. Perforation after SEMS placement rates were higher in patients receiving ChT than in patients without ChT. Survival was related to peritoneal carcinomatosis and administration of biological agents.

Conclusions: SEMS placement prior to ChT administration dismissed the need of subsequent surgery and decreased the rates of permanent stoma formation.
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http://dx.doi.org/10.1002/jso.24588DOI Listing
June 2017

Chronic Pancreatitis-Like Changes Detected by Endoscopic Ultrasound in Type 1 Diabetics Are Not Associated With Gastrointestinal Symptoms or Nutritional Deficiencies.

Pancreas 2017 01;46(1):102-105

From the *Department of Gastroenterology and †Department of Endocrinology, Complejo Hospitalario de Navarra, Pamplona, Spain.

Objectives: Previous studies have shown changes in the pancreas of type 1 diabetic (T1-DM) patients, similar to those present in patients with chronic pancreatitis. Our aim was to analyze the prevalence of endoscopic ultrasound (EUS) criteria for chronic pancreatitis in T1-DM, to determine the association with factors related to the diabetes and to define its clinical significance.

Methods: Eighty-six T1-DM patients were prospectively included. All of them underwent EUS. Standard criteria were used. Patients were divided into 3 groups according to the number of EUS criteria they met: group A, 0 to 2 criteria; group B, 3 to 4; and group C, more than 4. Association between EUS findings and demographic or clinical factors was studied as well as the relationship between EUS abnormalities and the presence of gastrointestinal symptoms or nutritional deficiencies.

Results: Fifty-three patients (61.6%) showed at least 1 morphologic abnormality. Fifty-eight patients were included in group A, 21 in group B, and 7 in Group C. No significant differences were found when comparing the 3 groups.

Conclusions: Chronic pancreatitis-like changes are frequent in the pancreas of T1-DM patients. These changes are not associated with demographic or clinical data. Therefore, the clinical relevance seems to be scarce.
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http://dx.doi.org/10.1097/MPA.0000000000000671DOI Listing
January 2017

Role of Intraluminal Esophageal Impedance Baseline in the Diagnosis of Esophagitis in Children.

Eur J Pediatr Surg 2017 Feb 21;27(1):44-49. Epub 2016 Oct 21.

Department of Pediatric Surgery, Hospital Universitario y Politécnico La Fe, Valencia, Spain.

 Low values of esophageal impedance baseline (EIB) have been related to esophagitis. The aim of this study was to evaluate the diagnostic performance of EIB for erosive esophagitis (ErE) and histological esophagitis (HiE) in children studied for gastroesophageal reflux.  Children who underwent esophageal multichannel intraluminal impedance-pH monitoring (MII-pH) and upper-endoscopy with esophageal biopsies were studied retrospectively. EIB values were obtained by MII-pH. ErE was assessed by endoscopy following the Hetzel-Dent classification; HiE was defined by basal zone hyperplasia, papillary lengthening, or inflammatory infiltration. EIB was compared between groups. Receiver operating characteristic (ROC) curves were obtained to calculate the global diagnostic performance of EIB and to find cut-off values for sensitivity and specificity. Logistic regression was used for age adjustment.  Fifty-one patients were studied: 11 had ErE and 23 had HiE. EIB median values were 1,159 in ErE versus 2,583 in non-ErE (U = 80,  < 0.01). The adjusted ROC curve analysis for ErE was 0.85 (95% CI = 0.74-0.96); the EIB cut-off value = 2,379 determined sensitivity = 100% and specificity = 52.6% in children < 4 years old. and sensitivity = 100% and specificity = 63.2% in children > 4 years old. EIB median values were 1,666 in HiE versus 2,669 in non-HiE ( = 80,  < 0.01). The adjusted ROC curve analysis for HiE was 0.75 (95% CI = 0.59-0.90); the EIB cut-off value = 2,296 determined sensitivity = 71.2% and specificity = 83.1% in children < 4 years old, and sensitivity = 75.1% and specificity = 80.1% in children > 4 years old.  EIB provides statistically significant diagnostic performances for ErE and HiE. It could become a useful tool, especially to discriminate between ErE and non-ErE, avoiding other invasive tests.
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http://dx.doi.org/10.1055/s-0036-1593609DOI Listing
February 2017
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