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Item does not contain fulltext BACKGROUND: Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In a previous phase 2 induction study, etrolizumab significantly improved clinical remission versus placebo in patients with moderately to severely active ulcerative colitis. We aimed to compare the safety and efficacy of etrolizumab with infliximab in patients with moderately to severely active ulcerative colitis. METHODS: We conducted a randomised, double-blind, double-dummy, parallel-group, phase 3 study (GARDENIA) across 114 treatment centres worldwide. We included adults (age 18-80 years) with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] of 6-12 with an endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1) who were naive to tumour necrosis factor inhibitors. Patients were required to have had an established diagnosis of ulcerative colitis for at least 3 months, corroborated by both clinical and endoscopic evidence, and evidence of disease extending at least 20 cm from the anal verge. Participants were randomly assigned (1:1) to receive subcutaneous etrolizumab 105 mg once every 4 weeks or intravenous infliximab 5 mg/kg at 0, 2, and 6 weeks and every 8 weeks thereafter for 52 weeks. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants, and baseline disease activity. All participants and study site personnel were masked to treatment assignment. The primary endpoint was the proportion of patients who had both clinical response at week 10 (MCS ≥3-point decrease and ≥30% reduction from baseline, plus ≥1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1) and clinical remission at week 54 (MCS ≤2, with individual subscores ≤1); efficacy was analysed using a modified intention-to-treat population (all randomised patients who received at least one dose of study drug). GARDENIA was designed to show superiority of etrolizumab over infliximab for the primary endpoint. This trial is registered with ClinicalTrials.gov, NCT02136069, and is now closed to recruitment. FINDINGS: Between Dec 24, 2014, and June 23, 2020, 730 patients were screened for eligibility and 397 were enrolled and randomly assigned to etrolizumab (n=199) or infliximab (n=198). 95 (48%) patients in the etrolizumab group and 103 (52%) in the infliximab group completed the study through week 54. At week 54, 37 (18·6%) of 199 patients in the etrolizumab group and 39 (19·7%) of 198 in the infliximab group met the primary endpoint (adjusted treatment difference -0·9% [95% CI -8·7 to 6·8]; p=0·81). The number of patients reporting one or more adverse events was similar between treatment groups (154 [77%] of 199 in the etrolizumab group and 151 [76%] of 198 in the infliximab group); the most common adverse event in both groups was ulcerative colitis (55 [28%] patients in the etrolizumab group and 43 [22%] in the infliximab group). More patients in the etrolizumab group reported serious adverse events (including serious infections) than did those in the infliximab group (32 [16%] vs 20 [10%]); the most common serious adverse event was ulcerative colitis (12 [6%] and 11 [6%]). There was one death during follow-up, in the infliximab group due to a pulmonary embolism, which was not considered to be related to study treatment. INTERPRETATION: To our knowledge, this trial is the first phase 3 maintenance study in moderately to severely active ulcerative colitis to use infliximab as an active comparator. Although the study did not show statistical superiority for the primary endpoint, etrolizumab performed similarly to infliximab from a clinical viewpoint. FUNDING: F Hoffmann-La Roche.

We aimed to investigate the diagnostic performance of new 2-D shear-wave elastography (SWE) with propagation maps and attenuation imaging (ATI) for quantification of fibrosis and steatosis in non- alcoholic fatty liver disease (NAFLD). Consecutive patients with NAFLD and healthy volunteers underwent liver stiffness measurement and steatosis quantification by means of vibration- controlled transient elastography coupled with the controlled attenuation parameter as the reference and by 2-D shear-wave elastography (2-D-SWE) with propagation maps and ATI as the investigational methods. We included 232 participants (164 in the NAFLD group and 68 in the healthy control group): 51.7%/49.3% women/men ; mean age, 54.2 +/- 15.2 y ; mean body mass index, 29.4 +/- 6.5 kg/m(2). Significant correlations were found between 2-D- SWE and vibration-controlled transient elastography (r = 0.71, p < 0.0001) and between ATI and the controlled attenuation parameter (r = 0.72, p < 0.0001). NAFLD-specific 2-D-SWE liver stiffness measurement cutoffs were as follows-F >= 2: 7.9 kPa (area under the curve [AUC] = 0.91) ; F >= 3: 10 kPa (AUC = 0.92) ; and F = 4: 11.4 kPa (AUC = 0.95). For steatosis, the best cutoffs by ATI were as follows-S1 = 0.73 dB/cm/MHz (AUC = 0.86) ; S2 = 0.76 dB/cm/MHz (AUC = 0.86) ; and S3 = 0.80 dB/cm/MHz (AUC = 0.83). According to Baveno VI criteria, the optimal 2-D-SWE liver stiffness measurement for diagnosing liver cirrhosis is 15.5 kPa (AUC = 0.94), and for ruling out compensated advanced chronic liver disease it is 9.2 kPa (AUC = 0.92). To conclude, 2-D-SWE with propagation maps and ATI is reliable for quantification of liver fibrosis and steatosis in patients with NAFLD.

The goal of this study was to evaluate the performance of two new ultrasound-based techniques (ShearWave PLUS elastography [2-D-SWE PLUS], SSp PLUS Imaging [SSp PLUS]) implemented on the Aixplorer Mach 30 ultrasound system (Supersonic Imagine, Aix-en-Provence, France) for the non-invasive assessment of liver steatosis and fibrosis, using transient elastography (TE) with the controlled attenuation parameter (CAP) as reference. This monocentric cross-sectional study included 133 consecutive adult patients with chronic hepatopathies. Liver stiffness and steatosis were evaluated in the same session using the techniques mentioned above. An excellent correlation was observed between liver stiffness measurements obtained with 2-D-SWE PLUS and TE (r = 0.92, p0.0001). The best cutoff value of 2-D-SWE PLUS for predicting F≥2 was 6.8 kPa; for F≥3, 8.4 kPa; and for F4, 11 kPa. With respect to steatosis evaluation, a strong negative correlation between CAP and SSp PLUS values (r = -0.70, p0.0001) was obtained. The best SSp PLUS cutoff value for predicting steatosis was 1537 m/s.

Tudor Parvanescu,1 Andrei Vitel,1 Ioan Sporea,2 Ruxandra Mare,2 Bogdan Buz,1 Diana Aurora Bordejevic,1 Mirela Cleopatra Tomescu,1 Sergiu Florin Arnautu,3 Vlad Ioan Morariu,1 Ioana Mihaela Citu1 1Cardiology Department, Victor Babes University of Medicine and Pharmacy, Timisoara, Romania; 2Department of Gastroenterology and Hepatology, Victor Babes University of Medicine and Pharmacy, Timisoara, Romania; 3Department of Neurology, Victor Babes University of Medicine and Pharmacy, Timisoara, RomaniaCorrespondence: Diana Aurora BordejevicCardiology Department, Victor Babe” University of Medicine and Pharmacy, 2nd Eftimie Murgu Square, Timisoara, RomaniaTel +40 734600550Fax +40 256220636Email aurora.bordejevic@umft.roBogdan BuzCardiology Department, “Victor Babes” University of Medicine and Pharmacy, 2nd Eftimie Murgu Square, Timisoara, RomaniaTel +40 756346910Email buzbogdan93@gmail.comPurpose: The constitutive elements of the metabolic syndrome (MetS) are linked with both non-alcoholic fatty liver disease (NAFLD) and cardiovascular disease. Controlled attenuation parameter (CAP), and vibration controlled transient elastography (VCTE), are able to detect and quantify NAFLD, while conventional and two-dimensional speckle tracking echocardiography (2D-STE) is capable to identify subclinical changes in cardiac function. We wanted to evaluate whether there is any correspondence between left ventricular (LV) diastolic dysfunction and different degrees of liver steatosis and fibrosis in MetS subjects with NAFLD.Patients and Methods: A total of 150 adult subjects having MetS and a normal left ventricular (LV) systolic function were recorded in the study, while 150 age- and sex- matched adults without MetS were enrolled as controls. NAFLD was established by VCTE and CAP. The left heart systolic and diastolic function was evaluated by conventional and 2D-ST echocardiography. Left atrial (LA) stiffness was calculated as the ratio between the E/A ratio and the LA reservoir-strain.Results: In univariate regression analysis, the variables associated with LV diastolic dysfunction in MetS patients were: liver steatosis grade ≥ 2, liver fibrosis grade ≥ 2, the longitudinal LA peak strain during the reservoir phase, the LA strain rate during ventricular contraction and the LA stiffness. In multivariate logistic regression, two variables were selected as independent predictors of LV diastolic dysfunction, namely the liver stiffness (P=0.0003) and the LA stiffness (P< 0.0001). LA stiffness predicted subclinical LV diastolic dysfunction in MetS patients with a sensitivity of 45% and a specificity of 96% when using a cut-off value > 0.38, and was significantly correlated with liver steatosis stage ≥ 2 and liver fibrosis stage ≥ 2.Conclusion: The present study confirms the association between liver stiffness, LA stiffness and LV diastolic dysfunction in MetS patients. Our study suggests that liver elastography and 2D-STE should become habitual assessments in MetS patients.Keywords: metabolic syndrome, strain and strain‑rate imaging, left atrial stiffness, left ventricular diastolic dysfunction, liver elastography, liver steatosis and fibrosis

The study aimed to establish the benefits of using spleen stiffness values measured by two elastography techniques as noninvasive markers for predicting varices needing treatment and comparing their performances. A prospective study was performed, including 107 subjects with compensated liver cirrhosis, who underwent upper digestive endoscopy, as well as spleen stiffness measurements by means of two elastography techniques: pSWE (point shear wave elastography using Virtual Touch Quantification-Siemens Acuson S2000) and 2D-SWE (2D-shear wave elastography-LOGIQ E9, General Electric). Reliable spleen stiffness measurements were obtained in 96.2% (103/107) patients by means of 2D-SWE and in 94.4% (101/107) subjects with pSWE; therefore, 98 subjects were included in the final analysis, of which 40.8% (40/98) had varices needing treatment. The optimal spleen stiffness cut-off value by 2D-SWE for predicting varices needing treatment was 13.2 kPa (AUROC 0.84), while for pSWE, it was 2.91 m/s (AUROC 0.90). Based on AUROC comparison, no difference between the performance of the two techniques for predicting varices needing treatment was found ( p = 0.1606 ). In conclusion, spleen stiffness measured by either 2D-SWE or pSWE is a reliable surrogate marker, with good feasibility, applicability, and predictive accuracy for varices needing treatment, with no significant difference between techniques.

Andrei Vitel,1,* Ioan Sporea,2 Ruxandra Mare,2 Christian Banciu,2 Diana-Aurora Bordejevic,1,* Tudor Parvanescu,1 Ioana Mihaela Citu,1 Mirela Cleopatra Tomescu1 1Cardiology Department, “Victor Babes” University of Medicine and Pharmacy, Timisoara, Romania; 2Gastroenterology Department, “Victor Babes” University of Medicine and Pharmacy, Timisoara, Romania*These authors contributed equally to this workCorrespondence: Ioana Mihaela CituCardiology Department, “Victor Babes” University of Medicine and Pharmacy, 2 nd Eftimie Murgu Square, Timisoara, RomaniaTel +40 724353666Fax +40 256220636Email ioanamihaela2010@gmail.comPurpose: The components of metabolic syndrome (MS) are risk factors for developing both cardiovascular disease (CVD) and non-alcoholic fatty liver disease (NAFLD). Strain (SI) and strain‑rate imaging (SRI) are able to recognize early changes in cardiac function. Vibration-controlled transient elastography (VCTE) and controlled attenuation parameter (CAP) detect and quantify liver fibrosis and steatosis. We aimed to assess whether there is any correlation between liver fibrosis and steatosis and left ventricular (LV) dysfunction in MS patients.Patients and Methods: A total of 150 adults with MS were registered in the study. They were compared with a control group of 150 age- and sex-matched adults without MS. After the classic echocardiographic assessment of LV function, two-dimensional speckle echocardiography (2D-STE) was used to evaluate LV peak systolic strain (S) and peak systolic strain rate (SR), while liver steatosis and fibrosis were evaluated by VCTE and CAP.Results: LV diastolic dysfunction was significantly more frequent among the patients with MS. We found significant differences between the two groups regarding the presence of subtle LV systolic dysfunction, detected by reduced values of S and SR. The risk for LV diastolic dysfunction was 3.6 times higher in MS with severe steatosis and 8 times higher in patients with severe fibrosis, P< 0.0001. The risk for LV systolic dysfunction was double in MS with severe steatosis and 1.7 times higher in MS with severe fibrosis, P< 0.0001.Conclusion: In MS patients with normal LV ejection fraction, conventional echocardiography parameters identified diastolic LV dysfunction, while SI and SRI identified subtle impairment of systolic LV dysfunction. The presence of hepatic steatosis and fibrosis increases significantly the risk for cardiac dysfunction in MS patients (P< 0.0001).Keywords: metabolic syndrome, left ventricular function, strain and strain‑rate imaging, liver steatosis and fibrosis, liver elastography

Aim Current major guidelines recommend risk stratification of the thyroid nodules, after each diagnostic evaluation, in order to focus attention on potentially risky nodules. The main aim of our study was to evaluate the performance of combined advanced ultrasound techniques in this process, compared with conventional stratification models, in order to reduce unnecessary fine-needle biopsies, respectively, surgery. Material and methods We evaluated 261 cases (261 nodules) using conventional ultrasound (2B), real-time Doppler evaluation (4D) respectively, real-time elastography, using a linear multifrequency probe and a linear volumetric probe (Hitachi Prerius Machine, Hitachi Inc, Japan). All the nodules were classified using a risk stratification model comprising seven conventional US characteristics, two 4 D characteristics and a color map RTE aspect. The results were compared with the pathology results, considered the golden standard diagnosis. Results The prevalence of malignant nodules was 21.83% (57 cases). Conventional risk classification generated: 106 low-risk cases, 113 intermediate-risk and 42 high-risk cases. Our proposed risk classification changes the conventional risk classification with a risk upgrade in 27 cases and with a risk downgrade in 69 cases. The diagnostic quality of the combined risk stratification model was better, considering a low-risk category predictive for benignancy and a high category predictive for malignancy: Sensitivity: 80.88% versus 49.01%, respectively, Specificity: 91.22% versus 54.38. The diagnostic power differences were observed regardless of the nodule size. Conclusion Advanced ultrasound techniques did add diagnostic value in the presurgical risk assessment of the thyroid nodules.

Background: Sarcopenia is now recognized more and more as a biomarker with poor outcomes in cirrhotic patients.Aims: The purpose of this study was to investigate the prevalence of sarcopenia in patients with liver cirrhosis and prospectively investigate the association between sarcopenia and different complications and its impact on survival.Material and Methods: This prospective study included patients with liver cirrhosis admitted to our department from 2018 to 2020. Sarcopenia was assessed according to EWGSOP2 criteria, incorporating low Handgrip strength (Results: A total of 201 patients were enrolled in the study, 63.2% male, mean age 61.65 ± 9.49 years, 79.6% Child-Pugh class B and C. The primary etiology of liver cirrhosis was alcohol consumption (55.2%). The prevalence of sarcopenia was 57.2 %, with no significant differences between the male and female groups. Significant associations were found between sarcopenia and portal hypertension-related complications, infectious complications, and risk of hepatocellular carcinoma. In multivariate analysis, sarcopenia was assessed as a risk factor alone, increasing the risk for ascites 3.78 times, hepatocellular carcinoma by 9.23 times, urinary tract infection by 4.83 times, and spontaneous peritonitis 2.49 times. Sarcopenia was associated with more extended hospital stay and higher 30 days readmission. Six months and 1-year survival were reduced in the sarcopenia group than in the non-sarcopenia group (p < 0.0001).Conclusion: Sarcopenia is a common complication of liver cirrhosis and associates with adverse health-related outcomes and poor survival rates.

This study aimed to analyze the utility of bidimensional shear-wave elastography for renal assessment and in the prediction of chronic kidney disease (CKD).The study included 92 subjects: 50 healthy volunteers and 42 patients with different degrees of CKD (mean age, 57.5 ± 13.4; 50% were female), excluding those undergoing renal replacement therapies, obstructive pathology, or renal lithiasis. We performed kidney shear-wave velocity (KSWV) determinations in the midportion of the parenchyma of each kidney. The median values were expressed in meters per second.We obtained successful assessments in 94% of the cases for the right kidney (RK) and 90.2% for the left kidney (LK), with an intraclass correlation coefficient of 0.96 (RK) and 0.91 (LK). We obtained significantly lower KSWV values in the CKD lot as opposed to the healthy volunteers: RK: 1.38 ± 0.1 versus 1.78 ± 0.1 m/s, P = 0.05; LK: 1.37 ± 0.1 m/s versus 1.72 ± 0.1 m/s. We could predict the presence of CKD with a sensitivity of 89.2% and a specificity of 76.9% for a KSWV of less than 1.47 m/s, with a tendency of KSWV to decrease with CKD progression.Our study shows that KSWV measured using bidimensional shear-wave elastography decreases in patients with CKD compared with normal subjects, and that for a cutoff value of below 1.47 m/s we could predict, with a good sensitivity and specificity, the presence of CKD.

Aim: This study evaluated the accuracy of contrast-enhanced ultrasound (CEUS) for the differential diagnosis of benign vs. malignant focal liver lesions (FLL) in a real-life, multicenter experience. Methods: This prospective study, including 14 Romanian centers, was performed over a 6 year period (February 2011- April 2017) and included 2062 FLLs assessed by CEUS. Inclusion criteria were: newly diagnosed FLL on B-mode ultrasound, less than three lesions/patient, all FLLs evaluated by CEUS and by a second-line imaging technique (contrast enhanced CT or contrast enhanced MRI) or histology, considered as reference. The trial was registered in clinicaltrials.gov (Identifier NCT01329458). Results: From the 2062 FLLs included in the study, 57.2% (1179) were malignant and 42.8% (883) were benign. CEUS had 83.9% sensitivity (Se), 97.8% specificity (Sp), 98.1% positive predictive value (PPV), 82.2% negative predictive value (NPV) and a diagnostic accuracy (Ac) of 89.9% for the positive diagnosis of malignant lesions. For the benign lesions, CEUS had 97.8% Se, 83.9% Sp, 82.2% PPV, 98.1% NPV 89.9% Ac. The diagnostic performance of CEUS for hepatocellular carcinoma was 76.6% Se, 98.4% Sp, and 91.2% Ac; for hemangioma: 89.2% Se, 99% Sp, and 96.9% Ac and for metastases: 90.9% Se, 98.4% Sp, and 96.9% Ac. Conclusions: CEUS proved a high accuracy in differentiating the malignant vs. benign character of a FLL. It can be confidently used as a first line imaging method in daily practice.

An interdisciplinary task force of European experts summarizes the value of gastrointestinal ultrasound (GIUS) in the management of acute appendicitis and diverticulitis. Based on an extensive literature review, clinical recommendations for these highly common diseases in visceral medicine are presented.In patients with acute appendicitis, preoperative sonography has been established as a routine procedure in most European countries for medical and legal reasons. Routine sonography in these patients may reduce the rate of unnecessary surgery by half. The sensitivity, specificity, and accuracy of ultrasound reach values above 90 % and are equivalent to CT and MRI. However, the high operator dependence may be a problem, for example in point-of-care ultrasound in emergency departments. Structured training programs, quality controls and standardized ultrasound reporting should be increasingly implemented.In the case of suspected acute diverticulitis, "ultrasound first" should also be a basic element in the approach to all patients. Sonography can confirm the diagnosis and allows early risk stratification. As treatment strategies have become less aggressive and more tailored to the stage of diverticulitis, accurate staging has become increasingly important. GIUS and CT have proven to have similar sensitivity and specificity. Especially in cases of uncomplicated diverticulitis, GIUS will be the one and only imaging procedure. CT may work as a backup and has particular advantages for diverticulitis located in the distal sigmoid, inflammation deep in the small pelvis and insufficient ultrasound scanning conditions. This step-up approach (ultrasound first and CT only in case of a negative or inconclusive ultrasound result) has proven to yield the best accuracy.Im Rahmen des EFSUMB-Leitlinienprojekts zum gastrointestinalen Ultraschall (GIUS) gibt eine interdisziplinäre Arbeitsgruppe von europäischen Experten einen Überblick zum Nutzen der Sonografie bei akuter Appendizitis und Divertikulitis. Basierend auf einer umfangreichen Literaturrecherche werden klinische Empfehlungen zu diesen häufigen Erkrankungen der Viszeral-Medizin vorgestellt.Bei Patienten mit akuter Appendizitis haben medizinische und juristische Erwägungen die präoperative Sonografie heute als Routineverfahren in den meisten europäischen Ländern fest etabliert. Die Sonografie kann hier die Rate unnötiger Operation halbieren. Sensitivität, Spezifität und Genauigkeit des Ultraschalls erreichen Werte von über 90 % und entsprechen CT oder MRT. Eine hohe Untersucherabhängigkeit kann jedoch problematisch sein, beispielsweise beim bettseitigen Ultraschall in der Notaufnahme oder Praxis. Strukturierte Trainingsprogramme, Qualitätskontrollen und ein standardisierter Befundbericht sollten deshalb Einzug in den klinischen Alltag finden. Auch beim Verdacht auf eine akute Divertikulitis sollte die „ultrasound first“-Strategie Anwendung finden.Die Sonografie kann die Diagnose einer Divertikulitis bestätigen und den Schweregrad abschätzen. Da heutige Therapiestrategien weniger aggressiv und mehr auf das Stadium der Divertikulitis zugeschnitten sind, ist eine genaue Einteilung des Schweregrads immer wichtiger geworden. GIUS und CT haben hier eine ähnliche Sensitivität und Spezifität. Gerade bei unkomplizierter Divertikulitis ist die Sonografie völlig ausreichend. Das CT kann als Backup dienen und hat Vorteile bei der Divertikulitis im distalen Sigma, bei einer Entzündung tief im kleinen Becken oder bei unzureichenden Untersuchungsbedingungen. Eine solche Stufendiagnostik (Ultraschall zuerst und CT nur im Falle eines negativen oder nicht eindeutigen Befundes) hat bei der Divertikulitis die höchste Genauigkeit bewiesen.

(1) Background: Patients suffering from the novel coronavirus 2019 (COVID-19) disease could experience several extra-pulmonary involvements, including cardiovascular complications and liver injury. This study aims to evaluate the presence of cardiac and liver alterations in patients with post-acute COVID-19 syndrome using transthoracic echocardiography (TTE) and liver elastography (LE). (2) Methods: A total of 97 subjects recovering from COVID-19, attending the hospital’s specialized outpatient clinic for persisting symptoms at 3 to 11 weeks after the acute illness, were included in this study. They all had a basal COVID-19 assessment, and subsequently, a clinical evaluation, laboratory tests, TTE, and LE. (3) Results: considering the presence of pulmonary injury during COVID-19, patients were divided into two groups. Although none of them had altered systolic function, we evidenced pulmonary hypertension, diastolic dysfunction, increased liver stiffness, viscosity, and steatosis in around one-third of the patients, with significantly higher values in subjects with pulmonary injury compared to those without. (4) Conclusion: persisting symptoms characterizing the post-acute COVID-19 syndrome could be explained by residual cardiac and hepatic lesions, which were worse in more severe COVID-19 forms. These patients may be at risk of developing liver fibrosis and cardiac alterations and should be investigated in the first 12 weeks after the onset of the infection.

Aim : Contrast-enhanced ultrasound (CEUS) has become a relevant imaging method for the evaluation of focal liver le- sions (FLL). The aim of this study was to evaluate the performance of CEUS for the assessment of focal nodular hyperplasia (FNH) in a large study group. Material and methods : We performed a multicentre prospective observational study, which included successive CEUS examinations from fourteen Romanian centres. CEUS examinations were performed in de novo FLL, using low mechanical index ultrasound, following an intravenous bolus of 2.4 ml SonoVue. CEUS was considered conclusive for FNH if a typical pattern was present following contrast (rapid “spoke-wheel” enhancement during the arterial phase, hyperenhanced lesion during venous phase, hyper- or isoenhanced in the late phase). In all cases a reference method was available (contrast enhanced CT or MRI or biopsy). The trial was registered in clinicaltrials.gov (Identifier NCT01329458). Results : During the 6 years study, 2062 “de novo” FLL were evaluated by CEUS. From this cohort, 94/2062 (4.5%) had a typical enhancing pattern for FNH as described in the EFSUMB guidelines. Contrast enhanced CT/MRI and biopsy diagnosed additional 15 FNH. From the 94 cases diagnosed as FNH by CEUS, in nine the final diagnosis was different (five of them adenomas). CEUS had 85% sensitivity, 99.5% specificity, 90.4% positive predictive value, 99.2% negative predictive value and 98.8% diagnostic accuracy for the diagnosis of FNH. Conclusions : CEUS is a sensitive and very specific method for the diagnosis of FNH.

Background and Aims: The nonpharmacological therapy in irritable bowel syndrome (IBS) is expanding rapidly. Practitioners and medical educators need to be aware of progress and changes in knowledge of this topic. The Romanian Society of Neurogastroenterology aimed to create guidelines based on best evidence on the use of nonpharmacological therapy in IBS. Methods: A group of experts was constituted. This was divided in eleven subgroups dedicated to eleven categories of nonpharmacological therapy. The subgroups searched the literature and formulated statements and recommendations. These were submitted to vote in order to obtain consensus. Results: The outcome of this activity is represented by the guidelines of the Romanian Society of Neurogastroenterology, presented in this paper. The recommendations are seen as complementary to the pharmacological therapy and are not intended to recommend avoiding pharmacological drugs. Conclusions: These guidelines were elaborated by a Delphi process and represent a useful tool for physicians managing patients with IBS.

Lille score at Day 7 (LM7) helps to predict the outcome of patients with severe alcoholic hepatitis (sAH) undergoing corticotherapy. Several scores such as Maddrey’s discriminant function (MDF), MELD, ABIC, and GAHS are used for a 28-day mortality prognosis. Our study aimed to evaluate if the assessment of the Lille score at 4 days (LM4) is as useful as the Lille score at Day 7 (LM7) to predict response to corticosteroids and 28-day mortality and evaluate the utility of severity scores at admission for predicting the prognosis of patients with liver cirrhosis (LC) and severe alcoholic hepatitis (sAH). A retrospective study was performed, and all consecutive patients with AH and MDF &gt, 32 without contraindications to corticosteroids were included. Prognostic scores were evaluated at admission, and 28-day mortality was assessed. Response to corticotherapy was assessed by LM4 and LM7. Results: A total of 55/103 patients with sAH (51.5%) had MDF &gt, 32 and received corticosteroids. There was no difference between the proportion of patients with a responder LM4 versus LM7 (27% vs. 36%, p = 0.31). The mean value for LM4 was 0.64 ± 0.3 versus 0.60 ± 0.3 for LM7 (p = 0.48). Precisely 90.3% of patients were correctly identified as responders or not by LM4 compared with LM7. The best model for predicting 28-day mortality was composed of MELD and LM4/LM7, with an accuracy of 0.90 for both combinations. Conclusion: LM4 could be used instead of LM7 for predicting response to corticosteroid therapy in patients with sAH and LC, as well as 28-day mortality. Using LM4, we could avoid prolonged use of this therapy and its complications.

The present study evaluates the performance of Baveno VI criteria, using liver stiffness (LS) assessed with a 2D-SWE elastography technique, for predicting high-risk varices (HRV) in patients with compensated advanced chronic liver disease (cACLD). A secondary aim was to determine whether the use of spleen stiffness measurements (SSMs), as additional criteria, increases the performance of the 2D-SWE Baveno VI criteria. Data were collected from 208 subjects with cACLD, who underwent abdominal ultrasound, liver and spleen stiffness measurements, and upper digestive endoscopy. HRV were defined as grade 1 esophageal varices (EV) with red wale marks, grade 2/3 EV, and gastric varices. A total of 35.6% (74/208) of the included subjects had HRV. The optimal LS cut-off value for predicting HRV was 12 kPa (AUROC-0.80). Using both LS cut-off value < 12 kPa and a platelet cut-off value > 150 × 109 cells/L as criteria to exclude HRV, 52/208 (25%) subjects were selected, 88.5% (46/52) were without EV, 9.6% (5/52) had grade 1 EV, and 1.9% (1/52) had HRV. Thus 98% of the subjects were correctly classified as having or not having HRV and 25% of the surveillance endoscopies could have been avoided. Using SS < 13.2 kPa and a platelet cut-off value > 150 × 109 cells/L as additional criteria for the patients that were outside the initial ones, 32.7% of the surveillance endoscopies could have been avoided.

Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. This study aimed to evaluate the performance of four ultrasound-based techniques for the non-invasive multiparametric (MPUS) assessment of liver fibrosis (LF), steatosis (HS), and inflammation in patients with NAFLD. We included 215 consecutive adult patients with NAFLD (mean age: 54.9 ± 11.7; 54.5% were male), in whom LF, HS, and viscosity were evaluated in the same session using four new ultrasound-based techniques embedded on the Aixplorer MACH 30 system: ShearWave Elastography (2D-SWE.PLUS), Sound Speed Plane-wave UltraSound (SSp.PLUS), Attenuation Plane-wave UltraSound (Att.PLUS), and Viscosity Plane-wave UltraSound (Vi.PLUS). Transient Elastography (TE) with Controlled Attenuation Parameter (CAP) (FibroScan) were considered as control. All elastographic measurements were performed according to guidelines. Valid liver stiffness measurements (LSM) were obtained in 98.6% of patients by TE, in 95.8% of patients by 2D-SWE.PLUS/Vi.PLUS, and in 98.1% of patients by Att.PLUS/SSp.PLUS, respectively. Therefore, 204 subjects were included in the final analysis. A strong correlation between LSMs by 2D-SWE.PLUS and TE (r = 0.89) was found. The best 2D-SWE.PLUS cut-off value for the presence of significant fibrosis (F ≥ 2) was 7 kPa. Regarding steatosis, SSp.PLUS correlated better than Att.PLUS with CAP values: (r = −0.74) vs. (r = 0.45). The best SSp.PLUS cut-off value for predicting the presence of significant steatosis was 1524 m/s. The multivariate regression analysis showed that Vi.PLUS values were associated with BMI and LSM by 2D-SWE.PLUS. In conclusion, MPUS was useful for assessing fibrosis, steatosis, and inflammation in a single examination in patients with NAFLD.

Aims: We aimed to compare the diagnostic performance of two 2D-Shear Wave Elastography (2D-SWE) techniques for the non-invasive assessment of liver fibrosis in patients with chronic hepatitis C virus (HCV) infection using Transient Elas- tography (TE) as reference. Material and methods: We enrolled 208 consecutive patients with chronic HCV infection, in which liver stiffness (LS) was evaluated in the same session using two 2D-SWE techniques: 2D-SWE.GE and 2D-SWE.SSI using TE as the method of reference. LS measurements were considered failures when no value was obtained after 10 attempts. Results: Valid LSMs were obtained in 95.6% (199/208) of cases by 2D-SWE.GE, 92.7% (193/208) of cases by 2D-SWE.SSI, and in 94.7% (197/208) of cases by TE (p>0.05). The mean LS values by 2D-SWE.GE were significantly lower than those obtained by 2D-SWE.SSI: 10.3±3.8 kPa vs. 15±10.4 kPa (p

Aim: The updated Baveno VI guidelines recommend that screening for high-risk varices (HRV) by esophago-gastro-duodenoscopy (EGD) can be avoided in patients with compensated advanced chronic liver disease (cACLD) who have liver stiffness LSM150,000/L. The aims of this study were to validate extended Baveno VI criteria in patients with chronic liver disease and to establish cut-off values for our cohort. Materials and Methods: This retrospective study included 839 patients with liver cirrhosis evaluated by Transient Elastography (TE), biological tests, and upper endos-copy, all within one year. The Baveno VI criteria were validated on a sub-group of 728 patients (Cohort 1, randomly selected from the study sample) and tailored cut-off points were determined. The remaining 111 patients comprised the validating set (Cohort 2) for these specific cut-off values. Results: In Cohort 1, Baveno VI criteria had 86.2% accuracy. The calculated cut-offs to rule-in HRV were PLT35.3 kPa; while to rule-out HRV they were PLT >150.000/mm3 and LSM

Objectives: In this study, we aim to determine the elastographic characteristics of both primary and secondary hyperparathyroidism using shear wave elastography. We also aim to evaluate the elastographic differences between them, as well as the differences between the parathyroid, thyroid, and muscle tissue, in order to better identify a cutoff value for the parathyroid tissue. Methods: In this prospective study, we examined a total of 68 patients with hyperparathyroidism, divided into two groups, one group consisted of 27 patients with primary hyperparathyroidism and the other group consisted of 41 selected patients with confirmed secondary hyperparathyroidism. The elasticity index (EI) was determined in the parathyroid, thyroid, and muscle tissue. The determined values were compared to better identify the parathyroid tissue. Results: The median value of mean SWE values measured for parathyroid adenomas from primary hyperparathyroidism was 4.86 kPa. For secondary hyperparathyroidism, the median value of mean SWE was 6.96 KPa. The median (range) presurgical values for parathormone (PTH) and calcium were 762.80 pg/mL (190, 1243) and 9.40 mg/dL (8.825, 10.20), respectively. We identified significant elastographic differences between the two groups (p &lt, 0.001), which remained significant after adjusting elastographic measures to the nonparametric parameters, such as the parathormone value and vitamin D (p &lt, 0.001). The cutoff values found for parathyroid adenoma were 5.96 kPa and for parathyroid tissue 9.58 kPa. Conclusions: Shear wave elastography is a helpful tool for identifying the parathyroid tissue, in both cases of primary and secondary hyperparathyroidism, as there are significant differences between the parathyroid, thyroid, and muscle tissue. We found a global cutoff value for the parathyroid tissue of 9.58 kPa, but we must keep in mind that there are significant elastographic differences between cutoffs for primary and secondary hyperparathyroidism.

ObjectiveLiver stiffness measurement (LSM) is a tool used to screen for significant fibrosis and portal hypertension. The aim of this retrospective multicentre study was to develop an easy tool using LSM for clinical outcomes in advanced chronic liver disease (ACLD) patients.DesignThis international multicentre cohort study included a derivation ACLD patient cohort with valid two-dimensional shear wave elastography (2D-SWE) results. Clinical and laboratory parameters at baseline and during follow-up were recorded. LSM by transient elastography (TE) was also recorded if available. The primary outcome was overall mortality. The secondary outcome was the development of first/further decompensation.ResultsAfter screening 2148 patients (16 centres), 1827 patients (55 years, 62.4% men) were included in the 2D-SWE cohort, with median liver SWE (L-SWE) 11.8 kPa and a model for end stage liver disease (MELD) score of 8. Combination of MELD score and L-SWE predict independently of mortality (AUC 0.8). L-SWE cut-off at ≥20 kPa combined with MELD ≥10 could stratify the risk of mortality and first/further decompensation in ACLD patients. The 2-year mortality and decompensation rates were 36.9% and 61.8%, respectively, in the 305 (18.3%) high-risk patients (with L-SWE ≥20 kPa and MELD ≥10), while in the 944 (56.6%) low-risk patients, these were 1.1% and 3.5%, respectively. Importantly, this M10LS20 algorithm was validated by TE-based LSM and in an additional cohort of 119 patients with valid point shear SWE-LSM.ConclusionThe M10LS20 algorithm allows risk stratification of patients with ACLD. Patients with L-SWE ≥20 kPa and MELD ≥10 should be followed closely and receive intensified care, while patients with low risk may be managed at longer intervals.

Background and Aims: The 12-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir (OPrD) has shown high efficacy and tolerability in clinical trials for the treatment of chronic hepatitis C virus (HCV). The shorter 8-week regimen has been recently incorporated into clinical guidelines and on-label indications, but real-world evidence on its use is limited. Given this knowledge gap, the AMETHYST study aimed to evaluate the effectiveness of the 8- and 12-week regimens of OPrD in treatment-naive patients with HCV with mild to moderate liver fibrosis in Romanian clinical practice. Methods: This was a secondary data collection study analyzing data from a 1-year Patient Support Program in HCV in Romania. Patients received OPrD treatment for 8 or 12 weeks. The effectiveness endpoint was sustained virologic response 12 weeks post-treatment (SVR12). Results: A total of 1,835 treatment-naive patients with HCV with mild or moderate fibrosis were included in the study. Of these, 426 and 1,375 completed the 8-week and 12-week regimens, respectively. SVR12 was 98.1% in the 8-week treatment group and 98.7% in the 12-week treatment group. Conclusion: The study provides real-world evidence that 8-week and 12-week treatment regimens of OPrD are highly effective in treatment-naive patients with HCV with mild to moderate liver fibrosis.

Chronic liver diseases (CLDs) are a public health problem, even if frequently they are underdiagnosed. Hepatic steatosis (HS), encountered not only in nonalcoholic fatty liver disease (NAFLD) but also in chronic viral hepatitis, alcoholic liver disease, etc., plays an important role in fibrosis progression, regardless of CLD etiology; thus, detection and quantification of HS are imperative. Controlled attenuation parameter (CAP) feature, implemented in the FibroScan® device, measures the attenuation of the US beam as it passes through the liver. It is a noninvasive technique, feasible and well accepted by patients, with lower costs than other diagnostic techniques, with acceptable accuracy for HS quantification. Multiple studies have been published regarding CAP performance to quantify steatosis, but due to the heterogeneity of CLD etiologies, of steatosis prevalence, etc., it had widely variable calculated cut-off values, which in turn limited the day-to-day utility of CAP measurements in clinical practice. This paper reviews published studies trying to suggest cut-off values usable in clinical practice.

The study evaluates the utility of spleen (SS) and liver stiffness (LS) associated with spleen size (SSZ) as non-invasive markers for predicting high-risk varices (HRV). One hundred thirty-two patients with compensated liver cirrhosis who underwent abdominal ultrasound SS (SSM) and LS measurements (LSM) using a 2-D shear wave elastography (2-D-SWE) technique from General Electric and upper endoscopy were included. Similar rates of reliable SSM and LSM were obtained (95.4% and 97.7% respectively); therefore, 124 patients were included in the final analysis. The optimal cutoff values for SS, LS and SSZ for predicting HRV were 13.2 kPa (area under the receiver operating characteristic curve [AUROC] = 0.84), 12.1 kPa (AUROC = 0.86) and 12.9 cm (AUROC = 0.71), respectively. Including these factors in multiple regression analysis, we obtained the scores for predicting HRV: 0.053 × SS + 0.054 × LS + 0.059 × SSZ – 1.84. The score's optimal cutoff value for predicting HRV was >0.34 (AUROC = 0.93). By comparing the AUROC's, the score including SSZ, SSM and LSM performed better than each independent factor for predicting HRV (p = 0.0091; p = 0.0341; p

Fine needle aspiration (FNA) is recommended as the final evaluation in diagnosing thyroid nodules. Intermediate cytology is observed in about 15%&ndash, 25% of the FNA results and has divergent recommendations: follow-up or surgery, either hemi- or total thyroidectomy. The present study aimed to assess the benefit of multimodal ultrasound (US) evaluation in clarifying the attitude in cases with intermediate cytology on FNA. Sixty-four successive cases with Bethesda III or IV cytology results were evaluated using two-dimensional B-mode US (2B), qualitative strain elastography, as well as planar and volumetric (3D) color Doppler using both a linear multifrequency probe and a linear volumetric probe (Hitachi Preirus Machine, Hitachi Inc. Japan). The analyzed nodules were all categorized as low, intermediate, or high risk, based on the following US criteria: taller-than-wide shape, marked hypoechogenicity, irregular borders, inhomogeneity, microcalcifications, or the presence of suspicious adenopathy. Elastographic criteria included stiff lesions, while volumetric Doppler criteria included moderate and marked perinodular vascularization, as suspicious for malignancy. The gold standard for the analysis was the result of the pathology report after thyroidectomy. Our results showed that the prevalence of cancer was 25% (16 cases). In five cases, borderline follicular neoplasia was identified, group which requires watchful waiting. These lesions were also considered as malignant in the final analysis, with a total number of 21 neoplasm cases. Sixteen of the 21 malignant nodules presented with high stiffness, while 15/21 had increased perinodular vascularization. Eight of the 21 cases displayed both important stiffness and perinodular vascularization. Cancer prevalence increased both with severity of stiffness (9.0%&ndash, 15.0%&ndash, 66.6%&ndash, 80.0%) and intensity of vascularization in the adjacent perinodular parenchyma (18.2%&ndash, 27.7%&ndash, 35.29%&ndash, 50.0%). Combining the use of grayscale US, elastography, and 3D Doppler in the evaluation of intermediate cytology cases showed a sensitivity of 85.7%, a specificity of 88.3%, and an accuracy of 90.3% in detecting thyroid cancer cases. We can conclude that the identification of highly suspicious US characteristics observed in 2B, qualitative elastography, and volumetric Doppler increases the risk of malignancy.

Aim: The study compared the usefulness of 2D-SWE and attenuation measurements obtained using Aplio i800 from Canon together with Transient Elastography (TE) and the Controlled Attenuation Parameter (CAP) as the reference method.Material and methods: We included 112 consecutive adults with reliable LS measurements, 44 healthy subjects and 68 subjects with chronic hepatopathies in whom liver stiffness (LS) and steatosis were evaluated in the same session employing two elastography techniques: Transient Elastography (TE) with Controlled Attenuation Parameter (CAP) implemented on the FibroScan® 530 Compact system and Two Dimensional Shear Wave Elastography (2D-SWE) with Attenuation Imaging (ATI) installed on the Aplio i800 series ultrasound system. Reliable measurements were defined as the median value of 10, respectively 5 valid LS measurements for TE and 2D-SWE, with an interquartile range interval/median ratio (IQR/M)

Aims: Our aim was to assess the diagnostic performance of transient elastography (TE) and Virtual Touch Quantification (VTQ), a point Shear Wave Elastography (pSWE) technique, using Acoustic Radiation Force Impulse (ARFI) technology, for liver fibrosis assessment, as compared to percutaneous liver biopsy (LB), in patients with chronic hepatitis B or C. Methods: We analyzed 157 patients (80 with chronic hepatitis B and 77 with chronic hepatitis C) with reliable liver stiffness (LS) measurements, in whom we compared TE and VTQ to the LB performed during the same session (evaluated according to the Metavir scoring system: F0-F4). LS was assessed by TE (FibroScan, EchoSens, Paris, France) and VTQ using the Siemens Acuson S2000TM ultrasound system (Siemens AG, Erlangen, Germany). We defined reliable LS measurements as the median value of 10 measurements with an IQR/M

Background: Type 2 diabetes mellitus (T2DM), obesity, hyperlipidemia, and hypertension are considered risk factors for developing non-alcoholic fatty liver disease (NAFLD). This study aims to assess steatosis and fibrosis severity in a cohort of T2DM patients, using vibration controlled transient elastography (VCTE) and controlled attenuation parameter (CAP). Material and method: We performed a prospective study in which, in each patient, we aimed for 10 valid CAP and liver stiffness measurements (LSM). To discriminate between fibrosis stages, we used the following VCTE cut-offs: F &ge, 2&ndash, 8.2 kPa, F &ge, 3&ndash, 9.7 kPa, and F4 - 13.6 kPa. To discriminate between steatosis stages, we used the following CAP cut-offs: S1 (mild) &ndash, 274 dB/m, S2 (moderate) &ndash, 290dB/m, S3 (severe) &ndash, 302dB/m. Results: During the study period, we screened 776 patients, 60.3% had severe steatosis, while 19.4% had advanced fibrosis. Female gender, BMI, waist circumference, elevated levels of AST, total cholesterol, triglycerides, blood glucose, and high LSM were associated with severe steatosis (all p-value &lt, 0.05). BMI, waist circumference, elevated levels of AST, HbA1c, and CAP were associated with advanced fibrosis (all p-values &lt, 0.05). Conclusion: Higher BMI (obesity) comprises a higher risk of developing severe steatosis and fibrosis. Individualized screening strategies should be established for NAFLD according to different BMI.

Objectives: Chronic kidney disease is a rising cause of morbidity and mortality in developed countries, including end-stage renal disease (ESRD). The prevalence of thyroid comorbidities in persons with chronic kidney disease is documented higher than in normal population. The study aims to investigate the prevalence of morphological and functional thyroid disorders in patients with chronic kidney disease, with renal replacement therapy (hemodialysis). Methods: A cross-sectional study was performed on 123 consecutive patients with chronic kidney disease stage 5, on hemodialysis during a period of one month (May 2019–June 2020). All patients were enrolled for maintenance hemodialysis in B Braun Hemodialysis Center Timisoara and were examined on conventional 2B ultrasound. Thyroid blood tests were done, including serum free thyroxin (FT4), free triiodothyronine (FT3) and thyroid-stimulating hormone (TSH) at the time of starting hemodialysis. Results: We evaluated 123 patients (male to female ratio 70/53) mean age 62.2 ± 11.01, mostly above 65 years old, enrolled in the end-stage renal disease program, on renal replacement therapy. From the cohort, 76/123 presented thyroid disease, including autoimmune hypothyroidism, nodular goiter or thyroid cancer. Among them, 63 patients presented nodular goiter, including 3 thyroid cancers, confirmed by surgery and histopathological result, 22 patients had thyroid autoimmune disease. The serum thyroid-stimulating hormone levels found in the cohort was 3.36 ± 2.313 mUI/mL, which was in the normal laboratory reference range. The thyroid volume was 13 ± 7.18 mL. A single patient in the cohort presented Graves Basedow disease, under treatment and three patients present subclinical hyperthyroidism. We have found that thyroid disease risk is increased by 3.4-fold for the female gender and also the increase of body mass index (BMI) with one unit raises the risk of developing thyroid disease with 1.083 times (p = 0.018). Conclusion: To conclude, this study aimed to quantify the prevalence of thyroid disease in end-stage kidney disease population, especially nodular goiter, important for differential diagnosis in cases with secondary hyperparathyroidism. Thyroid autoimmune disease can be prevalent among these patients, as symptoms can overlap those of chronic disease and decrease the quality of life. We have found that thyroid disease has a high prevalence among patients with end-stage renal disease on hemodialysis. Thyroid goiter and nodules in ESRD patients were more prevalent than in the general population. Clinical surveillance and routine screening for thyroid disorders can improve the quality of life in these patients.

Given the increased prevalence of thyroid nodules in the general population (~50%), the real challenge resides in correctly recognizing the suspicious ones. This study proposes to compare four important Thyroid Imaging and Reporting Data Systems (TI-RADS) and evaluate the contribution of elastography and 4D Color Doppler assessment of vascularity in estimating the risk of malignancy. In the study, 133 nodules with histopathological examination were included. Of these, 35 (26.31%) proved to be malignant. All nodules were classified using the four selected systems and our proposed improved score. The American College of Radiology (ACR) and EU TI-RADS had good sensitivity (94.28%, 97.14%) and NPV (93.33%, 95.83%), but fairly poor specificity (31.81%, 23.46%) and PPV (35.48%, 31.19%), with an accuracy of 42.8% and 45.8%, respectively. Horvath TI-RADS had better accuracy of 66.9% and somewhat improved specificity (62.24%), but poorer sensitivity (80%). Russ’ French TI-RADS includes elastography in the risk assessment strategy. This classification proved superior in all aspects (Se: 91.42%, Sp:82.65%, NPV:96.42%, PPV:65.30%, and Acc of 84.96%). The mean strain ratio (SR) value for malignant lesions was 5.56, while the mean SR value for benign ones was significantly lower, 2.54 (p < 0.05). It also correlated well with the response variable: histopathological result (p < 0.001). Although, adding 4D vascularity to the French score generated a similar calculated accuracy and from a statistical point of view, the parameter itself proved beneficial for predicting the malignancy risk (p < 0.001) and may add important knowledge in uncertain situations. Advanced ultrasound techniques definitely improved the risk estimation and should be used more extensively.

Objectives. The aim of the study was to compare elastographic means in parathyroid adenomas, using shear wave elastography and strain elastography. Methods. This prospective study examined 20 consecutive patients diagnosed with primary hyperparathyroidism and parathyroid adenoma, confirmed by biochemical assay, technetium-99 sestamibi scintigraphy, and pathology report, after parathyroid surgery. All patients were examined on conventional 2B ultrasound, 2D shear wave elastography, and strain elastography. We determined using 2D shear wave elastography (SWE) the elasticity index (EI) in parathyroid adenoma, thyroid parenchyma, and surrounding muscle and examined using strain elastography the parathyroid adenoma, and determined the strain ratio with the thyroid tissue and muscle tissue. Results. All patients had positive sestamibi scintigraphy and underwent surgery, with confirmation of parathyroid adenoma in all cases. The mean parathormone (PTH) value before surgery was 153.29 pg/ml (36.5, 464.8) and serum calcium concentration was 10.5 mg/dl (9, 11.5). We compared using 2D-SWE and strain elastography parathyroid adenoma with thyroid tissue and with surrounding muscle. The mean EI measured by SWE in parathyroid adenoma was 4.74 ± 2.74 kPa and in thyroid parenchyma was 11.718 ± 4.206 kPa (mean difference = 6.978 kPa, p<0.001), and the mean EI value in muscle tissue was 16.362 ± 3.829 kPa (mean difference = 11.622, p<0.001). Using ROC analysis, we found that an EI below 7 kPa correctly identifies parathyroid tissue. We evaluated parathyroid adenomas using strain elastography by color mapping and strain ratio as a semiquantitative measurement; however, we could not find any statistical correlation comparing the strain ratio obtained from the parathyroid adenoma with the thyroid tissue (p=0.485). Conclusion. Ultrasound elastography is a helpful tool in identifying parathyroid adenomas. A cutoff value below 7 kPa can be used in 2D-SWE. Color maps in strain elastography without adding strain ratio can be used, parathyroid adenoma being identified as score 1 in the Rago criteria.

For more than 70 years, liver biopsy was considered the reference method to evaluate the severity of liver injury, but due to its shortcomings (invasive procedure, sampling variability, inhomogeneity, and interobserver variabilities), noninvasive alternatives have been sought. Ultrasound-based elastographic techniques have been used for almost 15 years. The most studied method is transient elastography (TE) that has been accepted by international guidelines as an alternative to liver biopsy for staging fibrosis, especially in chronic hepatitis C, and with promising results for predicting cirrhosis complications. Virtual Touch Quantification and point shear wave elastography (pSWE) have shown performance similar to TE for predicting significant fibrosis and cirrhosis. Newer elastographic techniques (two-dimensional [2D]-SWE from Supersonic Imagine and ElastPQ from Philips) have also shown promising results. Other elastographic techniques have been more recently released and are still under evaluation, including pSWE from Esaote and Hitachi as well as 2D-SWE from General Electric, Toshiba, and Philips. Despite the fact that strain elastography has been proven to be very useful for the evaluation of breast and thyroid nodules, its value for liver fibrosis assessment has yet to be demonstrated.

Background & Aims: Diverticular disease of the colon is a common clinical condition in developed countries, and is associated with significant (direct and indirect) economic burden. The aim of this Position Paper is to provide clinical guidance for appropriate definition, prevalence, risk factors, diagnosis, and treatment of colonic diverticular disease.Methods: A working group of recognized experts established by the Board of the Romanian Society of Gastroenterology and Hepatology (RSGH) screened the literature and the available guidelines on colonic diverticular disease. Statements were formulated based on literature evidence. These statements were discussed within the working group and decision for each of them was taken by consensus.Results: Thirty two statements were elaborated. The grade of recommendation, according to the level of evidence was established for each statement. Short comments with literature support accompany each statement.Conclusion: This Position Paper represents a practical guide for clinicians dealing with patients affected by colonic diverticular disease.

Gastric emptying and glycemic control pathways are closely interrelated processes. Gastric chyme is transferred into the duodenum with velocities depending on its solid or liquid state, as well as on its caloric and nutritional composition. Once nutrients enter the intestine, the secretion of incretins (hormonal products of intestinal cells) is stimulated. Among incretins, glucagon-like peptide-1 (GLP-1) has multiple glycemic-regulatory effects that include delayed gastric emptying, thus triggering a feedback loop lowering postprandial serum glucose levels. Glycemic values also influence gastric emptying; hyperglycemia slows it down, and hypoglycemia accelerates it, both limiting glycemic fluctuations. Disordered gastric emptying in diabetes mellitus is understood today as a complex pathophysiological condition, with both irreversible and reversible components and high intra- and interindividual variability of time span and clinical features. While limited delays may be useful for reducing postprandial hyperglycemias, severely hindered gastric emptying may be associated with higher glycemic variability and worsened long-term glycemic control. Therapeutic approaches for both gastric emptying and glycemic control include dietary modifications of meal structure or content and drugs acting as GLP-1 receptor agonists. In the foreseeable future, we will probably witness a wider range of dietary interventions and more incretin-based medications used for restoring both gastric emptying and glycemic levels to nearly physiological levels.

Objectives Point shear wave elastography is a quantitative ultrasound-based imaging method used in the assessment of renal disease. Among point shear wave elastographic options, 2 techniques have been studied considerably: Virtual Touch quantification (VTQ; Siemens AG, Erlangen, Germany) and ElastPQ (EPQ; Philips Healthcare, Bothell, WA). Both rely on the tissue response to an acoustic beam generated by the ultrasound transducer. The data on renal VTQ are more extensive, whereas EPQ has been used less thus far in the assessment of the kidneys. This study aimed to evaluate the performance of EPQ in the kidney and compare it with VTQ. Methods We studied 124 participants using EPQ: 22 with no renal disease and 102 with chronic kidney disease (CKD). Ninety-one were studied with both the EPQ and VTQ methods. We obtained 5 valid measurements in each kidney, expressed in meters per second. Results The mean kidney stiffness measurements ± SD obtained with EPQ in the healthy control group were as follows: right kidney, 1.23 ± 0.33 m/s; and left kidney, 1.26 ± 0.32 m/s (P = .6). In the patients with CKD (all stages), the mean kidney stiffness measurements obtained were significantly lower: right kidney, 1.09 ± 0.39 m/s; and left kidney, 1.04 ± 0.38 m/s (P = .4). We observed that, similar to VTQ, EPQ values decreased with CKD progression, based on analysis of variance results using different CKD stages. From a receiver operating characteristic curve analysis, the cutoff value for an estimated glomerular filtration rate of less than 45 mL/min was 1.24 m/s, and the value for an estimated glomerular filtration rate of less than 30 mL/min was 1.07 m/s. Conclusions When using EPQ, the kidney shear wave velocity is decreased in patients with CKD, an observation similar to that obtained by using the VTQ method.

Thyroid nodules are a common pathology found in 50 to 60% of otherwise healthy people. Diagnostic imaging techniques are help discriminating between benign and malignant nodules, while fine needle aspiration is still a gold standard. Shear wave elastography, a recent imaging technique, holds the promise to become reliable diagnostic tools and is currently used in combination with ultrasound. We here report data obtained in a series of 52 thyroid nodules analysed by means of elastography, as well as conventional and Doppler ultrasound. We found no differences in age, nodule and thyroid volume, length, width, thickness and maximum diameter between benign and malignant lesions. Several sonographic patterns are considered to be predictive of malignancy, out of which we only found the intranodular blood flow to be statistically significant. By the means of shear wave elastography we have first assessed tissue elasticities, which are shown in a range of colours, depending on tissue elasticity/stiffness. Then, we have measured and recorded four parameters automatically displayed by the system, namely SWE-mean, SWE-max, SWE-SD and SWE-ratio. Data analysis showed all these quantitative parameters had good sensitivity, specificity, positive predictive value, negative predictive value and area under the curve, as calculated by the ROC curve. As with these parameters, the cut-off points were lower than in literature, still able to indicate reliable diagnoses, which were confirmed by histopathological exam. Our conclusion is that shear wave elastography has great potential for reliably and accurately diagnosing thyroid malignancies.

BACKGROUND: Assessment of liver stiffness provides important diagnostic and prognostic information in patients with chronic liver disease. AIMS: To investigate whether the use of quality criteria (i) improves the concordance between transient elastography (TE) and a novel point shear wave elastography technique (ElastPQ®) and (ii) impacts on the performance of ElastPQ® for liver fibrosis staging using TE as the reference standard. METHODS: In this multicenter retrospective study, data of patients undergoing liver stiffness measurements (LSM) in five European centers were collected. TE was performed with FibroScan® (Echosens, France) and ElastPQ® with EPIQ® or Affiniti® systems (Philips, The Netherlands). The agreement between TE and ElastPQ® LSMs was assessed with Lin's concordance correlation coefficient (CCC). Diagnostic performance of ElastPQ® was assessed by the area under receiver operating characteristic (AUROC) curves. RESULTS: Overall, 664 patients were included: mean age: 54.8(13.5) years, main etiologies: viral hepatitis (83.1%) and NAFLD (7.5%). CCC increased significantly when LSMs with ElastPQ® were obtained with IQR/M ≤ 30% (p

CONTEXT: Nonalcoholic fatty liver disease is common in type 2 diabetes mellitus patients, being difficult to diagnose. OBJECTIVE: To find a correlation between elastographic parameters and lab results, for facilitating the diagnosis of nonalcoholic fatty liver disease. DESIGN: This is a cross sectional study, conducted at the Departments of Diabetes, Nutrition and Metabolic Diseases, and Gastroenterology and Hepatology, of the Clinical Emergency Hospital “Pius Brinzeu” Timisoara. SUBJECTS AND METHODS: We included 190 type 2 diabetes mellitus patients, collected data regarding medical history, clinical and biological features and applied the Alcohol Use Disorders Identification Test. We excluded patients with other causes of liver disease. Liver steatosis and fibrosis were evaluated through transient elastography, yielding two parameters: liver stiffness as an indicator of liver fibrosis stage, expressed in kPa, and liver steatosis stage, assessed by controlled attenuation parameter, expressed in dB/m. Data were analyzed using SPSS 15. RESULTS: The analyzed group comprised 113 patients. Elastographic measurements showed that 93.8% of the patients had steatosis (controlled attenuation parameter ≥232.5 dB/m) and 70.8% severe steatosis (controlled attenuation parameter ≥290 dB/m). Severe steatosis was more common in women (75.7%) than in men (68.1%) (p4 correlated with hepatic steatosis (p=0.04), being more common in patients with severe fibrosis/cirrhosis (58.3%) than in those with absent or mild fibrosis (36.2%). CONCLUSIONS: Our study found a clear correlation between type 2 diabetes mellitus and the presence of liver steatosis. It correlates with body mass index, waist circumference (in men) and triglycerides/HDLc ratio. Controlled attenuation parameter is a useful noninvasive method for detection and quantification of liver steatosis.

Aims: to evaluate the accuracy of LR-5 category from the latest Contrast-Enhanced Ultrasound algorithm (ACR CEUS LI-RADSv 2017) for the noninvasive diagnosis of hepatocellular carcinoma (HCC), in a real-life cohort of high-risk patients. Material and methods: We retrospectively re-analysed the CEUS studies of 464 focal liver lesions (FLL) in 382 patients at high-risk for HCC (liver cirrhosis of any aetiology, chronic B or C hepatitis with severe fibrosis) using the ACR CEUS LI-RADSv 2017 algorithm. CEUS LI-RADS categories used for the diagnosis of HCC were: CEUS LR-5 (definitely HCC) and CEUS LR-TIV (HCC with macrovascular invasion). Contrast-enhanced CT, contrast-enhanced MRI, or histology were used as diagnostic reference methods to evaluate the CEUS LI-RADS classification of the 464 lesions. Results: According to the reference method, the 464 lesions were classified as follows: 359 HCCs, 68 non-HCC-non-malignant lesions and 37 non- HCC malignant lesions. The diagnostic accuracy of LR-5 category for the diagnosis of hepatocellular carcinoma was 76.9%. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were 71.9%, 94.3 %, 97.7% and 49.5%, respectively. Conclusions: LR-5 category from ACR CEUS LI-RADSv 2017 algorithm, has good sensitivity, excellent specificity, and PPV for the diagnosis of HCC . The HCC rate increases from LR-3 to LR-5.

Background & Aims: Literature data suggest that HCV genotype-1b is present in 93-99% of the Romanian patients infected with hepatitis C virus (HCV). We present the genotyping tests recently performed on patients with HCV and advanced fibrosis eligible for the Direct-Acting Antiviral (DAA) therapy, as well as the prevalence of these cases across Romania.Methods: The genotyping method was performed on 7,421 HCV patients with advanced fibrosis. The detection method was automatic real time PCR platform M2000 (Abbott). Every subject was introduced into a database including age, sex, county and address.Results: Genotype 1b was almost exclusively present: 7,392/7,421 (99.6%). Genotype 1b patients were 19.6% from Bucharest, 49% were males, with a median age of 60 years. Genotype non-1b was encountered in 29/7,421 subjects (0.4%), 62% were males, 69% from Bucharest and the median age was 52 years. Most of the subjects (75%) were in the 6th and 7th age decade. The prevalence of these cases varied significantly across Romanian counties: the highest was in Bucharest (61.3/105), Bihor (47/105), Iasi (46/105) and Constanța (43/105), and the lowest in Ilfov (2.8/105), Harghita (3.7/105), Covasna (5.4/105) and Maramureș (8.8/105) (p

Background Direct antiviral agents (DAA) showed very good results in terms of efficacy and safety in clinical trials, but real-life data are still needed in order to confirm this profile. Material and methods In Romania, through a nationwide government-funded programme in 2015-2016, approx.5800 patients with virus C cirrhosis received fully reimbursed DAA therapy with OBV/PTV/r+DSV+RBV for 12 weeks. We analysed a national prospective cohort enrolling the first 2070 patients, all with genotype 1b. The only key inclusion criteria was advanced fibrosis (Metavir stage F4) confirmed by Fibromax testing (or liver biopsy/Fibroscan). Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12). Results Forty patients stopped the treatment because of hepatic decompensation (1.9%), 21 stopped because of other adverse events and one was lost to follow-up. This cohort was 51% females, mean age 60 years (25÷82), 67% pretreated, 70% associated NASH, 67% with severe necro-inflammation (severity score 3-Fibromax), 37% with comorbidities, 10.4% with Child Pugh A6, 0.5% B7. The median MELD score was 8.09 (6 ÷ 22). SVR by intention-to-treat was reported in 1999/2070(96.6%), 55/2070 failed to respond. Liver decompensation was statistically associated in multivariate analysis with platelets< 105/mm3(P = .03), increased total bilirubin (P

Background & Aims: Ombitasvir/Paritaprevir/ritonavir/Dasabuvir (OBV/PTV/r+DSV) is one of the elective direct-acting antivirals (DAAs) recommended by international guidelines and the only one covered by the National Insurance System in Romania until November 2016. Our aim was to present the first prospective Romanian cohort evaluating the effectiveness and safety in clinical practice of this 3DAA combination in patients with HCV genotype-1b Child A liver cirrhosis.Methods: 681 patients received OBV/PTV/r+DSV+RBV for 12 weeks and were assessed clinically and biologically at baseline, week 4, 8, 12 (end of treatment, EOT), and 12 weeks after therapy (sustained viral response, SVR).Results: Per protocol, EOT virological response was 99.8% and SVR12 rate was 99.4%. Adverse events were present in 36.4% of patients. Permanent discontinuation of 3DAA regimen due to side effects was reported in 11 patients (1.6%). In 47.6% (185/389) of patients, Transient Elastography values were >20kPa (defined as clinically significant portal hypertension, CSPH) at baseline. Independent variables associated with CSPH were: baseline cholesterol level (p=0.003), platelet count

Background & Aims: Liver stiffness (LS) measurement by Transient Elastography (TE) has been widely accepted as a tool for fibrosis assessment. The aim of this study was to assess LS dynamics in a group of patients with HCV liver cirrhosis after interferon free treatment (IFT).Methods: This two-center clinical trial included 225 patients with compensated HCV cirrhosis (all genotype 1b), who received IFT for 12 weeks. All patients were evaluated by means of TE at the beginning and at the end of treatment (EOT), and a subgroup (170 patients) also 12 weeks after EOT; all of them had sustained viral response (SVR). Reliable LS measurements (LSM) were defined as a median value of 10 valid LSM, with IQR