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(1) Objective: To design an artificial intelligence system for prostate cancer prediction using the data obtained by shear wave elastography of the prostate, by comparing it with the histopathological exam of the prostate biopsy specimens. (2) Material and methods: We have conducted a prospective study on 356 patients undergoing transrectal ultrasound-guided prostate biopsy, for suspicion of prostate cancer. All patients were examined using bi-dimensional shear wave ultrasonography, which was followed by standard systematic transrectal prostate biopsy. The mean elasticity of each of the twelve systematic biopsy target zones was recorded and compared with the pathological examination results in all patients. The final dataset has included data from 223 patients with confirmed prostate cancer. Three machine learning classification algorithms (logistic regression, a decision tree classifier and a dense neural network) were implemented and their performance in predicting the positive lesions from the elastographic data measurements was assessed. (3) Results: The area under the curve (AUC) results were as follows: for logistic regression—0.88, for decision tree classifier—0.78 and for the dense neural network—0.94. Further use of an upsampling strategy for the training set of the neural network slightly improved its performance. Using an ensemble learning model, which combined the three machine learning models, we have obtained a final accuracy of 98%. (4) Conclusions: Bi-dimensional shear wave elastography could be very useful in predicting prostate cancer lesions, especially when it benefits from the computational power of artificial intelligence and machine learning algorithms.

Since nonalcoholic fatty liver disease (NAFLD) has become the leading cause of liver disease in the Western world, clinicians need reliable noninvasive tools for the identification of NAFLD-associated fibrosis. Limited evidence on the performance of the novel shear wave elastography technique Elast-PQ (EPQ) in NAFLD is available.In this prospective, European multinational study we assessed the diagnostic accuracy of EPQ using vibration-controlled transient elastography (VCTE) as a reference standard.Among 353 NAFLD patients, 332 (94.1%) fulfilled reliability criteria of VCTE and EPQ (defined by IQR/median ≤0.3; 41.3% female, mean age: 59 [IQR: 16.5], mean BMI: 29.0 (7.1)). 4/353 (1.1%) and 17/353 (4.8%) had unreliable VCTE and EPQ measurements, respectively. VCTE-based NAFLD fibrosis stages were F0/F1: 222(66.9%), F2: 41 (12.3%), F3: 30 (9.1%), F4: 39 (11.7%). We found a strong correlation (Pearson R=0.87; p0.0001) and concordance (Lin's concordance correlation coefficient =0.792) of EPQ with VCTE. EPQ was able to identify NAFLD-fibrosis risk with the following EPQ cutoffs: ≥6.5 kPa for significant fibrosis (≥F2) (≥1.47 m/s; sensitivity: 78%; specificity: 95%; AUROC: 0.94), ≥6.9 kPa for advanced fibrosis (≥F3) (≥1.52 m/s; sens.: 88%, spec.: 89%; AUROC: 0.949), and ≥10.4 kPa for cirrhosis (F4) (≥1.86 m/s; sens.: 87%; spec.: 94%; AUROC: 0.949).The point shear wave elastography technique EPQ shows excellent correlation to and concordance with VCTE. EPQ can reliably exclude NAFLD fibrosis6.0 kPa (1.41 m/s) and indicate a high risk of advanced fibrosis ≥10.4 kPa (≥1.86 m/s).Die nichtalkoholische Fettleber (NAFLD) ist mittlerweile die häufigste Lebererkrankung in der westlichen Welt. Daher besteht ein Bedarf an nichtinvasiven Methoden zur Einschätzung des Fibrose-Risikos bei NAFLD. Über die Aussagekraft der neue Scherwellen-Technologie Elast-PQ (EPQ) liegen nur wenige Daten vor.Diese prospektive, europäische multinationale Studie untersuchte die diagnostische Genauigkeit von EPQ bei NAFLD-PatientInnen im Vergleich zur Vibrations-kontrollierten transienten Elastografie (VCTE).Von 353 NAFLD-Patient*innen erfüllten 332 (94,1%) die Zuverlässigkeitskriterien für VCTE und EPQ (definiert als IQR/median ≤0,3). Die Studienpopulation war zu 41,3% weiblich, mit einem medianen Alter von 59 [IQR: 16,5] Jahren und einem medianen BMI von 29 [IQR: 7] kg/mDie Punkt-Scherwellen-Elastografie-Methode EPQ zeigt eine exzellente Korrektion und Konkordanz mit der VCTE. Bei NAFLD-Patient*innen wird durch EPQ6,0 kPa (1,41 m/s) eine signifikante Fibrose ausgeschlossen und durch EPQ ≥10,4 kPa (≥1,86 m/s) ein hohes Risiko für eine fortgeschrittene Fibrose angezeigt.

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.

Background: In patients with Hepatocarcinoma (HCC), the association between the rapid decline of kidney function and clinical outcomes is still unknown, although kidney-liver crosstalk is comprehensively studied. Objectives: We aimed to investigate the prevalence and determinants of the rapid decline of kidney function and its potential prognostic role and influence on mortality in HCC patients treated by percutaneous injection therapy (PEIT). Methods: This prospective cohort included 114 HCC, with 64.9% males and a mean age of 65.17 years. The rapid decline of kidney function was defined according to kidney disease improving global outcome (KDIGO). The cancer of the liver Italian program (CLIP) score was calculated to predict survival. Multivariable logistic regression analysis for rapid estimated glomerular filtration rate (eGFR) decline was performed after evaluating individual covariates. Multivariable Cox regression models for rapid eGFR decline and mortality were analyzed. Results: During a median follow-up of 31 months, 43.85% of patients presented a rapid decline in eGFR. The baseline eGFR was significantly higher in the group with the rapid decline of kidney function: 86.08 ± 19.17 mL/min/1.73m2 vs. 75.53 ± 25.7 mL/min/1.73 m2 (P = 0.001). The CLIP score (hazard ratio [HR] = 2.55, 95% confidence interval [CI]: 1.70 - 3.84, P < 0.001) was independently associated with rapid eGFR decline. In Cox regression, rapid eGFR decline was independently associated with mortality (HR = 3.49, 95%CI: 1.28 - 9.56, P = 0.015). Conclusions: Nearly half of the HCC patients presented a rapid eGFR decline. The HCC severity evaluated by the CLIP score was an independent predictor of the rapid decline of kidney function. The rapid decline in eGFR was associated with a higher mortality risk in HCC patients, independent of other known risk factors.

Non-invasive tests have been developed to determine the severity of liver disease in patients with alcohol use disorder (AUD). We aimed to assess the severity of liver steatosis and liver fibrosis (LF) in a cohort of patients with AUD using liver elastography and biological scores.Materials and methods: A prospective study was performed on 172 subjects, without previously known liver disease, with a positive AUDIT-C score, serum markers, and vibration-controlled transient elastography (VCTE) with Controlled Attenuation Parameter (CAP).Results: From 172 subjects with positive AUDIT-C test, VCTE diagnosed advanced fibrosis (F3) in 13.9% (24/172) of the subjects and liver cirrhosis (F4) in 17.5% (30/172). Moderate and severe steatosis was found in 18.6% (32/172), respectively 52.3% (90/172). Significant correlations were found between liver stiffness and APRI (r=0.33, p=0.001), FIB-4(r=0.31, p=0.0012) and the age-platelet index (r=0.25, p=0.008). FIB-4 (p=0.01) and age-platelet index (p=0.03) were independently associated with the presence of advanced fibrosis. Age-platelet index (AUC- 0.82) performed significantly better than AST/ALT (AUC- 0.55) and APRI (AUC- 0.58) (p= 0.0001 and p= 0.0014, respectively), but no differences were found when compared to FIB-4 (AUC- 0.77) (p=0.35) for predicting advanced fibrosis.Conclusion: In conclusion, in a cohort of patients with AUD, 70.9% presented moderate and severe liver steatosis and 17.5% were newly diagnosed with liver cirrhosis.

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.

The number of NAFLD patients is increasing in the developed world and non-invasive modalities for their evaluation are needed. Ultrasound-based methods are very useful for this approach, starting with standard ultrasound used for steatosis detection, and continuing with new modalities for steatosis, fibrosis, and inflammation quantification. Modern ultrasound systems can quantify all these parameters in NAFLD patients, thus making ultrasound a real Multiparameter Ultrasound (MPUS). The performance of ultrasound-based methods is very well documented with liver stiffness assessment as a marker of fibrosis, and more recently, for quantification of steatosis and viscoelastic properties as a marker of inflammation.

Shear-wave elastography (SWE) is widely used in thyroid evaluation, but multiple factors influence thyroid stiffness. Estimating tissue viscosity may enhance the ultrasound diagnosis of thyroid diseases, along with the ultrasound (US) and the SWE assessment. In order to be able to detect diffuse thyroid disease by viscosity measurements, it is essential to firstly define the normal values of thyroid viscosity in healthy subjects. Currently there are no published data on thyroid viscosity measurements. This first prospective study aimed to determine the normal range of thyroid viscosity values in a cohort of healthy thyroids, as well as to determine the factors that may influence them. One hundred and twenty-one consecutive subjects without thyroid pathology were evaluated in the study by means of conventional ultrasound, two-dimensional SWE (2D SWE PLUS) and viscosity plane-wave ultrasound (ViPLUS) embedded in the Supersonic MACH® 30 ultrasound system. Five valid tissue viscosity measurements were obtained for each thyroid lobe in every patient and the median values were analyzed and correlated with the biological and demographic parameters of each patient. Our results reveal that ViPLUS is a highly feasible and reproducible technique for thyroid evaluation. Thyroid stiffness, age, gender, BMI and depth of measurements did not influence the thyroid viscosity values. The mean thyroid viscosity by ViPLUS for normal thyroid tissue was of 2.42 ± 0.41 Pa·s. Viscosity assessment by Supersonic ViPLUS is an innovative, non-invasive technique that has proven to be useful for thyroid US evaluation and remains to demonstrate its effectiveness in identifying patients with thyroid disease.

The number of diabetes mellitus patients has increased over the last few years in developing countries, along with obesity and sedentary lifestyle. Besides macroangiopathy and microangiopathy, damage to the nerve fibers of the peripheral nervous system is the most common chronic complication of diabetes. Digestive complications in diabetic patients represent a consequence of diabetic autonomic neuropathy involving the gastrointestinal tract, but unfortunately not always evaluated by diabetologists. Aside from the complications encountered in the digestive tract, patients with diabetes mellitus are prone to developing liver diseases. This review will describe the prevalence of these complications, the modality of diagnosis, and therapeutical solutions in order to reduce the risk of progression of these complications in diabetic subjects.

Elastography is a useful noninvasive tool for the assessment of renal transplant recipients. 2D-shear wave elastography (SWE) PLUS and viscosity plane-wave ultrasound (Vi PLUS) have emerged as novel techniques that promise to offer improved renal stiffness and viscosity measures due to improved processing algorithms. Methods: We performed a cross-sectional study of 50 kidney transplanted patients (16 women, 34 men; mean age of 47.5 ± 12.5; mean estimated glomerular filtration rate (eGFR) estimated by Chronic Kidney Disease Epidemiology Collaboration formula: 52.19 ± 22.6 mL/min/1.73 m2; and a mean duration after transplant of 10.09 ± 5 years). For every patient, we obtained five valid measurements of renal stiffness (obtained from five different frames in the cortex of the renal graft), and also tissue viscosity, with a C6-1X convex transducer using the Ultra-Fast™ software available on the Aixplorer Mach 30 ultrasound system (Supersonic Imagine, Aix-en-Provence, France). The median values of elastographic and viscosity measures have been correlated with the patients’ demographic, biological, and clinical parameters. Results: We obtained a cut-off value of renal cortical stiffness of

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.

The aim was to evaluate the performance of 2-dimensional (2D) shear-wave elastography from general electric (2D SWE-GE), implemented on the new LOGIQ S8 system, for the noninvasive assessment of liver fibrosis, and to identify liver stiffness (LS) cutoff values for predicting different stages of fibrosis using transient elastography (TE) as the control method. We included 179 consecutive subjects, with or without chronic hepatopathies, in whom LS was evaluated in the same session using 2 elastographic techniques: TE (FibroScan, EchoSens) and 2D SWE-GE (LOGIQ S8; GE Healthcare, Chalfont St Giles, United Kingdom). Reliable LS measurements were defined for TE: the median value of 10 measurements with a success rate of 60% or greater and an interquartile range/median ratio (IQR/M) < 0.30; for 2D SWE-GE: the median value of 10 measurements acquired in a homogenous area and IQR/M < 0.30. To discriminate between fibrosis stages by TE, we used the following cutoffs: F2-7; F3-9.5 and F4-12 kPa. Reliable LS measurements were obtained in 97.2% subjects by 2D SWE-GE and in 98.3% by TE (P = 0.72), so that 171 subjects were included for the final analysis. A good correlation was found between the LS values obtained by the 2 methods (r = 0.72, P < 0.0001). The best 2D SWE-GE cutoff value for F ≥ 2 was 6.9 kPa (areas under receiver operating characteristic [AUROC], 0.93; sensitivity, 85.8%; specificity, 90.2%), for F of 3 or greater, it was 8.2 kPa (AUROC, 0.93; sensitivity, 87.5%; specificity, 86.8%) and for F value of 4, it was 9.3 kPa (AUROC, 0.91; sensitivity, 85.7%; specificity, 81.2%). In conclusion, the best 2D SWE-GE (S8) cutoff values for predicting F2, F ≥ 3 and F = 4 were 6.9, 8.2, and 9.3 kPa.

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

The present, updated document describes the fourth iteration of recommendations for the hepatic use of contrast enhanced ultrasound (CEUS), first initiated in 2004 by the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB). The previous updated editions of the guidelines reflected changes in the available contrast agents and updated the guidelines not only for hepatic but also for non-hepatic applications.The 2012 guideline requires updating as previously the differences of the contrast agents were not precisely described and the differences in contrast phases as well as handling were not clearly indicated. In addition, more evidence has been published for all contrast agents. The update also reflects the most recent developments in contrast agents, including the United States Food and Drug Administration (FDA) approval as well as the extensive Asian experience, to produce a truly international perspective.These guidelines and recommendations provide general advice on the use of ultrasound contrast agents (UCA) and are intended to create standard protocols for the use and administration of UCA in liver applications on an international basis to improve the management of patients.

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.

This study aims to evaluate the performance of contrast-enhanced ultrasound (CEUS) and biological tests to characterize portal vein thrombosis (PVT). We retrospectively analyzed 101 patients with PVT, liver cirrhosis, and hepatocellular carcinoma (HCC). In all patients, demographic, biologic, imaging, and endoscopic data were collected. All patients underwent CEUS and a second line imaging technique (CE-CT/MRI) to characterize PVT. Of the 101 cirrhotic subjects, 77 (76.2%) had HCC. CEUS had 98.6% sensitivity (Se) and 89.3% specificity (Sp) for the characterization of PVT type. A significant correlation was found between alpha-fetoprotein (AFP) levels and the PVT characterization at CEUS (r = 0.28, p = 0.0098) and CT/MRI (r = 0.3, p = 0.0057). Using the AFP rule-out cutoff values for HCC (AFP < 20 ng/dL), 78% of the subjects were correctly classified as having benign PVT, while 100% of the subjects were correctly classified as tumor-in-vein (TIV) when the rule-in cutoff value was used (AFP ≥ 200 ng/dL). Using multiple regression analysis, we obtained a score for classifying PVT. The PVT score performed better than CEUS (AUC—0.99 vs. AUC—0.93, p = 0.025) or AFP serum levels (AUC—0.99 vs. AUC—0.96, p = 0.047) for characterizing PVT. In conclusion, CEUS is a sensitive method for the characterization of PVT. The PVT score had the highest performance for PVT characterization.

Malnutrition and sarcopenia are common complications of liver cirrhosis. This study compares the performance of different nutritional assessment techniques in detecting malnourished patients. Data from 156 patients with liver cirrhosis were collected. We assessed the nutritional status of these patients according to: Subjective Global Assessment (SGA); Royal Free Hospital-Nutritional Prioritizing Tool (RFH-NPT), skinfold thickness (TSF), mid-upper arm circumference (MUAC), mid-upper arm muscle circumference (MUMC), handgrip strength (HGS), body mass index (BMI), and skeletal muscle index (SMI) evaluated by Contrast-Enhanced Computed Tomography (CT). According to EWGSOP2 criteria, combining low HGS with low SMI, the prevalence of malnutrition/sarcopenia was 60.2%. RFH-NPT, MUAC, MAMC, and HGS were excellent tests for detecting malnourished patients. Combining RFH-NPT with MUAC or MUMC increased diagnosis accuracy, AUC = 0.89, p < 0.0001. Age, Child-Pugh class C, albumin level, vitamin D deficiency, male gender, and alcoholic etiology were significantly associated with malnutrition. In conclusion, the prevalence of malnutrition among patients with cirrhosis was relatively high. Our study highlights the potential use of a simpler and inexpensive alternative that can be used as a valuable tool in daily practice, the combination between RFH-NPT and MUAC.

Ruxandra Mare,1,2 Ioan Sporea,1,2 Mirela Tomescu,3 Gheorghe Nicușor Pop,3 Andrei Vitel,3 Alina Popescu,1,2 Silviu Nistorescu,1 Roxana Sirli1,2 1Department of Internal Medicine II, Gastroenterology and Hepatology Unit, Advanced Research Center in Gastroenterology and Hepatology “Victor Babes” University of Medicine and Pharmacy, Timisoara, Romania; 2Regional Center of Research in Advanced Hepatology, Academy of Medical Science, Timisoara, Romania; 3Department VI of Cardiology, “Victor Babeș” University of Medicine and Pharmacy, Timisoara, RomaniaCorrespondence: Roxana Sirli, Department of Internal Medicine II, Gastroenterology and Hepatology Unit, Advanced Research Center in Gastroenterology and Hepatology “Victor Babes” University of Medicine and Pharmacy, Timisoara, Romania, Tel +40723537039, Fax +40723537039, Email roxanasirli@gmail.comIntroduction: Many of the patients presenting with metabolic syndrome (MetS) also have liver steatosis (NAFLD) and some of them could develop liver fibrosis.Purpose: To develop a simple score that could rule out fibrosis, especially significant fibrosis (F≥ 2) and could be used in daily practice in patients with MetS, in order to identify patients at risk.Patients and Methods: A total of 204 patients with MetS were prospectively enrolled. Evaluation of liver fibrosis was made using Vibration Controlled Transient Elastography while evaluation of steatosis was achieved using ultrasound (US).Results: Out of 204 patients with MetS, 179 patients (87.7%) had reliable liver stiffness measurements and 22.9% (41/179) had F ≥ 2. To formulate the fibrosis predicting score, all clinical variables associated with F ≥ 2 in the univariate analysis were considered in a multivariate regression model. According to the power of correlation, by consensus, we attributed 1 point for BMI > 31.4 kg/m2, 1 point for female gender, 1 point for HDLc < 47mg/dL, 1 point for mild steatosis at US, 1.5 point for moderate and 2 points for severe steatosis.Conclusion: At an optimal cut-off value of < 3.5, our score could be used to rule-out the risk for developing at least significant fibrosis with a high negative predictive value (NPV 89.2%) in patients with MetS.Keywords: metabolic syndrome, liver steatosis, liver fibrosis, liver elastography

Background: Changing the term/concept of the non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction associated fatty liver disease (MAFLD) may broaden the pathological definition that can include chronic renal involvement, and, possibly, changes chronic kidney disease's (CKD's) epidemiological association with liver disease, because CKD is associated with metabolic disorders and almost all patients with CKD present some form of an atherogenic dyslipidemia. Our study explores the relationship between MAFLD and CKD using Transient Elastography (TE) with a Controlled Attenuated Parameter (CAP).Methods: We evaluated 335 patients with diabetes with MAFLD and with high CKD risk using TE with CAP (FibroScan®). The CKD was defined according to Kidney Disease Improving Global Outcomes (KDIGO) 2012 guidelines. Logistic regression and stepwise multiple logistic regression were used to evaluate the factors associated with CKD. In addition, a receiver operating characteristic curve (ROC) analysis was used to assess the performance of CAP and TE in predicting CKD and its optimal threshold.Results: The prevalence of CKD in our group was 60.8%. Patients with CKD had higher mean liver stiffness measurements (LSM) and CAP values than those without CKD. We found that hepatic steatosis was a better predictor of CKD than fibrosis. Univariate regression showed that CAP values >353 dB/m were predictive of CKD; while the multivariate regression analysis (after adjustment according to sex, body mass index (BMI), low-density lipoprotein cholesterol (LDLc), and high-density lipoprotein cholesterol (HDLc), and fasting glucose) showed that CAP values >353 dB/m were more strongly associated with the presence of CKD compared to the LSM (fibrosis) values.Conclusion: In patients with MAFLD, CAP-assessed steatosis appears to be a better predictor of CKD compared to LSM-assessed hepatic fibrosis.

Background and Aims: Gastroesophageal reflux disease (GERD) is a common condition present in daily practice with a wide range of clinical phenotypes. In this line, respiratory conditions may be associated with GERD. The Romanian Societies of Gastroenterology and Neurogastroenterology, in association with the Romanian Society of Pneumology, aimed to create a guideline regarding the epidemiology, diagnosis and treatment of respiratory conditions associated with GERD.Methods: Delphi methodology was used and eleven common working groups of experts were created. The experts reviewed the literature according to GRADE criteria and formulated 34 statements and recommendations. Consensus (>80% agreement) was reached for some of the statements after all participants voted.Results: All the statements and the literature review are presented in the paper, together with their correspondent grade of evidence and the voting results. Based on >80% voting agreement, a number of 22 recommendations were postulated regarding the diagnosis and treatment of GERD-induced respiratory symptoms. The experts considered that GERD may cause bronchial asthma and chronic cough in an important number of patients through micro-aspiration and vagal-mediated tracheobronchial reflex. GERD should be suspected in patients with asthma with suboptimal controlled or after exclusion of other causes, also in nocturnal refractory cough which needs gastroenterological investigations to confirm the diagnosis. Therapeutic test with double dose proton pump inhibitors (PPI) for 3 months is also useful. GERD induced respiratory conditions are difficult to treat; however,proton pump inhibitors and laparoscopic Nissen fundoplication are endorsed for therapy.Conclusions: This guideline could be useful for the multidisciplinary management of GERD with respiratory symptoms in current practice.

Various statistical models predict the probability of developing hepatocellular carcinoma (HCC) in patients with cirrhosis, with GALAD being one of the most extensively studied scores. Biomarkers like alpha-fetoprotein (AFP), AFP-L3, and des-g-carboxyprothrombin (DCP) are widely used alone or in conjunction with ultrasound to screen for HCC. Our study aimed to compare the effectiveness of Cytokeratin 19 (CK19) and Glypican-3 (GPC3) as standalone biomarkers and in a statistical model to predict the likelihood of HCC. We conducted a monocentric prospective study involving 154 participants with previously diagnosed liver cirrhosis, divided into two groups: 95 patients with confirmed HCC based on clinical, biological, and imaging features and 59 patients without HCC. We measured the levels of AFP, AFP-L3, DCP, GPC3, and CK19 in both groups. We used univariate and multivariate statistical analyses to evaluate the ability of GPC3 and CK19 to predict the presence of HCC and incorporated them into a statistical model—the GALKA score—which was then compared to the GALAD score. AFP performed better than AFP-F3, DCP, GPC3, and CK19 in predicting the presence of HCC in our cohort. Additionally, GPC3 outperformed CK19. We used multivariate analysis to compute the GALKA score to predict the presence of HCC. Using these predictors, the following score was formulated: 0.005*AFP-L3 + 0.00069*AFP + 0.000066*GPC3 + 0.01*CK19 + 0.235*Serum Albumin—0.277. The optimal cutoff was >0.32 (AUROC = 0.98, sensitivity: 96.8%, specificity: 93%, positive predictive value—95.8%, negative predictive value—94.8%). The GALKA score had a similar predictive value to the GALAD score for the presence of HCC. In conclusion, AFP, AFP-L3, and DCP were the best biomarkers for predicting the likelihood of HCC. Our score performed well overall and was comparable to the GALAD score.

The estimation of viscosity by measuring the shear-wave dispersion (SWD) using ultrasound 2D shear-wave elastography (SWE) is becoming more and more popular. Recent research suggests that SWD can be used in addition to 2D-SWE (shear-wave speed) to diagnose diffuse liver disease. Viscosity was studied for the assessment of normal thyroid tissue. This study aims to evaluate the use of viscosity measurements in patients with chronic autoimmune thyroiditis using the SuperSonic MACH®30 ultrasound machine (Hologic SuperSonic Imagine, Aix-en-Provence, France) which provides the Vi PLUS mode for viscosity and the 2D SWE PLUS mode for shear-wave speed measurements. Valid measurements were obtained in 308 cases, 153 with chronic autoimmune thyroiditis (CAT) and 155 with no thyroid pathology (95.95% feasibility of the methods). The differences between the healthy group and the CAT group were statistically significant both for Vi PLUS (2.5 ± 0.4 vs. 2.8 ± 0.5, p < 0.0001) and for 2D-SWE PLUS (13.5 ± 3.3 vs. 23.1 ± 8.3, p < 0.0001). The diagnostic performance was poor for Vi PLUS alone (AUC = 0.69; cut-off > 2.5 Pa·s, se = 68.6%; sp = 64.52%) and good for 2D-SWE PLUS alone (AUC = 0.861; cut-off > 18.4 kPa, se = 69.9%; sp = 92.2%). Vi PLUS correlated with 2D-SWE PLUS, with the presence of CAT, the thyroid volume, levothyroxine replacement therapy and age. Statistically significant differences were found between the CAT subgroup receiving thyroid replacement therapy and the subgroup without therapy: 24.74 ± 8.33 vs. 21.93 ± 8.12 kPa for 2D-SWE (p = 0.0380) and 3 ± 0.5 vs. 2.7 ± 0.4 Pa·s for Vi PLUS (p = 0.0193). Elastography-based methods improve the classic ultrasound evaluation: 2D-SWE PLUS performed somewhat better in distinguishing CAT from normal thyroid tissue, while Vi PLUS made a slightly better assessment regarding the functional status.

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.

Acute upper gastrointestinal bleeding (UGIB) is a typical medical emergency, with an incidence of 84 to 160 cases per 100,000 individuals and a mortality rate of approximately 10%. This study aimed to identify all cases of UGIB hospitalized in a tertiary gastroenterology department, to identify possible predictive factors involved in rebleeding and mortality, potential associations between different elements and the severity of bleeding, and the differences between the upper digestive hemorrhage due to nonvariceal and variceal bleeding. This was an observational, retrospective study of patients with UGIB admitted to the tertiary Department of Gastroenterology between January 2013 and December 2020. A total of 1499 patients were enrolled in the study. One thousand four hundred and ninety-nine patients were hospitalized for 7 years with active upper digestive hemorrhage, 504 variceal bleeding, and 995 nonvariceal bleeding. When comparing variceal with nonvariceal bleeding, in nonvariceal bleeding, the mean age was higher, similar sex, higher mortality rate, higher rebleeding rate, and higher hemorrhagic shock rate. Endoscopy treatment was also performed more frequently in variceal bleeding than in nonvariceal bleeding. Severe anemia was found more frequently in patients with variceal bleeding. The mortality rate was 10% in the entire study group, which was not significantly different between the 2 batches. However, the rebleeding rate is higher in patients with variceal gastrointestinal bleeding.

The aim of this study is to assess the diagnostic performance of strain elastography (SE) versus 2D shear-wave elastography (2D-SWE) by providing a head-to-head comparison of the two methods. Ninety-four thyroid nodules were evaluated using conventional ultrasound (B-mode) and SE, namely, real-time elastography (RTE) with a Hitachi Preirus machine (Hitachi Inc., Tokyo, Japan) and consecutively, 2D-SWE with SuperSonic Mach30 equipment (Supersonic Imagine, Aix-en-Provence, France). The results were compared in all cases to the pathology reports. Out of the 94 nodules, 29 (30.9%) were malignant. Both SE and 2D-SWE parameters proved to have excellent diagnostic quality, with comparable results. The mean elasticity index was the best parameter for the 2D-SWE (AUC 0.912); for a cut-off value of 30.5 kPa, it predicts thyroid malignancy with a sensitivity of 79.3%, specificity of 95.38%, NPV of 91.2% and PPV of 88.5%. The best parameter for SE was the strain ratio (cutoff > 3.9; sensitivity 82.7%; specificity 92.3%; AUC 0.905). When integrated in the ultrasound risk algorithm, both elastography methods improved the diagnostic performance: AUC 0.764 vs. 0.886 vs. 0.861 for B-modes: B-mode + 2D-SWE vs. B-mode + SE. We concluded that elastography adds diagnostic value in predicting malignancy, both when Hitachi RTE and SuperSonic 2D-SWE were used.

This manuscript describes the use of ultrasound elastography, with the exception of liver applications, and represents an update of the 2013 EFSUMB (European Federation of Societies for Ultrasound in Medicine and Biology) Guidelines and Recommendations on the clinical use of elastography.Diese Arbeit beschreibt den Einsatz der Ultraschall-Elastografie mit Ausnahme der Leberanwendungen und ist eine Aktualisierung der Leitlinien und Empfehlungen der EFSUMB (European Federation of Societies for Ultrasound in Medicine and Biology) von 2013 zum klinischen Einsatz der Elastografie.

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.