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Background. Adequate sedation is a prerequisite for quality endoscopic examination of the digestive tract. We aimed to evaluate the current practices and safety profile of sedation for gastrointestinal endoscopy in Romania and its impact on the technical success of the procedure and procedure-related adverse events. Methods. We conducted a prospective, multicentric, observational study including all patients undergoing digestive endoscopic procedures under various degrees of sedation. We collected data regarding the endoscopic procedure, type and degree of sedation, drug regimens, personnel in charge of sedation, and relevant patient related information. The main study outcome was the rate of sedation-related adverse events; secondary study outcomes included procedure-related adverse events and the impact of sedation on procedure success. Results. 1,043 consecutive endoscopic procedures from eight Romanian endoscopy units were included in our study. Sedation regimens were highly variable between participating centers, with 566 (54%) of procedures being performed under sedation provided by an anaesthesiologist. Sedation-related adverse events occurred in 40 cases (3.8%), most of them were mild respiratory and cardiovascular events and all reversed spontaneously. On multivariate analysis, male gender, procedure type (endoscopic ultrasound and endoscopic retrograde cholangiopancreatography) and deep sedation were risk factors for complications. The endoscopy unit, ASA status, age and type of sedative did not influence the complication rate. Conclusion. In conclusion, sedation for endoscopic procedures is generally safe, despite a high variability in sedation practices between centers in Romania. Establishing a national guideline on sedation for gastrointestinal endoscopy will ensure consistent and safe practice for these procedures.

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)

The study compared the diagnostic performance of two shear-wave elastography techniques, elastography point quantification (ElastPQ) and 2-D shear-wave elastography by General Electric (2-D-SWE.GE), for the non-invasive assessment of liver fibrosis in a cohort of patients with chronic hepatitis C virus (HCV) infection, using transient elastography (TE) as the reference method. There was no significant difference between the feasibility rates of TE, ElastPQ and 2-D-SWE.GE (p = 0.507). A good correlation was found between the liver stiffness (LS) values obtained using the two elastographic methods (r = 0.78). The mean LS values obtained using the ElastPQ technique were significantly higher than those obtained using 2-D-SWE.GE (12.1 ± 7.3 kPa vs. 10.4 ± 4.0 kPa, p0.0001). Pairwise comparisons of receiver operator characteristics curves between 2-D-SWE.GE and ElastPQ have shown that there are no significant differences in their performance for staging F ≥ 2 fibrosis (p = 0.89), F ≥ 3 fibrosis (p = 0.76) and F = 4 fibrosis (p = 0.86) in patients with chronic HCV infection.

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.

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.

Many ultrasound-based elastographic methods have been developed over the last decade with transient elastography (TE) being the first used for liver fibrosis assessment while later, point shear wave elastography (pSWE) and 2D-SWE were implemented in many ultrasound systems. Many studies used liver biopsy as “gold standard” for direct comparison between different elastographic methods. This chapter reviews the comparison studies between TE, pSWE, and 2D-SWE. In addition, comparative studies between ultrasound-based elastographic methods and magnetic resonance elastography (MRE) are discussed. Finally, advantages and limitations of the different elastographic methods are presented. In summary, many studies show similar feasibility and performance for the different ultrasound-based elastographic methods; however, different cutoff values should be used for the different systems. MRE seems to be superior to ultrasound-based techniques but is not yet readily available and expensive.

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.

Studies published so far using ultrasound-based elastography in the kidneys, lack to prove a clear relationship between kidney shear wave speed (KSWS) and renal disease progression. Taking into account that the kidney is a highly vascularized organ, the present study aims to find a relationship between KSWS and vascular factors (blood pressure [BP], arterial stiffness). Our study included 38 diabetic kidney disease patients (mean age 56.52 ± 16.12 years, 19 female, 19 male). KSWS, an indicator of renal stiffness, was measured using point Shear Wave Elastography (pSWE; Siemens Acuson S2000). In every patient, we recorded BP, and we measured aortic augmentation index (AAI) and brachial pulse wave velocity (PWV), using oscillometry. We found statistically significant indirect correlations of KSWS with indicators of arterial stiffness, such as PWV ( r = –.41, p = .036), and AAI ( r = –.37, p = .031). We found also an indirect correlation of KSWS with diastolic BP ( r = –.65, p = .02) and systolic BP ( r = –.54, p = .008). We found no correlation of KSWS with estimated glomerular filtration rate (eGFR), urinary albumin/creatinine ratio, stage of diabetic retinopathy, or glycated hemoglobin. Our study shows that high BP and the progression of arteriosclerosis (high PWV and AAI), leads to a decrease of renal stiffness. Thus, it seems that KSWS is influenced by renal blood flow, rather than other factors, such as albuminuria or chronic kidney disease stage.

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

We present here the first update of the 2013 EFSUMB (European Federation of Societies for Ultrasound in Medicine and Biology) Guidelines and Recommendations on the clinical use of elastography with a focus on the assessment of diffuse liver disease. The short version provides clinical information about the practical use of elastography equipment and interpretation of results in the assessment of diffuse liver disease and analyzes the main findings based on published studies, stressing the evidence from meta-analyses. The role of elastography in different etiologies of liver disease and in several clinical scenarios is also discussed. All of the recommendations are judged with regard to their evidence-based strength according to the Oxford Centre for Evidence-Based Medicine Levels of Evidence. This updated document is intended to act as a reference and to provide a practical guide for both beginners and advanced clinical users.Dies ist die erste Überarbeitung der 2013 publizierten EFSUMB-Leitlinien zur klinischen Anwendung der Elastografie und konzentriert sich auf die diffusen Lebererkrankungen. Der klinische Teil dieser Leitlinien erläutert die praktische Anwendung der Elastografie bei der Beurteilung diffuser Lebererkrankungen unter Berücksichtigung der Geräteausstattung und Interpretation der Ergebnisse. Die aktuelle Literatur wurde analysiert unter besonderer Beachtung von Metaanalysen. Die klinische Anwendung der Elastografie wird unter Reflexion unterschiedlicher klinischer Szenarien und der unterschiedlichen Ätiologien diffuser Lebererkrankungen erläutert. Alle Empfehlungen erfolgten gemäß der Evidenz basierten Methodik der Oxford-Klassifikation. Das hier vorgestellte Update soll dem Anfänger und fortgeschrittenen Nutzer eine praktische Hilfe darstellen.