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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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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

The aim of the paper was to propose a score for performance evaluation in colonoscopy units. Method. We proposed a score ( CDCD score - C ecal intubation, polyp D etection rate, C leansing and D ocumentation of cecal intubation) based on the following parameters that assess the quality of colonoscopy units: total colonoscopies rate, polyp detection rate, rate of cecal intubation photo record, rate of recorded Boston bowel preparation scale (BBPS) (rated 1 to 5 stars). The mean score obtained based on the above mentioned criteria was used as a quality parameter of the endoscopy unit. We applied and calculated this score in all screening colonoscopies performed in our Endoscopy Department during the last 4 years. Results. The study group included 856 screening colonoscopies. The rate of total colonoscopies was 92.1% (789/856 cases) and the polyp detection rate was 23.9%. Regarding the quality of bowel preparation, the BBPS was recorded in 51.1% cases. The cecal intubation was photo recorded in 44% of cases. We considered that of the 4 parameters, the highest weight for an excellent quality belonged to the cecal intubation rate, followed by the polyp detection rate, because they evaluate the endoscopic technique, while the other 2 are more administrative. Thus, for the unit’s assessment we used the following equation: UNIT’S QUALITY CDCD SCORE = (3xcecal intubation rate+3xpolyp detection rate+1xphoto documentation+1xBBPS documentation)/8. Thus, the CDCD Score for our unit was ≈4 stars (3.7 stars). Conclusion. the proposed CDCD score may be an objective tool for the quality assessment in different endoscopy units.

Hepatic (biliary) cystic tumor (HBCT) is a rare focal cystic liver lesion, which has been rarely described in the literature. In our current multicenter, retrospective study, we aimed to analyze contrast enhanced ultrasound (CEUS) features and its diagnostic performance in histologically proved HBCT.Twenty-three patients with single HBCT were retrospectively analyzed. Histologically, 17 (73.9%) were benign hepatic (biliary) cystadenoma (HBCA), 6 (26.1%) were hepatic (biliary) cystadenocarcinoma (HBCAC). All CEUS examinations were assessed by two independent radiologists in consensus. Criteria of CEUS imaging evaluation included the contrast enhancement pattern of lesion (hypoenhancing, hyperenhancing, isoenhancing in comparison to the surrounding liver parenchyma) during the arterial, portal venous and late phases.After injection of ultrasound contrast agents, most of the HBCTs (78.3%, 18/23) had typical honeycomb enhancement pattern of the cystic wall, septa or mural nodules. Comparing between HBCA and HBCAC, hyperenhancement of the honeycomb septa during the arterial phase was more common in HBCA (p = .047). However, hypoenhancement during the portal venous and late phases was the characteristic of HBCAC (p = .041).The EFSUMB algorithm for CEUS for characterization of solid focal liver lesions is also applicable to HBCT. CEUS evaluation can avoid further diagnostic investigations or invasive biopsy procedure.

Nonalcoholic liver disease (NAFLD) is a hot topic for gastroenterologists and hepatologists and clinical practitioners must be kept abreast with the rapid progress of knowledge in this field. The Romanian Society of Gastroenterology and Hepatology (RSGH) has elaborated this review dedicated to evidence-based data on pathogenesis, diagnosis and therapy of this condition. The term NAFLD includes two distinct conditions, with different histologic features and prognosis: non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH), the second with the highest risk of evolution to cirrhosis and its complications, including hepatocellular carcinoma (HCC). Non-alcoholic fatty liver disease is considered the hepatic manifestation of the metabolic syndrome. Therefore, NAFLD is associated not only with an increase of liver-related mortality, but also of the overall mortality, especially cardiovascular and malignancies. Noninvasive techniques, such as biological tests and elastography can be used for the evaluation of NAFLD patients. Liver biopsy should be recommended in selected cases, for diagnostic, therapeutic and prognostic purposes. Patients with NAFLD would benefit from their lifestyle changes by progressive weight loss through exercise and low fat and sugar diet. Pharmacotherapy should be reserved for patients with NASH, particularly for those with significant fibrosis. Until now, there are no FDA approved therapies for NASH.

Management of patients undergoing endoscopy and under treatment with the newer direct oral anticoagulants (DOACs) is a common and a complex clinical issue that gastroenterologists have to face more and more often these days. The increasing use of DOACs in patients requiring both short- and long-term anticoagulation is mostly due to the advantages these agents offer, among which the lack of monitoring requirements and the reduced need of dose adjustments are perhaps the most important ones. Managing these patients in the peri-endoscopic period implies balancing the risk for thrombosis that a certain patient carries and the bleeding risk associated with the endoscopic procedure itself. The Romanian Society of Gastroenterology and Hepatology decided to create a consensus paper to serve to practitioners and teachers. After reviewing the available published data and existing recommendations, a Delphi consensus process was carried out involving the leaders of opinion in this field. After reaching expert consensus, we provide herein guidance for a practical approach of DOACs therapy management in patients with endoscopic interventions.

The aim of the study was to assess the severity of liver fibrosis and steatosis in a cohort of type 2 diabetic patients, using non-invasive Methods: Transient Elastography (TE) and Controlled Attenuation Parameter (CAP). Material and Method: The study included 704 type 2 diabetic patients prospectively randomized, evaluated in the same session by means of TE and CAP (FibroScan, EchoSens) to assess both liver fibrosis and steatosis. Reliable liver stiffness measurements (LSM) were defined as the median value of 10 LSM with an IQR/median 300 db/m. Results: Out of 704 diabetics screened we excluded those with associated viral hepatitis, those with an AUDIT-C score ≥ 8 and those with unreliable LSM. The final analysis included 485 subjects (54.3% women, mean age 60 ± 9.5; mean BMI = 31.6 ± 6.1 kg/m2) with reliable LSM. 32.1% of patients had obesity grade I, 17.9 % had obesity grade II and 8.9% had obesity grade III (IMC ≥ 40 kg/m2). Mild, moderate and severe steatosis by means of CAP was found in 15.6%, 15.6 % and 59.3% cases, respectively. The median CAP values of patients with mild, moderate and severe steatosis were 260 db/m, 287.5 db/m and 354 db/m. Clinically relevant fibrosis was detected by means of TE in 19.6% (95/485) of subjects. Conclusion: In our group, 59.3% of diabetic patients had severe steatosis by means of CAP. Regarding the liver fibrosis, we found that 19.6% of them had severe fibrosis (TE ≥ 10.1kPa), suggesting the need for further assessment.

Background: Hepatitis delta virus (HDV) infection is associated with accelerated progression of fibrosis, early occurrence of hepatic decompensation and an increased risk for hepatocellular carcinoma. Epidemiological data on hepatitis delta virus (HDV) in Romania are still lacking. Aim: To assess the prevalence, virological, clinical and epidemiological features of HDV infection in Romanian patients. Methods: We conducted a multicenter study in 10 centers. Data on sociodemographic characteristics and potential risk factors were collected through a questionnaire. Virological markers of HBV and HDV infection, biochemical and clinical features of liver disease were evaluated. Results: The study population comprised 2,761 HBsAg(+) patients with a mean age of 43.8±13.8 years, out of whom 5.2% were HBeAg(+) and 55.7% were males. Liver cirrhosis was detected in 17.9% of patients, while 80.4% had chronic hepatitis. The prevalence of IgG anti-HDV(+) patients was 23.1%, out of whom 16.4% were HDV RNA positive. The highest prevalence of HDV infection was encountered in patients aged 50-59 years (28.9%) and patients aged ≥60 (24.8%) (p=0.0001). Seroprevalence of HDV was significantly higher in AgHBs(+) cirrhotics vs. noncirrhotics (43.4% vs 19.0%, p=0.0001). Risk factors for HDV infection were: occupational hazard, no HCV chronic infection, lack of anti-HBV vaccination, presence of blood transfusions, any previous surgery, frequent hospitalization or endoscopies, tattoos, body piercing, use of glass syringes, number of female sexual partners. Conclusions: HBsAg(+) population in Romania is characterized by a high prevalence of HBeAg(-) HBV infection as well as HDV co-infection. A cohort phenomenon for HDV prevalence is also observed similar to that of HCV/HBV monoinfections.

To evaluate and compare the values of the elasticity index as measured by shear wave elastography in healthy subjects and in patients with autoimmune thyroid disease, in order to establish if this investigation can predict the occurrence of autoimmune thyroid disease. A total of 104 cases were included in the study group: 91 women (87.5 %), out of which 52 (50 %) with autoimmune thyroid disease diagnosed by specific tests and 52 (50 %) healthy volunteers, matched for age and gender. For all the subjects, three measurements were performed on each thyroid lobe and a mean value was calculated. The data were expressed in kPa. The investigation was performed with an Aixplorer system (SuperSonic Imagine, France), using a linear high-resolution 15-4 MHz transducer. The mean value for the elasticity index was similar in the right and the left thyroid lobes, both in normal subjects and in patients with autoimmune thyroid disease: 19.6 ± 6.6 vs. 19.5 ± 6.8 kPa, p = 0.92, and 26.6 ± 10.0 vs. 25.8 ± 11.7 kPa, p = 0.71, respectively. This parameter was significantly higher in patients with autoimmune thyroid disease than in controls (p

Hepatitis B virus may reactivate in patients with chronic hepatitis C treated with direct-acting antivirals. The aim of this study was to investigate the risk of hepatitis B virus (HBV) reactivation in HBV + hepatitis C virus (HCV)-co-infected patients with compensated liver cirrhosis treated with paritaprevir/ombitasvir/ritonavir, dasabuvir with ribavirin. We reviewed prospectively gathered data from a national cohort of 2070 hepatitis C virus patients with compensated liver cirrhosis who received reimbursed paritaprevir/ombitasvir/r, dasabuvir with ribavirin for 12 weeks from the Romanian National Health Agency during 2015-2016. Twenty-five patients in this cohort were HBs antigen positive (1.2%); 15 untreated with nucleotide analogues agreed to enter the study. These patients were followed up: ALT monthly, serology for HBV and DNA viral load at baseline, EOT and SVR at 12 weeks. Hepatitis B virus (HBV)-co-infected patients were all genotype 1b and 52% females, with a median age of 60 years (51 ÷ 74); 76% were pretreated with peginterferon + ribavirin; 72% were with severe necroinflammatory activity on FibroMax assessment; 40% presented comorbidities; and all were HBe antigen negative. Hepatitis C virus (HCV) SVR response rate was 100%. Hepatitis B virus (HBV)-DNA viral load was undetectable in 7/15 (47%) before therapy, and for the other 8 patients, it varied between below 20 and 867 IU/mL. Five patients (33%) presented virological reactivation (>2 log increase in HBV-DNA levels) during therapy. One patient presented with hepatitis associated with HBV reactivation, and two started anti-HBV therapy with entecavir. Hepatitis B virus (HBV) virological reactivation was present in 33% in our patients. Generally, HBV-DNA elevations were mild (

Background & Aims: Hepatitis C virus (HCV) infection is a common condition with endemic prevalence in some areas of the world. In Romania, the mean prevalence is about 3%. New treatments have become available on the market in recent years and new drugs are in the pipeline. A re-evaluation of HCV therapy was considered mandatory. The Romanian Society of Gastroenterology and Hepatology undertook this task for the practitioners of this country.Methodology: A group of recognized experts was created who screened the available literature and the major available guidelines. A list of items requiring attention was created and these were discussed and rated. Decisions were taken by consensus.Recommendations: We present here the second part of the Society’s recommendations for chronic HCV infection treatment. An agreement between experts was reached regarding the therapy of the special categories of patients infected with HCV, complications and monitoring of the therapy, follow-up of the patients who reached sustained virologic response and re-treatment of the patients with therapy failure.Conclusions: This Position Paper represents a guide for the assessment and the therapy of HCV infection. The recommendations are in concordance with other guidelines but are applied to real-life conditions in Romania. Abbreviations: CKD: Chronic kidney disease; DAAs: Direct-acting antivirals; DDIs: Drug-drug interactions; ESDL: End-stage liver disease; FCH: Fibrosing cholestatic hepatitis; GT: Genotype; HCV: Hepatitis C virus; HCC: Hepatocellular carcinoma; LT: Liver transplantation; MELD score: Mayo-Clinic End-Stage Liver Disease score; PDC: Premature discontinuation; PWID: Persons who inject drugs; RASs: Resistance associated substitutions; RBV: Ribavirin; RCT: Randomized controlled trial; SAE: Serious adverse events; SRGH: Romanian Society of Gastroenterology and Hepatology; SVR: Sustained virologic response.