Effectiveness and safety of newly introduced endoscopic submucosal dissection in a Western center: a real-life study.

OBJECTIVES: Endoscopic submucosal dissection (ESD) is a minimally invasive technique for the resection of superficial gastrointestinal lesions, providing high rates of 'en bloc' and R0 resection. East-West differences in ESD quality indicators have been reported. This study aims to assess feasibility, effectiveness, and safety of ESD for the treatment of superficial gastrointestinal (GI) lesions in a Western cohort. METHODS: Consecutive patients undergoing ESD at one Italian endoscopic referral center from September 2018 to March 2020 were included in this prospective study. Primary outcomes were technical success, R0 resection rate, curative resection rate, and adverse events (AEs). RESULTS: In total 111 patients (111 lesions) undergoing ESD were included. Anatomic site of the lesions was rectum in 56.8%, colon in 13.5%, stomach in 24.3%, and esophagus in 5.4% of cases, respectively. For upper GI procedures, technical success was 100%, and R0 and curative resection rates were 84.8% and 78.8%, respectively. For colorectal procedures, technical success was 98.7%, R0 and curative resection rates were 88.5% and 84.6%, respectively. Major AEs were reported in 12 cases (10.8%). CONCLUSION: The introduction of ESD in a Tertiary Center is feasible, effective, and safe, and should be taken into consideration for the treatment of superficial GI lesions requiring 'en bloc' resection.

Enhanced liver fibrosis score as a noninvasive biomarker in hepatitis C virus patients after direct-acting antiviral agents.

Background: In more than 90% of chronic viral hepatitis C (HCV) patients treated with direct-acting antiviral agents (DAAs), a sustained viral response (SVR) was observed. Unfortunately, there are subgroups of subjects who display enduring liver fibrosis and are at high risk of developing hepatocellular carcinoma (HCC). Thus, liver fibrosis evaluation during the follow-up of these patients plays a pivotal role. The gold standard to evaluate hepatic fibrosis is liver biopsy, which is an invasive procedure. Imaging techniques and serum biomarkers have been proposed as safer and cheaper procedures. Objectives: In this study, we evaluated the concordance of transient elastography (TE) with ELF score ( enhanced liver fibrosis) in a cohort of patients with HCV before and after direct-acting antiviral (DAAs) treatment. ELF score has been validated in other chronic liver diseases; the evidence is not available in HCV patients treated with DAAs. Study design: We prospectively recruited all consecutive HCV patient candidates for DAAs therapy at the University of Naples "Federico II" between April 2015 and July 2016. TE and ELF scores were assessed at baseline, at SVR24, and at SVR48. Results: One-hundred-nineteen patients were treated with DAAs, and 94.1% of them reached SVR. A total of 55.5% of patients were males with a mean age of 64.7 ± 9.6 years. TE results revealed that 12 patients (10%) had F1-2 mild/moderate fibrosis, and 107 (90%) had F3-4 advanced fibrosis. At baseline, SVR24, and SVR48, the concordance between ELF test and TE was poor: 0.11 (p = 0.086), 0.15 (p = 0.124), and 0.034 (p = 0.002), respectively. However, at SVR24 and SVR48, both methods showed a significant amelioration of liver fibrosis compared to baseline (p < 0.001). In addition, both ELF index and TE were significantly associated with portal hypertension at baseline, but not with varices and ascites. Conclusions: Our findings suggested that ELF test could predict changes in liver fibrosis, independently of TE. In case of TE unavailability, ELF score could represent an appropriate tool. Notably, in the context of the COVID-19 pandemic, ELF testing should be encouraged to reduce unnecessary access to the hospital and prolonged physical contact.

COVID-19 in liver transplant recipients: incidence, hospitalization and outcome in an Italian prospective double-centre study.

Liver transplant (LT) recipients are vulnerable to SARS-CoV-2-infection (COVID-19), due to immunosuppression and comorbidities. This study aimed to evaluate the impact of COVID-19 on LT recipients compared to general population in the Campania region. In this prospective double-centre study, we enrolled all consecutive adult LT recipients with confirmed SARS-CoV-2-infection. Data were collected at diagnosis of COVID-19 and during follow-up and compared with the regional population. Thirty LT recipients (3.28%) developed SARS-CoV-2-infection (76.66% male, median age 62.61 years). Sixteen (53.33%) were symptomatic. Common symptoms were fever, cough, fatigue, and anosmia. Twenty-five (83.33%) were outpatients, 5 (16.66%) required hospitalization (6.66% admitted to Intensive Care Unit, 6.62% developed Acute Respiratory Distress Syndrome and 6.66% died). Immunosuppressors were in 3 (10%) patients. Incidence rate of COVID-19 was similar between LT patients and general population (3.28% vs 4.37%, p = 0.142) with higher rate of symptoms in LT patients (53.33% vs 15.87%, p < 0.000). At univariate analysis, hospitalization and case fatality rates were higher in LT patients compared to general population (16.66% vs 4.54%, p = 0.001; and 6.66% vs 1.76%, p = 0.041, respectively). At multivariable logistic regression analysis, LT patients with COVID-19 were more frequently symptomatic (OR 5.447 [95% CI 2.437-12.177], p < 0.000), whereas hospitalization and death for COVID-19 were not significatively associated with LT condition (p = 0.724 and p = 0.462, respectively) and were comparable with general population. LT is not a risk factor for acquiring COVID-19. Nonetheless, LT patients are more frequently symptomatic, although comparable to the general population for hospitalization rate and mortality.

Metabolic-associated fatty liver disease (MAFLD) in coeliac disease.

BACKGROUND AND AIMS: Coeliac disease (CD) is considered a high-risk condition for developing non-alcoholic fatty liver disease (NAFLD) and other related metabolic disorders, particularly after commencing gluten-free diet (GFD). Recently, a new concept of metabolic-associated fatty liver disease (MAFLD) has been proposed to overcome the limitations of NAFLD definition. This study aimed at exploring the prevalence of NAFLD and MAFLD in CD patients at the time of CD diagnosis and after 2 years of GFD. Furthermore, we evaluated the role of PNPLA3 rs738409 in the development of NAFLD and MAFLD in the same population. METHODS: We retrospectively enrolled all newly diagnosed CD patients who underwent clinical, laboratory and ultrasonography investigations both at diagnosis and after 2 years of follow-up. Moreover, a PNPLA3 rs738409 genotyping assay was performed. RESULTS: Of 221 newly diagnosed CD patients, 65 (29.4%) presented NAFLD at CD diagnosis, while 32 (14.5%) met the criteria for MAFLD (k = 0.57). There were no significant differences between NAFLD and MAFLD, except for the higher rate of insulin resistance (IR) of MAFLD patients (75% vs 33.8%, P < .001). At 2 years of follow-up, 46.6% of patients developed NAFLD while 32.6% had MAFLD (k = 0.71). MAFLD subjects had higher transaminases (P = .03), LDL-cholesterol (P = .04), BMI and waist circumference and higher IR than NAFLD patients. MAFLD patients showed higher non-invasive liver fibrosis scores than NAFLD subjects (APRI = 1.43 ± 0.56 vs 0.91 ± 0.62, P < .001; NFS=-1.72 ± 1.31 vs -2.18 ± 1.41, P = .03; FIB-4 = 1.27 ± 0.77 vs 1.04 ± 0.74, P = .04). About PNPLA3 polymorphisms, at 2 years follow-up, NAFLD subjects presented a higher rate of heterozygosis (40.8%) and homozygosis (18.4%) polymorphisms than non-NAFLD (26.3% and 7.6%, respectively, P = .03 and 0.02), while no correlation between PNPLA3 polymorphisms and MAFLD was seen. CONCLUSIONS: The new MAFLD definition better reflects the metabolic alterations following GFD in CD population. This new classification could be able to identify patients at higher risk of worse metabolic outcome, who need a close multidisciplinary approach for their multisystemic disease.

Use of Telemedicine for Chronic Liver Disease at a Single Care Center During the COVID-19 Pandemic: Prospective Observational Study.

BACKGROUND: The COVID-19 outbreak has overwhelmed and altered health care systems worldwide, with a substantial impact on patients with chronic diseases. The response strategy has involved implementing measures like social distancing, and care delivery modalities like telemedicine have been promoted to reduce the risk of transmission. OBJECTIVE: The aim of this study was to analyze the benefits of using telemedicine services for patients with chronic liver disease (CLD) at a tertiary care center in Italy during the COVID-19-mandated lockdown. METHODS: From March 9 to May 3, 2020, a prospective observational study was conducted in the Liver Unit of the University Hospital of Naples Federico II to evaluate the impact of (1) a fully implemented telemedicine program, partially restructured in response to COVID-19 to include video consultations; (2) extended hours of operation for helpline services; and (3) smart-working from home to facilitate follow-up visits for patients with CLD while adhering to social distancing regulations. RESULTS: During the lockdown in Italy, almost 400 visits were conducted using telemedicine; only patients requiring urgent care were admitted to a non-COVID-19 ward of our hospital. Telemedicine services were implemented not only for follow-up visits but also to screen patients prior to hospital admission and to provide urgent evaluations during complications. Of the nearly 1700 patients with CLD who attended a follow-up visit at our Liver Unit, none contracted COVID-19, and there was no need to alter treatment schedules. CONCLUSIONS: Telemedicine was a useful tool for following up patients with CLD and for reducing the impact of the COVID-19 pandemic. This system of health care delivery was appreciated by patients since it gave them the opportunity to be in contact with physicians while respecting social distancing rules.

Liver stiffness assessment by transient elastography suggests high prevalence of liver involvement in common variable immunodeficiency.

BACKGROUND: Up to 50% of patients with common variable immunodeficiency (CVID) present persistently increased serum levels of liver enzymes and/or mild hepatomegaly. Ultrasound-based transient elastography (TE) is largely used for early detection of the progression of chronic liver diseases, but has never been employed in CVID. We performed a cross-sectional study to evaluate TE values in a cohort of adult CVID-patients. METHODS: Full blood count, liver function test, liver and spleen sonogram and ultrasound-based TE were performed in 77 adult CVID patients. Demographic and clinical data were retrospectively collected from medical files. RESULTS: 33.8% (26/77) patients presented increased TE values ranging from moderate fibrosis to cirrhosis. TE values were positively correlated with ALP, γGT, spleen longitudinal diameter and peripheral blood counts (no significant correlation with BMI, AST, ALT, total proteins, albumin, bilirubin and hemoglobin). Moreover, liver stiffness was higher in patients with the clinical phenotypes polyclonal lymphoproliferation and enteropathy, and patients with both these complications had an increased risk (OR: 7.14) of presenting pathologic TE values compared with those without anyone of these. CONCLUSIONS: Transient elastography is a useful tool to be used alongside clinical and laboratory data to assess liver involvement in CVID.

Berberis aristata, Elaeis guineensis and Coffea canephora Extracts Modulate the Insulin Receptor Expression and Improve Hepatic Steatosis in NAFLD Patients: A Pilot Clinical Trial.

Non-alcoholic fatty liver disease (NAFLD) is associated with insulin resistance and diabetes. A reduction in insulin receptor (IR) expression has been reported in these patients. The aims of this study were to evaluate the effects of a mixture of plant extracts consisting of Berberis aristata, Elaeis guineensis and decaffeinated green coffee by Coffea canephora on the improvement of glycaemic profile, through the modulation of IR levels, and of hepatic steatosis in NAFLD patients. Forty-nine patients with a grade of steatosis S1-S2 were randomly allocated to the treatment with plant extracts or placebo for six months. Hepatic steatosis was evaluated using transient elastography with CAP (controlled attenuation parameter). Glucose, insulin, and IR levels were measured in serum samples. At the end of the study, patients treated with plant extracts displayed a significant reduction of serum glucose (p < 0.001), insulin levels (p < 0.01), homeostatic model assessment for insulin resistance (HOMA-IR) index (p < 0.001), and CAP value (p < 0.01) compared to placebo. Moreover, the IR expression was increased significantly in the plant extracts group compared to the placebo group (p < 0.05). The combination of plant extracts increases serum IR levels, determining amelioration of glycemic profile and improvement of hepatic steatosis in NAFLD patients.