Vitamin B-6 and Glutathione on Inflammation, Homocysteine, Oxidative Stress and Antioxidant Capacities...
Liver CirrhosisLiver CancerThis study is designed as a hospital-based cross-sectional and randomized placebo-controlled intervention trial. One hundred and fifty patients with either cirrhosis or cirrhosis combined with hepatocellular carcinoma (HCC) who meet the inclusion criteria will be recruited from Taichung General Veterans Hospital. One hundred patients will be randomly assigned to either the 1) placebo group (n = 25); 2) vitamin B-6 group; (50 mg/d, n = 25); 3) glutathione (GSH) group (500 mg/d, n = 25); or 4) vitamin B-6 (50 mg/d) plus GSH (500 mg/d) group (n = 25) for 3 mo. Data on demography, anthropometry and medical history will be collected. Patients with cirrhosis or cirrhosis combined with HCC will have fasting blood drawn in the clinics. Additionally, patients who participated in the intervention study will have blood drawn at month 0, 1, 2 and 3 during intervention period. Hematological measurements, plasma vitamin B-6 status, GSH, inflammatory markers, homocysteine, cysteine, SAM, SAH, oxidative stress indicator, oxidized GSH and GSH related antioxidant enzyme activities will be analyzed.
Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia
Liver CirrhosisHyponatremiaThis is a phase IV, open-label, prospective cohort study for 7 days.The recommended starting dose of tolvaptan is 15 mg daily orally. The dose may be titrated on the next day at 15 mg intervals up to 60 mg daily according to the serum sodium level response.Serum sodium level, change in sodium level from baseline, quality of life (EQ-5D-3L), change in body weight, edema, renal function, mortality and liver-related complications on day 7 and day 30 to evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia.
A2ALL-Patients Safety System Improvements in Living Donor Liver Transplantation
Liver DiseasesHepatocellular Cancer2 moreLiving donor liver transplantation (LDLT), involves complex systems and processes of care that are particularly vulnerable to medical errors and preventable complications. This ancillary study of the Adult-to-Adult Living Liver Transplantation Cohort Study (A2ALL) will focus on conducting a proactive, systematic, and comprehensive assessment of the vulnerabilities in the systems and process of LDLT care to reduce medical errors and preventable complications thereby improving the safety of LDLT care. This project will address an important gap in the knowledge needed to achieve high quality and safe LDLT care of patients by developing a process to: 1) proactively, systematically and comprehensively identify areas of vulnerabilities in LDLT care that can result in medical errors, 2) design and implement solutions to mitigate these weaknesses, and 3) evaluate the effectiveness of these solutions to improve the safety of LDLT care by measuring clinical and process outcomes before and after solution implementation across four A2ALL participating transplant centers
Rifaximin Predicts the Complications of Decompensated Cirrhosis
CirrhosisCirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and increased intestinal permeability all leading to an increase in bacterial translocation and increased endotoxemia. Rifaximin is an antibiotic that is virtually non-absorbed after oral administration and exhibits broad spectrum antimicrobial activity against both aerobic and anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract. It has been suggested that oral prophylactic antibiotics or bowel decontamination might improve long-term outcomes in patients with cirrhosis. The aim of this study was to explore the suitable dose of rifaximin to alleviate endotoxemia and prevent the complications of advanced cirrhosis.
Portal Vein Thrombosis Relevance on Liver Cirrhosis: Italian Venous Thrombotic Events Registry
Liver CirrhosisPortal Vein ThrombosisThe portal vein thrombosis (PVT) can complicate medical conditions like liver cirrhosis (LC), neoplasms, myeloproliferative diseases, thrombophilic genotypes, infections, inflammatory diseases, trauma and surgery. LC is an important predisposing disease and is responsible for about 20% of all cases. However, data regarding the PVT in cirrhosis are insufficient. Early studies have shown that, in absence of hepatocellular carcinoma (HCC), the PVT can occur in approximately 10% of cirrhotic patients. Most of studies are in support of a prevalence between 5 and 20% of patients with LC. A study in transplant recipients, has documented that in variable etiology cirrhosis, the PVT was present in 15.7% of patients, a higher percentage was found in patients with liver cancer (34.8%), while primary biliary cirrhosis (7.9%) and sclerosing cholangitis (3.6%) are less frequently complicated by PVT. The PVT development is due to stagnation in the portal circulation, but alterations in the sense of inherited or acquired pro-coagulant may favor its appearance. The causal association of PVT with bleeding and bowel infarction suggests that the PVT may reduce survival in cirrhosis, but data are lacking on this issue. It is also not known whether asymptomatic patients with PVT have a different survival compared to cirrhotic patients without PVT. Further studies should be conducted to clarify this issue. Likewise, prospective studies are needed to better identify risk factors predisposing to PVT in LC patients as well as to clarify the relationship between cirrhosis severity and PVT. The impact of PVT on the natural history of cirrhosis is an issue today still debated. The PVT not only favour life-threatening complications (gastrointestinal bleeding and mesenteric thrombosis) but could also contribute to a deterioration of liver function by reducing portal flow. Obtaining such information would be of crucial importance considering that the evidence of increased mortality related to PVT in liver cirrhosis may indicate the need for randomized controlled trials to clarify the potential effectiveness of anticoagulant therapy to improve the survival. To this purpose it's proposed to establish an Italian register of patients with cirrhosis. In the second phase of the project is planned a 2-years follow-up program in order to assess whether the PVT be an additional risk factor for mortality or deterioration of the natural history in patients with cirrhosis.
An Observational Study of Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) on Predictive...
Hepatitis CChronicThis observational study will evaluate the predictive value of rapid virological response (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will be followed for 48 weeks of treatment and up to 24 weeks of follow-up.
Improved Prevention of Perinatal Hepatitis B Transmission
Liver FibrosisImpaired activity of Natural Killer (NK) cells has been proposed as a mechanism contributing to viral persistence in Hepatitis C Virus (HCV) infection. NK cells display anti-fibrotic activities by killing activated hepatic stellate cells (HSCs) that have lost the self-recognition marker; Major Histocompatibility (MHC) class I. Determining the down-expressed genes on NK cells necessary for their anti-fibrotic activity was never studied previously. This will allow us to study their role fully in phagocytosis process as well as their interaction of HSCs and therefore manipulating these genes using molecular techniques. Exploring the cellular functions of these genes will highlight their involvement in the progression of liver fibrosis and could be used as a therapeutic tool for preventing the disease.
Indocyanine Green and Portal Pressure in Viral and Alcoholic Cirrhotic Patients With Hepatocarcinoma...
CarcinomaHepatocellular3 moreThe aim of the investigators' study is to elucidate the relationship between a functional liver test (e.g., ICG) and the PREOPERATIVE value of portal hypertension in the patients with impaired liver function from alcoholic and non-alcoholic aetiologies. Alcoholic and viral cirrhosis present important differences in terms of cellular mechanisms responsible for the disease progression with a distinct and unique gene expression pattern that regulates the type of inflammatory response. These differences probably influence the hepatic functional reserve and the onset of portal hypertension at a comparable clinical and biological level of derangement and the investigators may expect significant differences in the recovery from hepatectomy. The investigators' hypothesis is that at a comparable ICGR-15 rate non-viral cirrhotic liver presents higher portal pressure values and the investigators also argue that alcoholic cirrhotic patients would tolerate a larger hepatic resection than would viral cirrhotic do.
Gastric Variceal Ligation Versus Gastric Variceal Obturation for Secondary Prophylaxis of Gastric...
Gastroesophageal VaricesLiver CirrhosisThe investigators establish a randomized controlled clinical trial, comparing the efficacy and prognosis of GVL and GVO in secondary prevention of GVs, especially in patients with portosystemic shunting, and exploring the endoscopic treatment selection of different types of GVs. Outcome expectations: Compared with glue injection, endoscopic ligation for secondary prevention of gastric varices is safe and effective, especially in patients with portosystemic shunting.
Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics
Liver CirrhosisThe study will be conducted in department of Hepatology at ILBS, the patients will be recruited from the OPD or IPD . The obese cirrhotic patients with NASH will be observed for standard of care and also patients who undergo IGB placement as part of weight reduction policy in these group of patients and will undergo an UGI endoscopy followed by placement of intragastric balloon. Then the patients will be admitted for 2-3 days and followed up till 6 months.