View clinical trials related to Liver Cirrhosis.
Filter by:Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment naive patients with HBV related liver fibrosis.
Cirrhosis of liver is a leading cause of morbidity and mortality worldwide. Complications like ascites, spontaneous bacterial peritonitis, variceal bleed, hepatic encephalopathy, hepatorenal syndrome (HRS) and hepatocellular carcinoma (HCC) portend a poor prognosis and further decreases survival in these patients. The major causes of cirrhosis include excessive alcohol consumption, viral hepatitis and non- alcoholic fatty liver disease. Currently the only definitive treatment option for cirrhosis is liver transplantation which is limited in its applicability due to donor shortage, exorbitant costs and lack of widespread availability. Moreover, it requires lifelong immunosuppression and has considerable long term side effects including chronic renal failure, post-transplant lymphoproliferative disease and cardiovascular complications. The ability of stem cells to differentiate into multiple cellular lineages makes one speculate that stem cells can be used for tissue repair and regeneration when tissue-resident stem cells become overwhelmed. It has been shown that in response to acute or chronic liver damage, bone marrow derived stem cells can spontaneously populate the liver and differentiate into hepatic cells, thereby contributing to hepatic regeneration. Thus, apart from hepatocytes and intrahepatic stem cells, bone marrow derived stem cells also participate in the liver regeneration process. Currently, there are two methods to mobilize stem cells from the bone marrow to the liver. One is administration of cytokines like granulocyte-colony stimulating factor (G-CSF) and the other is the isolation of stem cells from the marrow and their injection into the hepatic artery or portal vein after purification. The latter is probably more cumbersome and may be potentially risky due to the underlying coagulation abnormalities in cirrhotic patients. Improved liver histology and survival has been noted in patients with cirrhosis following mobilization of bone marrow stem cells by granulocyte-colony stimulating factor (G-CSF). Three recent studies have demonstrated G-CSF induced mobilization of bone marrow stem cells (CD34 cells) in peripheral blood and their subsequent increase in liver tissue and improved survival in patients with alcoholic hepatitis and ACLF. However, there is a paucity of data on whether G-CSF improves survival and prognosis in patients with decompensated cirrhosis. Verma, Singh et al have shown in an open label trial that there was significantly better 12 month transplant free survival in ( GCSF+ Growth hormone + standard medical therapy group ) and ( G CSF + standard medical therapy group ) as compared to standard medical therapy group alone. CD 34+ cells at day 6 of therapy increased as compared to baseline. There was also a significant decrease of clinical scores, improvement in nutrition, better control of ascites, reduction in liver stiffness, lesser episodes of infection as well as improvement in QOL scores in the treatment groups having G CSF as compared to baseline. In a recent study by Newsome et al, a multicentre, open label randomized phase 2 trial, patients were randomized to standard care, treatment with subcutaneous G CSF or treatment with G CSF for 5 days followed by leukaphersis and IV infusion of CD 133 positive haematopoietic stem cells. They did not find any difference in MELD score over time in all 3 treatment groups. Serious adverse effects were more common in the G CSF groups than in standard treatment group. In a study by Kedarisetty CK et al. a significantly larger proportion of patients with decompensated cirrhosis given a combination of G-CSF & Darbopoietin α survived for 12 months more than patients given only placebo ( 68% vs. 26.9%; P = 0.001 ). The combination therapy also reduced liver severity scores and sepsis to a greater extent than placebo. In view of the conflicting results of the above studies and no studies on the use of multiple courses of GCSF in patients with decompensated cirrhosis in a double blind manner, the present study was undertaken to assess the safety and efficacy of G-CSF in patients with decompensated cirrhosis in the form of a double blinded RCT.
Cirrhotic patients are at higher risk of sepsis due to impaired innate and adaptive immune responses. Septic complications represent a major issue in the management of cirrhotic patients, with a 1-month mortality rate of 23%, which increases to 80% at 3 months in case of associated organ failure. Delay to treatment initiation during a septic episode may increase the risk of complications and mortality of cirrhotic patients. However, the inappropriate use of antibiotics exposes cirrhotic patients to the risk of more severe infections due to multi-resistant organisms or fungi. The use of diagnostic markers for sepsis is limited in the context of cirrhosis because of the lack of hepatic synthesis of these markers on the one hand and non-specific inflammation related to cirrhosis on the other hand. Therefore, it is necessary to develop new tools for the early diagnosis of sepsis and appropriate management of cirrhotic patients. The interest of microRNAs (miRNAs) in the diagnosis and prognosis of septic shock has been reported in the general population. No studies have described circulating miRNAs or reported their interest in the diagnosis of sepsis in a population of cirrhotic patients with acute decompensation (AD). This preliminary study of 800 circulating miRNAs will be performed in a cohort of patients with acute cirrhosis decompensation, for whom the incidence of sepsis is estimated at 40%. The aim to evaluate the interest and feasibility of a larger study on the interest of circulating miRNAs in the early diagnosis of sepsis in cirrhotic patients. The long-term objective of this study is the development of biomarkers for the early management of cirrhotic patients with sepsis and the rationalization of antibiotic use to improve their prognosis.
Sarcopenia is an independent predictor of morbidity and mortality in the cirrhotic patient. Beta-hydroxy-beta-methyl butyrate (HMB) is a leucine metabolite with potential efficacy in increasing protein synthesis, muscle mass, and its functionality. The aim of this randomized controlled study is to evaluate the effect of nutritional supplementation with HMB and physical activity both on muscle mass and on muscle function in cirrhotic patients.
In a retrospective study, 200 patients with non-alcoholic fatty liver disease, fatty liver hepatitis, and fatty liver fibrosis have been identified for pathological diagnosis of liver histology and exclusion of other liver diseases. Before the liver biopsy were performed, these patients should detect liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity measurement and imaging indicators and results, and demographic data. To evaluate the diagnostic ability of the current non-invasive diagnostic model of NAFLD fibrosis and the adaptability of model indicators to the diagnosis of enrolled patients, and to correct the indicators, including discarding unsuitable indicators and incorporating new indicators, and adjusting the diagnostic score. Establish a non-invasive diagnostic model for liver fibrosis in Beijing based on NAFLD. In a prospective observational study, 100 patients without other liver diseases and ultrasound-tested fatty liver were enrolled, and histopathological diagnosis of liver were included in the study, and liver function, coagulation function, renal function, blood glucose, and non-invasive model analysis were detected. Blood lipids, liver elasticity measurements, and imaging indicators were examined and demographic data were collected. The non-invasive diagnostic model established by retrospective study was used to diagnose fibrosis and its staging, compared with histopathological diagnosis, and adjusted the index of non-invasive diagnostic model to further revise and improve the diagnostic efficacy of the diagnostic model. Long-term follow-up observations were performed in the prospective observation cohort. The liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity and imaging examination were performed during the observation period, and the treatment events and the progress of the patients were recorded. To explore the correlation and predictive ability of noninvasive diagnostic models for long-term outcomes of disease. Finally, a model for predicting the outcome of progression of liver fibrosis in NAFLD was established.
This study is to evaluate the safety and efficacy of a single dose of Cellgramâ„¢ delivered via hepatic artery in patients with decompensated alcoholic liver cirrhosis.
All consenting, adult patients aged 18 years and above who will require elective ventilation after liver transplant recipient surgery will be enrolled for the study. Patients in acute liver failure, hepatic encephalopathy or patients with history of allergic reactions to propofol will be excluded from the study. This is an observational study. As per institute treatment protocol, propofol will be given post-operatively at a dose of 1 mg/kg/hr and than titrated to maintain a Bi-Spectral Index (BIS) score of 60-80 till the patient is on ventilator. There will be no deviation from our routine institutional protocol and no other sedative drugs like opioids or benzodiazepines will be used and no interventions will be done. Hemodynamics will be maintained targeting a mean arterial pressure (MAP) of at least 65 mm Hg. during the study period using appropriate measures.
Liver Diseases in pregnancy represents rare disorders and current data is derived primarily from single centres and retrospective cohorts. Moreover, the population prevalence of these diseases is low and to-date, it has proven difficult to generate reliable data at a patient level. This is a multi-center, prospective cohort study that will open at 3 centers within the UK; and 4 centers in the European Union. The investigators will aim to collect data and blood samples at various time points, for patients presenting with liver disease during pregnancy. The main rationale behind this study is to establish a platform that enables detailed review of the outcomes of these rare diseases; to help classify and stratify patients according to risk and develop interventional studies and care pathways to improve overall outcome.
A total of 50 patients will be enrolled and will be randomized into either Group A(TIPS) or Group B (SEMS). Primary end point of the study will be to compare efficacy of TIPS versus SEMS for survival at 6 week or Early re Bleed. All enrolled patients will also undergo HVPG measurement at baseline to stratify risk of failure to control bleed or early re-bleed. Patient will be monitored for 5 days for re bleed, complications of therapy, worsening of Liver function tests and scores and efficacy of either treatment modality over other. Patient will be followed for 6 weeks to see for the primary end point.
A total of 80 adult chronic hepatitis B patients with advanced liver fibrosis (including fibrosis stage 3 and cirrhosis), who are currently on nucleot(s)ide analogs (except tenofovir alafenamide) therapy with detectable HBV DNA after 52 weeks of therapy will switch prior NUCs to TAF 25 mg/day for 96 weeks