Active clinical trials for "Liver Cirrhosis"

Hepatocellular carcinoma (HCC) is a frequent complication of cirrhosis. Occurrence of HCC could be linked with multiple functional region of genome. The determining of a genomic mapping of " single nucleotide polymorphisms " (SNPs) permit to perform some genetic link studies with pathologies without clear hereditary disposition. In this study, the investigators will identify predictives genetic polymorphism of HCC.

The elimination of the carbohydrate galactose is used in daily clinical work with liver patients as a quantitative measure of metabolic liver function, as the liver test "The Galactose Elimination Capacity", GEC. We are working to develop a PET/CT scanning procedure for providing 3D images of the hepatic galactose elimination and measurement of regional values. This may be used for example for planning resection or stereotactic radiotherapy of a patient with malignant tumor in the liver. Will the patient be able to tolerate removal of the necessary part of the liver? We will include 10 patients with liver cirrhosis and 6 healthy human subjects. Direct measurements of the hepatic galactose elimination (successive constant iv infusions of galactose in increasing doses with measurements of blood concentrations of galactose in blood from an artery and a liver vein, and measurements of liver blood flow by indocyanine green, Ficks principle) are compared with PET/CT measurements after iv injection of a 18F-labelled galactose analog, FDGal. Based on previous studies in pigs, we perform detailed calculations of the hepatic galactose elimination kinetics by the two methods, including estimation of a factor ("lumped constant") for recalculating PET/CT data to data for natural galactose. Besides possible practical clinical importance, the project elucidates basic problems concerning liver metabolism using PET.

The purpose of this study is to describe the HRQoL in those with MELD scores </= 15 in a single center for those who are pre-liver transplant candidates

Patients with cirrhosis have a altered cardiac response to stress. This study evaluate the cardiac response by MRI during dobutamine stress. Hypothesis: impared increase in cardiac output, cardiac index, ejection fraction.

Indocyangreen (ICG)is totally biliary eliminated and corresponds to hepatocyte function and liver perfusion. The ICG-clearance will be evaluated as a prognostic marker in liver disease.

Methotrexate is one of the commonly used conventional systemic treatment for moderate to severe psoriasis as well as psoriatic arthritis. It is also used as co-therapy with TNF-antagonists to improve efficacy and reduce neutralizing drug antibodies formation. Apart from the bone marrow suppression, which can largely be avoided with careful dosing, monitoring and avoidance of certain drug interaction, hepatotoxicity is one of the major side-effects. The prevalence of significant liver fibrosis in patients taking methotrexate is estimated to be 5% and cirrhosis 1-2%. The British Association of Dermatologist's guideline (2016) discussed a few non-invasive tests such as the amino-terminal peptide of procollagen III (PIIINP), Fibrotest and transient elastography. While PIIINP was recommended to be used in baseline and serial assessment, liver stiffness measurement by transient elastography is not yet widely used owing to lack of high-quality data. Transient elastography (TE) has been shown to correlate well with liver fibrosis and has been widely adopted as a non-invasive method to assess liver fibrosis in various chronic liver disease. Two-dimensional shear wave elastrography (2D SWE) is a novel ultrasound technique that combines shear wave elastography with traditional ultrasound imaging. Liver stiffness measurement can be performed under the guidance of high rate B-mode image, allowing real-time visualization of liver parenchyma and avoidance of non-target structures such as vessels or focal liver lesions. In view of the demand of a safer and reliable non-invasive test to detect advanced liver fibrosis in psoriasis patients receiving methotrexate, we propose to recruit at-risk patients for a paired TE and 2D SWE assessment and liver biopsy.

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.

Liver transplantation is an effective treatment for end-stage liver disease. Cardiovascular complications are the common causes of death in liver transplant recipients. The presence of cirrhosis cardiomyopathy has a potential impact on the prognosis of liver transplant recipients. Therefore, it is important to identify the high risk factors with cirrhotic cardiomyopathy before transplantation, so as to intervene earlier and improve the prognosis of patients.

"Mortality related to complications of cirrhosis, (hemorrhage, hepatic insufficiency and primary liver cancer) is 15,000 per year in France. These mortality increases, despite that advanced fibrosis can be identified by non-invasive biomarkers and treated, more than 10 years before the onset of complications and cancer. The main goals of the FIBROFRANCE project which started in 1997 (initially called the MULTIVIRC group) were to demonstrate the performance of serum biomarkers in the more frequent chronic liver diseases, to estimate the dynamic of fibrosis progression and finally to demonstrate the feasibility of the fibrosis screening in French people. The different cohorts of the FIBROFRANCE (HCV, HBV, ALD, NAFLD) permitted many publications among the 186 publications of our group since 1986 in the field of liver fibrosis. These publications included discovery and validation of non-invasive biomarkers (Poynard Gastroenterology 1997, Imbert-Bismut Lancet 2001, Poynard BMC Gastro 2007), modelling fibrosis progression or regression (Poynard Lancet 1997, Poynard Gastroenterology 2002, Poynard J Hepatol 2003) and fibrosis screening (Ratziu APT 2007, Jacqueminet Clin Gastrenterol Hepatol 2008). This research was conducted in Pitié-Salpêtrière hospital for the biochemical and clinical part in connection with national and international networks. Several panels have been identified and the most predictive FibroTest has been patented (US Patent Office 6.631.330) and launched in 2002. This is the first fibrosis biomarker available worldwide (50 countries including USA as FibroSURE) with more than 1 million prescriptions between 2002-2013. FibroTest, has been validated first in hepatitis C and then in hepatitis B alcoholic liver disease and metabolic syndrome. Therefore it is now possible to screen advanced fibrosis in the 4 most frequent liver diseases: alcohol, hepatitis C and B, and metabolic syndrome (diabetes, overweight, and hyperlipemia). For all the patients detected there are therapeutic options to cure the fibrosis or to reduce the progression to cirrhosis and cancer. FibroTest has been recommended as alternative to biopsy in several guidelines (AFEF, APASL, EASL and CASLD) and more recently in US overview (Chou Annals 2013). It reimbursed in France in chronic hepatitis C. Several factors of fibrosis progression can be present in the same subject, i.e. an overweight and an excessive alcohol consumption. Therefore no realistic screenng strategy can be conducted without taking into account the Interdependence of the different risk factors. Three biomarkers of fibrosis-associated liver injuries have been developed and validated in FIBROFRANCE cohorts: SteatoTest for steatosis (Poynard Comp Hepatol 2005), NashTest for non-alcoholic steatohepatitis (Poynard EASL 2006), and AshTest for alcoholic steatohepatitis (Naveau J Hepatol 2006). For this purpose different cohorts already used for diagnostic validation will be followed at long term for prognostic validations: FIBROFRANCE-ALD (Naveau Hepatology 2010), FIBROFRANCE-NAFLD including dyslipidemia cohort (Ratziu APT 2007) and diabetes cohort (Jacqueminet Clin Gastrenterol Hepatol 2008). These cohorts will allow assessing the prevalence of fibrosis and the specific risks of fibrosis progression imputable to steatosis and steatohepatitis.

Newly development of capsule endoscopy provides a comfortable and minimal invasive modality which is an alternative to conventional esophagogastroduodenoscopy(EGD). The use of capsule endoscopy beyond the small bowel is increasing and several capsule endoscopy systems have been introduced for the examination of the esophagus and colon. The current capsule endoscopy systems are less effective for the upper gastrointestinal tract examination. Short transit time in the esophagus and the passive movement of the capsule makes it more difficult to identify or visualize the lesion comparing with traditional EGD. The sensitivity rate of esophageal varices detection from capsule endoscopy was ranging from 65% to 80%. In order to control the capsule in the gastrointestinal tract for better visualization, many methods are invented. Magnetically assisted capsule endoscopy systems and string-mounted capsule endoscopy are applied in many studies. Magnetically assisted capsule endoscopy system and string-mounted capsule endoscopy are used to control the capsule endoscopy for elongating esophagus transit time to have a better visualization of the esophagus. The InsightEyes EGD System combines the string and magnetic assisted capsule endoscopy system to provide a real-time high-quality image during the examination. On the other hand, 3D image processing can be used for distinguishing the esophageal varices and normal folds well, theoretically. Thus, in this study, the investigators combine string, magnetically assisted capsule endoscopy systems, and 3D image processing together to form a new system for improving the detection of esophageal varices and other gastric lesions.