Active clinical trials for "Liver Cirrhosis"

Primary Objective: To evaluate the long-term outcomes including liver related morbidity, mortality and hepatocellular carcinoma (HCC) development as compared to those of historical control with interferon(IFN)-based treatment. Secondary Objective: To access liver fibrosis progression/regression in CHC patients after sofosbuvir-based treatment. To investigate the long-term outcomes of extrahepatic manifestations of the sofosbuvir-based treated cohort as compared to their pretreatment status.

The study aims to evaluate the feasibility of transnasal endoscopy in patients with portal hypertension, cirrhotic and non-cirrhotic. The incidence of the procedure's adverse effects, the patient's tolerance and his/her opinion about the exam are analyzed. In addition, the interobserver matched for the discoveries found in the study is carried out.

Acute kidney injury (AKI) is a common complication, occurring in approximately 20% of hospitalized cirrhotic patients and has a significant negative impact on patients' outcomes according to either the initial stage (at the time of the first fulfillment of AKI criteria), or the peak stage (at the peak value of serum creatinine concentration during hospitalization). Among all the precipitating factors to cirrhotic AKI, acute gastrointestinal hemorrhage is a common cause that leads to a decrease in effective arterial blood volume in the hyperdynamic circulatory status of cirrhosis. However, there is still lack of optimal predictors to developing AKI in cirrhotic patients suffering from acute GI bleeding. A number of biomarkers associated with AKI were recently described. Some studies have shown that these novel biomarkers increase with the severity of liver injury and are predictive of clinical outcomes. However, the effective prediction, definitive diagnosis and differentiation of AKI by these biomarkers are still controversial. Furthermore, there is no clinical studies focus on the applicability and potential alteration in the setting of acute gastrointestinal hemorrhage in patients with cirrhosis. Aim and significance: In this study, we aim to investigate the capability of novel renal biomarkers in predicting development of acute kidney injury, differentiating causes (between pre-renal AKI, acute tubular necrosis, and hepatorenal syndrome), and predicting the response to renal treatment as well as the hepatic and overall outcomes in patients with cirrhosis suffering from acute gastrointestinal hemorrhage.

Objective The purpose of this study is to evaluate whether there is a significant difference of early rebleeding rate (within the first 5 days after esophageal variceal ligation), late rebleeding rate (more than 5 days until 28 days after esophageal variceal ligation), and convenience level between cirrhotic patients in early diet group versus late diet group. Method This study is a single blind randomised clinical trial. Subjects will be selected based on inclusion and exclusion criteria, then the subjects will be randomly divided into 2 groups, the early diet group (clear fluid diet is initiated 1 hour after esophageal variceal ligation) and the late diet group (clear fluid diet is initiated 6 hours after esophageal variceal ligation). The intervention arm is the early diet group, while the control arm is the late diet group. The primary outcome is the early rebleeding rate. The secondary outcomes are late rebleeding rate and patient's convenience level which will be measured using Visual Analogue Scale (VAS). Expected result The expected result is there will be no difference in early bleeding rate, late bleeding rate, and convenience level between early diet group versus late diet group.

The COVID-19 outbreak has exposed many strengths and weaknesses of delivering healthcare, and we want to assess whether patients with advanced liver cirrhosis can be effectively monitored at home, to limit hospital visits and thereby their infection risks. We also wish to show that if they have new signs of clinical deterioration, that these can be picked up quickly even in the community, and can result in early review or appropriate treatment. This study has been funded by INNOVATE UK, who are seeking novel ways and technologies to improve health during the pressures of the COVID pandemic. Taking part in this study involves a consultation with the investigating doctor and being shown how to use a phone-based App and the supplied CirrhoCare equipment (Withings Watch, scales, and Blood Pressure cuff). Patients will be shown how to use the equipment for several simple daily assessments, including: Heart rate (ECG) readings via the supplied Withings Watch. This would take approximately 7-10 minutes to perform each day. Daily weight, using a special weighing scale that also measures the amount of body water and muscle percentages (takes 30 seconds to perform). Digital blood pressure measurement, using the supplied cuff. This would take approximately 2 minutes to perform daily. For all the above measurements, that are entirely automated, the patient will be guided via the mobile phone App with step-by-step video instructions. In addition, they will be given printed instructions. Individuals will be asked to perform the measurements through daily prompts built into the App, and be sent reminders, in case they forget. If they have difficulties with any of the tasks, there is also an App based support system, where they can send a message for the trial team to provide assistance. In addition to the measurements above, patients will be prompted to click on a memory testing exercise of naming animals (termed - 'Stroop test'), which will be performed after the daily morning measurements. This can take half a minute to up to four minutes to perform, depending on an individual's memory function. The equipment will be supplied will enable daily monitoring for a maximum of 3 months in this study. We will also be able to learn from the supplied watch, how much sleep and how much daily exercise patients get, which will help us assess general physical well-being. Furthermore, patients will be aksed to supply information on the amount of fluid and food they have consumed via simple 'click' functions on the App (e.g. clicking next to the picture denoting 4 glasses of water). Patients will be prompted to do this via smartphone and watch every evening. We will seek patient feedback on using the App through a brief in-App based questionnaire, after 4, 8 and 12 weeks of study. In addition, patients will fill in a quality of life questionnaire before they start using the equipment, and then again after 4 weeks and 12 weeks. These brief questionnaires are through simple drop-down menus on the App and take less than 5 minutes to complete. At the end of 12 weeks, or if individuals leave the study earlier, all the equipment will be returned to the investigating team, to analyse the data. In addition to the data that we will collect from the digital tools described above, we will also access routine blood tests performed when determined necessary by the liver doctors, as part of the standard of care.

Iron is a crucial metal whose metabolism is tightly regulated. Iron deficiency or iron overload are both deleterious at the cellular, organic and systemic levels. In line with the major role of the liver in iron homeostasis, links between iron metabolism and acute on chronic liver failure have been highlighted. Nevertheless, due to the difficulty of accurately assessing iron metabolism in this situation, therapeutic intervention on iron metabolism in this setting is currently not codified. A better understanding of these mechanisms is therefore essential, in particular by characterizing the impact of exposure to non-transferrin-bound iron in acute on chronic liver failure on short-term mortality. Overall, a better understanding of the physiopathological mechanisms of iron should allow to optimize the martial balance in this condition and also improve therapeutic approaches.

Consecutive critically ill cirrhotics with septic shock and AKI who give written informed consent will be included in this prospective study. A blood and urine sample (~10 ml) would be stored for assessing the serum cytokine profile, endotoxin levels, NT-Pro BNP, Troponin I levels, urine N-GAL before, 6 hours and at 24 hours after initiation of CRRT. Septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm Hg. A record of SVR, SVRI, global ejection fraction, extravascular lung water index and pulmonary vascular permeability index, CVP, IVC diameter and B-lines on ultrasound lung would be recorded. A record of the clearance of lactate at 6, 12 , 24 and daily till recovery or death would be performed. Patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease on hemodialysis, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.

Introduction Liver cirrhosis (LC) is irreversible fibrosis of the liver (1) and it remains a public health problem. One of the complications of the cirrhosis is hepatic encephalopathy (HE) which is defined as brain dysfunction caused by liver insufficiency. Pathophysiological mechanisms of HE are complex and multifactorial. Recognition of beginning stages of HE, such as minimal HE (mHE) is of most importance. Objectives and originality of the project Diagnosis of mHE can be challenging, time-consuming and, at least to some extent, subjective. This project will assess the role of magnetic resonance (MR) in mHE diagnosis with emphasis on multimodal imaging technique. With advanced magnetic resonance (MR) techniques, in-vivo detection of intracellular water content, estimation pH and metabolites levels with millimolar concentrations can be easily performed. This will offer to explore possible pathophysiological mechanisms of HE and to evaluate the results from previous, studies that were mainly performed on animal models or cell cultures. By our best knowledge, multimodal MR approach as the investigators propose in this application has not been yet performed. The investigators will use advanced MR techniques which are currently not available in the clinical setting and require multicenter collaboration. Methods The investigators will include 10-20 patients of both genders with hyperammonemia and mHE and 10-20 patients of both genders with HE. Diagnosis of HE will be made based on results of validated neuropsychiatric test. Age-matched and gender-matched control group with no gastrointestinal, neurological or psychiatric complaints and normal levels of ammonia in the blood. Patients with mHE/HE will be included from outpatient clinic of the Department of gastroenterology, University Medical Centre (UMC) Ljubljana. Healthy controls (HC) will be invited to join via internet advertisement. Contraindications for HC will include gastrointestinal (emphasis on liver disease), neurological or psychiatric complaints. Grade of mHE/HE will be classified according to West-Haven (WH) classification. Patients with different degree of liver cirrhosis, which will be scored with the Child-Pugh (CP) score, and with no contraindications for MR (e.g. presence of metal in body) will be included. Blood levels of liver enzymes and ammonia will be measured in all participants. MR scanning will include: T1- and T2-weighted MR, MRS (MEGA-PRESS and PRESS) in two voxels: striatum and cerebellum. Location will be double-checked by voxel position screenshots. Analysis, with voxel-positioning error compensation will be performed in Gannet (www.gabamrs.com). Moreover, high resolution diffusion weighted imaging (DWI), diffusion kurtosis imaging (DKI), quantitative susceptibility mapping (QSM) will be performed in brain as well. Liver QSM will be executed to assess iron load.

The current first-line treatment for HBV is long-term oral antiviral drugs to inhibit HBV DNA replication. First-line antiviral drugs recommended by the Chinese 2015 Hepatitis B Guidelines include ETV and TDF. This study is based on a real-world clinical cohort to retrospectively analyze the effects of ETV and TDF on the long-term (5-year) incidence of HCC in Chinese patients with chronic hepatitis B with compensated cirrhosis. The results will guide the revision of the Chinese HBV guidelines.

The cardiac abnormalities in patients with cirrhosis are already reported from the 50's, in studies of patients with alcoholic cirrhosis. Further studies have shown that these cardiac changes were caused not only by the myotoxic effects of alcohol, but also are present in many patients regardless of etiology of cirrhosis. These changes are characterized by abnormalities of systolic contraction in patients undergoing physical or pharmacological stress, changes in diastolic function and electrophysiological changes in a clinical condition known as cirrhotic cardiomyopathy. Increased QT interval and the pre-ejection time changes are common in cirrhotic patients. To date no studies have evaluated the clinical relevance of changes in the heart of cirrhotic patients, or their relationship with the prognosis of affected patients. Til now, researches are based on strict echocardiographic parameters, not including several modern methods of assessment of cardiac systole and diastole. New techniques, such as two-dimensional strain, can bring new diagnostic and prognostic information, and it is not reported in the literature. Therefore, the aim of this study is to determine the morphological and functional cardiac changes in patients with cirrhosis and their prognostic role by evaluating new echocardiographic parameters of systolic and diastolic readings.