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NCT07658794
Early allograft dysfunction (EAD) remains one of the most important complications following orthotopic liver transplantation (OLT). Currently, there is no established intraoperative biomarker that reliably predicts graft dysfunction at an early stage. Near-infrared spectroscopy (NIRS) combined with the vascular occlusion test (VOT) is a non-invasive method for assessing tissue oxygenation and microcirculatory reserve. This prospective observational study aims to investigate whether VOT-derived parameters, including desaturation slope, recovery slope and post-ischemic hyperemic area under the curve (AUC-H), can predict EAD in liver transplant recipients. Measurements will be performed at four predefined intraoperative timepoints: after induction of anesthesia, during the anhepatic phase, during the neohepatic phase and at the end of surgery. The primary outcome is the occurrence of EAD according to Olthoff criteria.
NCT05500222
This study will determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical Outcome event.
NCT02984124
This multicenter RCT of 200 hospitalized patients and their family members evaluates an "informed assent" approach to discussing cardiopulmonary resuscitation, compared to usual care, in older seriously ill hospitalized patients with severe life-limiting illness or severe functional impairment.
NCT07280390
Cirrhosis and portal hypertension are associated with an hyperdynamic circulation and hepatic inflammation, leading to complications like ascites, variceal bleeding, acute kidney injury, and higher infection risk. Microplastics (MPs) are a global plastic pollution issue, and studies have found plastic MPs or nanoparticles (NPs) contaminating human, animal and environmental ecosystems.It has been noted that the accumulation of MPs increases with a reduction in size of the plastic particle. MPs are categorized into primary particles such as manufactured plastics including pellets and cosmetic microbeads and secondary particles which originate from mechanical and ultraviolet disruption of large plastic particles. MPs can be ingested via food or beverages, especially plastic packaged comestibles or inhaled as environmental pollutants. Contamination of medications such as antibiotics, intravenous fluids, albumin and medical devices is another source of exposure to microplastics in patients with chronic liver disease (CLD)In particular exposure to endoscopic interventions, liver biopsy, and invasive procedures such as paracentesis and interventional radiology procedures can lead to plastic exposure and deposition of MPs in the liver and other tissues in patients with cirrhosis. It may be hypothesized that these may contribute to hepatic inflammation and progression of cirrhosis and portal hypertension. Globally, there is new research on the influence of MPs on the environment, plant and animal ecosystems and human health. Polystyrene (PS) microspheres that concentrate in the liver, intestine and the kidneys of mammals disrupt lipid and energy metabolism, impair mucus secretion, and alter the microbiome. Therefore, studies are required to assess how and to what extent, MPs impact human health, and affect chronic diseases like cirrhosis and reduce longevity. The study investigators will assess the presence of MPs in the liver, kidneys and intestine of patients with liver cirrhosis and compare it with those without underlying liver disease and determine the impact on portal hypertension and fibrosis, and cardiovascular and metabolic function.
NCT07590284
This study is a multicenter, prospective study. In this study, enrolled subjects are cirrhotic patients of any etiology. The US and Sonazoid CEUS monitoring strategy was performed for cirrhotic patients: US and AFP joint with Sonazoid CEUS every 4 to 6 months, and combined CECT/CEMRI every 12 months.
NCT02908048
The study will examine and evaluate the use of extracellular RNA in blood as markers for the diagnosis of liver disease or cancer, and as markers for prediction of response to treatment or recurrence of cancer after surgery
NCT06144086
This is a phase 2 trial of foscenvivint in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia to evaluate the efficacy, safety and pharmacokinetics.
NCT07560202
Portal vein thrombosis (PVT) is a common complication in patients with liver cirrhosis and is associated with increased morbidity due to worsening portal hypertension and hepatic decompensation. The clinical presentation and radiological patterns of PVT vary widely, and the factors predicting its development remain incompletely understood. This observational study will include adult patients (≥18 years) with established liver cirrhosis who are admitted to the Department of Gastroenterology and Tropical Medicine, Al-Rajhi Liver Hospital, Assiut University. Eligible participants will undergo routine screening for PVT using Doppler ultrasonography, with confirmation by contrast-enhanced computed tomography when indicated. The study aims to evaluate the clinical characteristics, laboratory parameters, and radiological features of PVT. Cases of PVT will be classified according to extent (partial or complete) and anatomical location (main portal vein, right branch, left branch, or combined involvement). Clinical and laboratory data will be analyzed to identify potential predictors associated with the development and severity of PVT. The findings of this study are expected to improve understanding of the risk factors and radiological patterns of PVT in cirrhotic patients, contributing to better risk stratification and clinical management.
NCT06345547
The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. The main question\[s\] it aims to answer are: * what is the prevalence and development of sarcopenia in cirrhosis? * what is the role of malnutrition? Participants will * undergo a muscle ultrasound of the lower and upper limb muscles * handgrip strength will be measured * malnutrition screening and assessment * complete a questionnaire to assess quality of life
NCT07069725
This is a phase 1, open-label, PET trial. The study is designed to investigate the effect of AZD2389 on FAP occupancy in the liver in participants with advanced liver fibrosis.
NCT07549607
The seladelpar registry will collect real-world data of patients with PBC diagnosis treated with seladelpar in the real-life scenario in Germany and Switzerland.
NCT07439939
Portal vein thrombosis is defined as non-tumoural obstruction of the portal vein or one of its branches. Its incidence is 0.7 to 2.7 per 100,000 patient-years in the general population, and 4.6 per 100 patient-years in patients with cirrhosis. Histological modificaitions fo the portal vein wall and haemostatic changes have been described in cirrhotic patients. The contribution of these changes, both systemic and local, to the development of portal vein thrombosis is debated. One of the hypotheses put forward on the genesis of portal vein thrombosis is as follows: certain bacterial translocations from the digestive tract, promoted by portal hypertension, contribute to endothelial activation resulting in the release of von Willebrand factor and factor VIII, as well as platelet activation and the coagulation cascade, which is dysregulated by cirrhosis and underlying changes in haemostatic balance. Inflammatory phenomena and NETosis may also be involved. Studies suggest that cirrhotic patients have lesions of the glycocalyx located in the portal area, which may be involved in the development of portal vein thrombosis. Patients with cirrhosis may benefit from the placement of a transjugular intrahepatic portosystemic shunt (TIPS). During the TIPS placement procedure, blood is drawn from the internal jugular vein and the portal vein, allowing for parallel biological analyses. The assumption of this study is that haemostasis and inflammation are disrupted differently at the systemic and portal levels in cirrhotic patients.
NCT05118308
This study will directly compare the endoscopic ultrasound guided approach to obtain adequate liver biopsies and portal pressure gradient measurements to the current standard of care which uses the transjugular approach.
NCT04383951
This is an open-label, randomized study comparing a monitored ketogenic diet intervention using standard ketogenic diet (SKD) and standard of care (SOC) dietary recommendations for 16 weeks. Subjects enrolled in the standard of care group will receive a voucher to Weight Watchers after study completion.
NCT02626312
This phase I trial studies the side effects and the best dose of radiation therapy in treating patients with hepatocellular carcinoma, cholangiocarcinoma, or cancer that has spread from the original (primary) tumor to the liver who also have impaired liver function (liver damage caused by cirrhosis, chemotherapy, or surgery). Radiation therapy (RT) uses high energy x-rays to kill tumor cells and shrink tumors. New methods of giving RT to the liver may help control cancer.
NCT05623150
The aim is to determine the metabolic factors, host immune factors, and medical imaging data associated with the development of HepatoCellular Carcinoma (HCC) in patients with alcohol-related liver disease or dysmetabolic steatosis/Non-Alcoholic SteatoHepatitis. The investigators will include patients with and without cirrhosis in order to identify early molecular mechanisms involved in the development of HCC especially in non-cirrhotic patients.
NCT07533565
This study was a prospective, interventional, pilot clinical study conducted over 3 months on cirrhotic patients with overactive bladder and asthma, evaluating the real-world applicability of selected PBPK-guided dosing regimens. Patients were stratified according to Child-Pugh class (CP-A, CP-B, and CP-C) and administered mirabegron and montelukast at doses corresponding to the closest commercially available strengths to Simcyp®-optimized doses. Clinical evaluation included number of incontinence episodes, number of micturation, volume voided per micturation, cough, and wheezing. Routine laboratory investigations were conducted to assess efficacy and safety and included liver function tests (serum albumin, total bilirubin, alanine aminotransferase \[ALT\], and aspartate aminotransferase \[AST\]), kidney function tests (serum creatinine and blood urea nitrogen \[BUN\]), and CBC.
NCT04807803
Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known. The main objective of this study is to evaluate the MHE in patients with cirrhosis and portal hypertension.
NCT06343389
In our locality, limited studies have discussed AKI in patients with liver cirrhosis and its outcome, therefore we aim to highlight the incidence, patterns, risk factors, and outcomes of acute kidney injury in patients with liver cirrhosis at Sohag University Hospital.
NCT07347275
This study is intended to demonstrate the efficacy and safety of the DIALIVE Liver Dialysis Device when incorporated into the standard management plan for participants with A-TANGO ACLF grade 2-4. A total of 72 evaluable participants, aged 18-70, will be enrolled in up to 12 clinical centres in the United Kingdom. Participants must have a history of liver cirrhosis and a deterioration within four weeks due to a precipitating event, leading to A-TANGO ACLF grade 2-4. Multicenter, individually randomised, controlled, open-label, parallel group trial using double-arm design. The control group will receive SoC for participants with ACLF. The DIALIVE 2.0 treatment group will receive SoC with the addition of up to 7 (seven) daily DIALIVE 2.0 treatment sessions within the 10-day treatment window. Seventy-two participants with ACLF (60% A-TANGO ACLF grade 2 at randomisation, and 40% A-TANGO ACLF grade 3 \& 4 at randomisation) will be randomised 1:1 to receive either SoC or SoC + DIALIVE 2.0. This allows for 5% loss due to drop-out, and 5% censoring due to liver transplantation within 28 days. All randomised participants will be included in the intention to treat (ITT) analysis while all participants that receive at least one treatment cycle will be used for the safety population. For each participant, the study duration will be up to 105 days (screening: 5 days; treatment up to 10 days; follow up 90 days). The total study duration is estimated to be approximately 18 months from screening of first participant until study completion of the last participant.