Budd-Chiari Syndrome

Researchers are investigating the use of 18F-DFA PET imaging to evaluate liver injury, a condition involving rapid liver function decline with symptoms like increased liver enzymes, jaundice, and abdominal discomfort. This observational study aims to assess how accurately this imaging method detects liver damage compared to standard clinical biochemical tests and liver biopsy, which is the current gold standard despite its sampling limitations. The study focuses on adults clinically diagnosed with liver damage or liver failure, exploring the correlation between 18F-DFA uptake in the liver and liver function indicators. Participants diagnosed with liver injury will undergo 18F-DFA PET imaging as part of the study. This radioactive tracer, based on vitamin C structure, is used to visualize liver function non-invasively. The imaging process involves a PET-CT scan lasting about 10 minutes, followed by a one-hour waiting period in the examination room before leaving. The study will compare imaging results with clinical liver function tests or liver biopsy findings to determine the sensitivity and specificity of this method. During the study, participants will have their liver function monitored using PET-CT scans and clinical biochemical markers. The primary outcomes include changes in liver uptake values on PET imaging at 6 months and the relationship between imaging results and standard liver function indicators. Participants will be followed up as needed, with assessments including liver enzyme levels and other blood tests. The total study duration depends on individual follow-up, and safety monitoring will address any issues related to PET imaging procedures.

Researchers are studying the connection between portal vein thrombosis (PVT) and outcomes after liver transplantation. The study aims to find out how common PVT is, what risk factors contribute to it, and how having PVT before surgery affects the prognosis of liver transplant patients. The goal also includes developing a new grading or rating system for PVT to improve clinical care. Participants are grouped into those with PVT and those without PVT before their liver transplant. The study does not involve any treatment or intervention but observes and compares data from both groups. Medical imaging, surgical details, pathology reports, treatments after surgery, and follow-up information will be collected and analyzed to understand PVT’s impact. During the study, researchers will gather demographic and laboratory data, imaging results, and clinical outcomes over time. The main outcomes measured include death, postoperative PVT, and portal vein narrowing over a 10-year period, along with complications within 1 year after surgery. The study monitors participants through their clinical records to build predictive models and clarify how PVT influences transplant prognosis.

Robotic surgery is an advanced technology designed to improve minimally invasive liver surgery by enhancing flexibility and precision. This research focuses on comparing robotic liver resection with laparoscopic and open liver resections to evaluate its safety and feasibility. The study aims to provide clear and relevant data about the potential benefits and challenges of using robotic systems in liver surgery. Participants will undergo robotic liver resection using the Da Vinci robotic system. The study compares this approach with traditional laparoscopic and open methods, aiming to assess differences in surgical outcomes. The robotic method is studied as a device intervention, with careful observation of its use in liver tumor removal. Throughout the study, researchers will monitor participants for complications within 90 days after surgery, including hospital stay length, any unplanned reoperations, and readmissions. These outcomes help determine the safety and recovery aspects of robotic liver surgery. Participants will be followed during this postoperative period to gather comprehensive data on their surgical experience and recovery.

Researchers are evaluating the impact of a transitional care model called the Transitional Liver Clinic (TLC) on patients with advanced liver disease who face challenges after hospital discharge. This trial seeks to reduce early hospital readmissions, improve quality of life, and enhance patient experience during this vulnerable period. The study is designed as a stepped-wedge randomized trial conducted across four large centers over 45 months, including about 1,000 patients with advanced liver disease. Participants will receive either usual care or the TLC intervention. Those in usual care will be followed by their regular providers based on discharge recommendations. Patients in the TLC group will get a phone call from TLC staff within two business days after discharge and an in-person or telehealth clinic visit with a hepatology advanced practice provider within 14 days. Additional care tailored to individual patient needs is provided during the 30-day transitional period. Each site transitions from usual care to TLC sequentially during the study periods. Participants are followed up by phone at 30 and 90 days after discharge to assess outcomes. The study measures include 30-day hospital readmission rates, quality of life using the Promis 29+2 survey, and patient satisfaction via the PSQ 18 questionnaire. Secondary outcomes include emergency room visits, mortality at 90 days, days alive outside the hospital, and hospital readmissions at 30 and 90 days. The total participation spans the hospitalization and follow-up periods, with close monitoring of patient health and experience.

Chronic liver diseases affect over 800 million people worldwide and cause about 2 million deaths each year. Early diagnosis and prediction of disease progression remain major challenges, as current blood markers and panel tests lack sensitivity and specificity. This research focuses on albumin post-translational modifications (PTM) as potential early biomarkers that may indicate future liver damage and help predict disease progression in patients with chronic liver disease. The study will recruit 756 patients with compensated fibrosis from six university hospitals and follow them for up to three years. Blood samples will be taken at the start and during follow-up visits at one, two, and three years, either through additional tubes added to routine samples or using leftover samples. These will be analyzed centrally to assess albumin isoform profiles and ligand-binding capacities using the Serum Enhanced Binding (SEB) test. Participants will have no extra visits beyond their usual care appointments. Data including blood results and medical records will be collected at each visit. Researchers will evaluate the ability of albumin modifications and the SEB test to predict liver disease progression, monitor changes over time, and confirm characteristic albumin patterns related to liver injury. The study aims to improve liver disease diagnostics and patient care by validating these novel biomarkers.

Researchers are evaluating patients with chronic liver diseases linked to hepatic steatosis, a condition where fat accumulation in the liver may cause inflammation and scarring. This condition can lead to serious liver problems such as cirrhosis, liver failure, and death. The study aims to better understand the underlying mechanisms of these diseases and to identify specific diagnostic markers and potential future treatments by examining tissue-level characteristics. This observational study involves collecting detailed biological samples and data from adults with various chronic liver diseases, including autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hereditary hemochromatosis, alpha-1-antitrypsin deficiency, and others. The study does not involve any drug or device interventions but focuses on in-depth phenotyping and metabolic assessments at multiple time points. Participants will be observed and evaluated over a period of up to 10 years. Researchers will collect plasma samples at several intervals and aim to identify diagnostic classifiers to distinguish between different chronic liver diseases. The study includes regular assessments and long-term monitoring to gather comprehensive data on metabolic disturbances and disease characteristics. Participation involves informed consent and adherence to scheduled evaluations without treatment administration.

Researchers are evaluating the safety and effectiveness of apixaban combined with carvedilol compared to carvedilol alone in preventing complications related to portal hypertension in patients with cirrhosis. This is a prospective, randomized, single-blind, placebo-controlled study conducted at the Asian Institute of Medical Sciences Hospital in Hyderabad, Pakistan. The goal is to provide local evidence for using apixaban in managing cirrhosis and its complications, such as variceal bleeding and portal vein thrombosis. Participants are randomly assigned to one of two groups: one receives apixaban 2.5 mg twice daily plus carvedilol, while the other receives a placebo plus carvedilol. Carvedilol doses start at 6.25 mg once daily and are gradually increased every 2 to 4 weeks to a target of 12.5 mg twice daily, based on heart rate and blood pressure. Those with high-risk varices undergo endoscopic band ligation before randomization for safety. The treatment and follow-up last for 12 months. During the study, participants have visits at baseline, 2 weeks, and at 1, 3, 6, 9, and 12 months. Assessments include vital signs, blood tests, abdominal ultrasound with Doppler, and transient elastography. Adherence is tracked through pill counts and diaries. Researchers will monitor the first occurrence of portal hypertension complications, bleeding events, hospitalizations, and mortality. Safety is carefully reviewed by an independent board throughout the trial.

This research aims to evaluate whether normothermic machine perfusion (NMP) can safely increase the number of usable donor livers for transplantation, helping patients get transplants faster and improving outcomes. The study focuses on patients waiting for a liver transplant with a ReMELD-Na-Score of 21 or less, who do not meet certain special exception criteria. It investigates if this new assessment method reduces waiting time and improves survival and health after transplant. Participants are randomly assigned to one of two groups. The experimental group may receive livers initially declined by all German transplant centers but deemed suitable after at least four hours of NMP quality assessment. The control group receives livers through the usual transplant process. Declined livers are selected based on specific quality criteria such as steatosis less than 60%, fibrosis grade up to F3, and graft weight between 1 and 2.5 kg. During the study, researchers track how quickly participants receive a transplant as the main outcome. They also monitor survival rates, disease progression, recovery on the waitlist, quality of life, graft utilization, hospital stay costs, and complications up to 24 months after randomization. Participants will be followed for up to 12 months to observe transplant timing and up to 24 months for longer-term outcomes.

Researchers are evaluating how well neural networks trained on ultrasonic raw radiofrequency data can assess liver diseases in patients undergoing clinical ultrasound exams. The study aims to compare the performance of these neural networks against elastography and those trained on b-mode ultrasound images, as well as to see if they can distinguish focal liver lesions from healthy tissue. This research is conducted with patients who have a clinical indication for elastography or suspected liver lesions and involves collecting detailed ultrasound data for analysis. Participants scheduled for elastography will have both b-mode images and radiofrequency data collected during their ultrasound scans. For those with suspected focal liver lesions, ultrasound data is collected along with a definitive diagnosis obtained through standard clinical procedures such as contrast-enhanced ultrasound, biopsy, MRI, or CT, depending on what is normally done at the participating center. The study includes two groups: one focused on elastography data collection and another on focal lesion evaluation, all without randomization or masking. During the study, participants undergo clinical ultrasound examinations to capture both b-mode images and corresponding radiofrequency data. Additional tests or procedures may be performed to confirm diagnoses for focal liver lesions. Researchers will analyze the performance of the trained neural networks after the study concludes, approximately one year later. The total participation time varies, with assessments aligned to routine clinical care. Safety monitoring includes exclusion of recent liver interventions to avoid confounding results.

Researchers are evaluating a new combination treatment for patients with advanced liver cancer known as Barcelona Clinic Liver Cancer (BCLC) stage C hepatocellular carcinoma (HCC), specifically those with portal vein tumor thrombus (PVTT) or limited spread outside the liver (oligometastases). This Phase II study aims to see if combining hepatic artery infusion chemotherapy (HAIC) with immunotherapy drugs iparomlimab/tuvonralimab and bevacizumab, followed by focused radiotherapy, can improve survival and disease control while maintaining quality of life and safety. The treatment includes up to four cycles of HAIC, where chemotherapy drugs are delivered directly into the liver artery over 2-3 days every three weeks. Alongside this, patients receive intravenous bevacizumab every three weeks, followed by iparomlimab/tuvonralimab, also every three weeks. After these cycles, patients undergo stereotactic body radiotherapy (SBRT) delivering 25-40 Gy in 5 sessions over 1-2 weeks to target tumors in the liver, portal vein, or limited extrahepatic lesions. The regimen is designed to act together to reduce tumor burden and enhance immune response. Participants will be closely monitored through various assessments during and after treatment, including imaging to measure tumor response and disease progression over at least two years. Researchers will track progression-free survival as the main outcome, along with overall survival, response rates, disease control, local tumor control, adverse events, and quality of life changes. The study will evaluate safety and treatment-related side effects over five years, with detailed follow-up to assess long-term outcomes of this combined approach.