Portal Hypertension

Researchers are studying the metabolism of cells in the ascites fluid of ovarian cancer patients to better understand the tumour environment. This observational study involves women aged 18 and older who have ascites caused by diagnosed ovarian cancer. The study aims to trace how glucose is taken up and metabolized by tumour and T cells in the ascites. Participants will receive an intravenous infusion of specially labeled glucose ([U-13C]glucose) during their scheduled paracentesis procedure. The infusion starts with 8 grams of labeled glucose in 60 mL over 10 minutes, followed by 4 grams in 30 mL over one hour, continuing until the ascites fluid is drained or up to 5 hours. A continuous glucose monitor tracks blood glucose levels throughout. Samples of ascites fluid collected during the infusion will be kept on ice and analyzed for metabolic activity and metabolite profiles using flow cytometry and mass spectrometry. During the study, participants will wear a glucose monitor before paracentesis and have ascites fluid collected hourly for up to 5 hours. Researchers will measure glucose enrichment and compare metabolic pathways in different cell types within the ascites. They will also correlate metabolic profiles with T cell function. The study involves close monitoring of blood glucose and sample analysis to understand tumour and immune cell metabolism in ovarian cancer ascites.

Researchers are studying the use of spleen shear wave elastography (SWE-SSM) to help diagnose significant portal hypertension and high-risk esophageal varices in patients with advanced compensated chronic liver disease. The study aims to understand how well SWE-SSM can identify these conditions without affecting patient treatment or disease progression. It also explores how SWE-SSM relates to portal pressure and transient elastography measurements in some patients. During the ultrasound exams that patients normally undergo, spleen elastography will be added if the patient meets study criteria and consents. This additional test is non-invasive and does not change the standard ultrasound procedure or patient care. No treatments or experimental interventions will be given, as the study focuses on collecting clinical data through observation. Participants will have ultrasound exams including both spleen and liver elastography as part of their usual care pathway. Researchers will evaluate measurements related to portal hypertension and esophageal varices over a two-year period. The study monitors the natural course of the disease and gathers data without altering treatments or clinical management.

Researchers are investigating new non-invasive methods to predict hepatic venous pressure gradient (HVPG), a key measure in managing portal hypertension in cirrhosis. This study compares three-dimensional magnetic resonance elastography (3D-MRE) with two-dimensional magnetic resonance elastography (2D-MRE) to develop a risk stratification system that can guide personalized treatment for portal hypertension. Cirrhosis and portal hypertension pose significant health challenges, making less invasive diagnostic tools important for patient care. Participants will undergo imaging using either 3D-MRE or 2D-MRE, both performed on a 3.0-T MRI system with an eight-channel body coil. The study features two groups: one developing a model using 3D-MRE and a control group using 2D-MRE. Hepatic venous pressure gradient measurements are taken by trained radiologists following standard procedures. Comparing these imaging techniques aims to evaluate their accuracy in assessing portal hypertension. During the study, participants will have imaging and HVPG measurements within one month to ensure data consistency. Researchers will assess the accuracy of 3D-MRE and 2D-MRE features for predicting portal hypertension over a 12-month period. The study monitors participants through these diagnostic tests and evaluates how well the imaging models can predict HVPG, contributing to safer, more convenient management of cirrhosis-related complications.

Researchers are evaluating a new, non-invasive method using three-dimensional magnetic resonance elastography (3D-MRE) to predict hepatic venous pressure gradient (HVPG) in patients with cirrhosis, portal hypertension, or advanced chronic liver disease. This study aims to establish a risk stratification system to better manage portal hypertension, a critical factor affecting the prognosis of these liver conditions. The trial is observational and focuses on improving diagnosis without invasive procedures like liver biopsy or traditional HVPG measurement. The study involves two groups: a training cohort to develop the new 3D-MRE model for virtual HVPG prediction, and a validation cohort to confirm the model's accuracy in different patients under similar conditions. Imaging is done using a 3.0-T MRI system with a phased-array body coil, while HVPG measurements are performed by skilled interventional radiologists following standard procedures. Participants undergo both assessments within one month. During the 12-month study, participants will have their portal hypertension assessed through the features of 3D-MRE and HVPG readings. Researchers will analyze the accuracy of 3D-MRE to predict portal hypertension levels. Participants provide informed consent and meet age and health criteria. The study includes monitoring to ensure reliable imaging and measurement results, with exclusion of those with conditions or treatments that may affect accuracy. The total participation involves these diagnostic steps, with no treatment interventions administered.

Researchers are investigating early detection and risk assessment of hepatocellular carcinoma (HCC) in adults with advanced liver disease, specifically those with liver cirrhosis from various causes. This prospective multicenter study aims to compare ultrasound and abbreviated MRI (AMRI) as surveillance tools to assess their ability to detect HCC, as well as to study how body composition, such as fat and muscle levels, relates to disease progression and HCC risk. Participants with cirrhosis undergo regular clinical evaluations and imaging tests at set intervals, including ultrasound and abbreviated MRI scans. The study collects detailed data on body composition and tracks clinical outcomes like liver-related complications and mortality. These assessments occur over multiple visits, including baseline and follow-ups at 6, 12, and 18 months, with additional monitoring for up to 24 months to observe new cases of HCC and disease progression. During the study, participants receive structured exams, imaging, and body composition measurements at each visit. Researchers evaluate lesion risk for HCC using LI-RADS criteria and measure muscle mass through the Muscle Assessment Score. They also monitor liver stiffness and organ volumes at baseline and follow-up visits. The study's goal is to develop prediction models based on these clinical and imaging data to better understand HCC risk and liver disease progression over time.

Researchers are evaluating a new combined therapy using human albumin and enoxaparin in patients with decompensated cirrhosis who are discharged from the hospital. The study aims to determine if this combined treatment is safe, tolerable, effective, and whether it costs more or less compared to standard medical treatment. This Phase 2 clinical trial will compare patients receiving the combinatorial therapy plus standard care to those receiving only standard care to see how they respond over time. Participants are randomly assigned to one of two groups: one group receives standard medical treatment along with the combined therapy of enoxaparin and human albumin, while the control group receives only standard medical treatment. The study involves treatment and follow-up over a period that includes monitoring at 30, 90, and 180 days after baseline to assess various health outcomes and complications. During the study, participants will attend visits where researchers will perform tests to track disease progression and response to treatment. Assessments include monitoring adverse events such as pulmonary edema, bleeding, and thrombocytopenia, as well as changes in liver and kidney function, hospital readmissions, survival rates, quality of life measures, and overall healthcare costs. Safety and tolerability are closely observed from baseline to day 90, with continued evaluation up to 180 days. Total study participation may last about six months from baseline.

Researchers are evaluating the efficacy of intravenous OsrHSA compared to a positive control human serum albumin (HSA) in patients with decompensated cirrhotic ascites. This Phase II, multicenter, randomized, double-blind study aims to assess how well OsrHSA raises serum albumin levels and its safety and tolerability over a 14-day treatment period. Participants are stratified based on their baseline serum albumin levels to guide treatment continuation. Participants are randomly assigned in a 4:1 ratio to receive either OsrHSA or the positive control HSA at doses of 10 g or 20 g once daily via intravenous infusion for 14 days. The study includes multiple cohorts receiving these doses, with blinding maintained for both investigators and participants. Treatment may be stopped early if serum albumin levels reach 35 g/L or higher. After treatment, participants undergo three follow-up visits over two weeks to monitor progress. During the study, participants will be regularly evaluated for efficacy, safety, tolerability, and immune response to the treatments. Researchers will measure serum albumin levels to determine treatment effectiveness. The total participation duration includes up to 14 days of screening, 14 days of treatment, and follow-up visits over two weeks. The study tracks laboratory tests, clinical assessments, and adverse events to support comprehensive monitoring throughout the trial.

Researchers are studying patients with cirrhosis caused by alcohol-related or metabolic dysfunction-associated steatotic liver disease (MASLD). The trial aims to evaluate whether taking capsules containing faecal microbiota from healthy donors can reduce infections and mortality in these patients. This Phase 3 trial follows earlier research that showed faecal microbiota transplantation (FMT) delivered via endoscopy was safe and feasible, leading to the development of capsules for easier treatment administration. Participants will be randomly assigned to receive either encapsulated FMT or placebo capsules that look identical but contain no active treatment. They will take five capsules every three months over a total period of 21 months or until they develop an infection requiring hospital admission. This double-blind trial means neither participants nor study staff will know which treatment is given. The study will last up to 24 months including follow-up, monitoring effects on infection rates, liver health, immune system function, and antibiotic resistance. Throughout the trial, participants will be regularly assessed for infections, liver disease progression, hospital admissions, quality of life, mental health, alcohol use, and safety of FMT treatment. Laboratory tests will examine immune response and bacterial resistance. The primary outcome is the time until first infection needing hospital care. The study involves detailed monitoring and follow-up visits for up to two years to understand the treatment’s impact and safety in patients with cirrhosis.

Researchers are evaluating the use of memantine, a single drug, in patients with unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC) who also have cirrhosis and are not candidates for intensive systemic therapy. This prospective study aims to describe the drug's effects on disease progression and quality of life over time. The study is sponsored by Inova Health Care Services and focuses on patients with a Child-Pugh cirrhosis score of B7 or higher and an Eastern Cooperative Oncology Group performance status of 0-2. Participants will receive memantine starting at 5 mg by mouth once daily, with doses increased up to 20 mg daily as tolerated. The study is conducted at a single site and follows patients through treatment to assess efficacy endpoints, including progression-free survival at 6 months. The treatment plan excludes aggressive systemic therapies and allows palliative radiation for symptom control. During the study, participants will be monitored for disease progression and quality of life changes. Assessments include measuring tumor lesions by RECIST 1.1 criteria and ensuring adequate blood counts and organ function. Safety is closely observed, especially regarding pregnancy risks, cardiovascular health, and other medical conditions. The study continues until August 31, 2026, with ongoing evaluations at defined intervals.

Researchers are evaluating the effectiveness of bariatric surgery compared to standard medical treatment in obese patients with nonalcoholic steatohepatitis (NASH) complicated by advanced liver fibrosis (grades F3 and F4). This study aims to show whether bariatric surgery leads to the disappearance of NASH without worsening fibrosis in patients with a body mass index (BMI) between 30 and 35 kg/m² for F3 fibrosis, and between 30 and 50 kg/m² for F4 fibrosis. The trial is open-label and randomized, designed to compare surgical intervention with lifestyle therapy.