Ascites

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 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.

Chronic subdural hematoma (CSDH) is a common condition often treated by neurosurgical evacuation and drainage of the hematoma. This research aims to compare two drainage methods after surgery: 24 hours of active subperiosteal drainage versus 24 hours of passive subdural drainage. The study is a nationwide, randomized clinical trial conducted across all neurosurgical units in Denmark to evaluate if active drainage is not worse than passive drainage in terms of safety and recurrence. Participants will be adults with symptomatic unilateral CSDH undergoing single burr hole evacuation. Before surgery, patients will be randomly assigned to receive either 24 hours of active subperiosteal drainage or 24 hours of passive subdural drainage. Both drainage methods are already in use, but a direct comparison has not been done. The trial will monitor patients for 90 days post-surgery to assess outcomes. During the study, participants will be evaluated for mortality and recurrence of CSDH requiring reoperation within 90 days. Other assessments include complications related to surgery, length of hospital stay, and functional outcomes measured by the simplified modified Rankin scale. The study uses a double-blind design for patients and statisticians and plans to enroll 354 participants over approximately two years.

Researchers are evaluating intraperitoneal perfusion with Docetaxel Polymeric Micelles (SIM0388) for patients with malignant ascites, a common complication of malignant tumors. This phase I study aims to assess the safety, efficacy, and pharmacokinetic features of SIM0388 in this condition. The study includes both dose escalation and dose expansion parts to better understand the treatment's effects and appropriate dosing. The trial begins with a dose escalation phase to determine the maximum tolerated dose and recommended dose(s) of SIM0388 given via peritoneal perfusion. After establishing the dose, a dose expansion phase will evaluate the treatment's effectiveness in managing malignant ascites. Participants receive sequential cohorts of increasing doses or the recommended dose(s) of SIM0388 as monotherapy through abdominal perfusion. Participants will be monitored for safety, tolerability, and response to treatment over an average of two years. Assessments include observing dose-limiting toxicities, adverse events, objective response rate in ascites, time to progression in ascites, and puncture/drainage-free survival. The study involves regular evaluations including physical exams, imaging, laboratory tests, and monitoring of treatment effects to gather comprehensive data on SIM0388's impact.

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 evaluating the safety of siplizumab, an investigational anti-CD2 monoclonal antibody, as an induction immunosuppressive treatment in adult patients with autoimmune liver diseases (AILD) such as autoimmune hepatitis (AIH) and primary sclerosing cholangitis (PSC) undergoing liver transplantation. This pilot, open-label phase 1 study addresses the need for effective therapies to prevent immune-mediated graft injury and complications post-transplant. Siplizumab targets memory T cells involved in rejection and autoimmunity after liver transplantation in these patients. Participants will receive two intravenous doses of siplizumab at 0.6 mg/kg: one dose intraoperatively on the day of transplant (Day 0) and another on Day 4 post-transplant. Up to eight subjects will be enrolled. The study lasts about 15 months, including approximately three months waiting for transplant and 12 months of follow-up after transplantation. During the study, participants will be monitored for serious infections within the first month after transplant and for other outcomes such as immune-mediated liver injury, graft loss or death, rejection episodes, donor-specific antibodies, and disease recurrence over 12 months post-transplant. Assessments will include safety, tolerability, pharmacokinetics, and pharmacodynamics of siplizumab, with ongoing observation throughout the study period.

Researchers are investigating the relationship between the volume of normal liver tissue removed during surgery, called resected normal liver parenchymal volume (RNLV), and the risk of liver failure after liver surgery (post-hepatetotomy liver failure, or PHLF). This observational study focuses on patients diagnosed with hepatocellular carcinoma (HCC) or intracholangiocarcinoma (ICC) who have undergone liver resection. The goal is to build and assess a personalized predictive model using RNLV to better estimate the risk of PHLF before surgery. The study collects data retrospectively from over a thousand patients treated at the investigator’s center. Patients are grouped based on whether they developed liver failure after surgery, defined by two sets of criteria known as the 50-50 criteria and ISGLS criteria. The research evaluates how well the RNLV-based model predicts PHLF and compares its usefulness to other methods, especially for patients with large or multiple liver tumors. Participants' medical records and surgical details are reviewed to calculate RNLV and assess liver failure outcomes within 30 days after surgery. The main outcome is the predicted probability of PHLF using the newly developed model. This approach aims to improve preoperative risk assessment to support safer liver surgeries. The study is sponsored by the National Natural Science Foundation of China and runs through the end of 2026.

Researchers are conducting a prospective, single-center, randomized controlled trial to study patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). The trial aims to evaluate how total splenectomy affects the effectiveness of debridement surgery, recovery during the perioperative period, and the overall prognosis for these patients. This study plans to enroll 66 participants and compares two surgical approaches to better understand their impacts on patient outcomes. Participants will be randomly assigned to one of two groups: one receiving open debridement combined with distal pancreatectomy and total splenectomy, and the other receiving open debridement alone. The study will observe differences in recovery and prognosis between these two surgical methods, focusing on hospital stay length, treatment costs, life quality after surgery, and improvement in PSPH. Secondary outcomes include monitoring infection control, antibiotic use, drainage management, platelet count changes, and the frequency of additional operations or readmissions. During the study, participants will be closely monitored from enrollment until up to five years after surgery. Researchers will track hospital stay durations, intensive care unit time, and complications like pancreatic fistula. Life quality will also be assessed up to one year after treatment. Data on postoperative costs, drainage tube removal, antibiotic use, and abdominal lavage will be collected to evaluate surgical recovery. This comprehensive follow-up will help assess the overall impact of the surgical options on patient health and recovery.

The trial investigates the development of cardiac decompensation in patients with ethyltoxic liver cirrhosis who undergo transjugular intrahepatic portosystemic shunt (TIPSS) implantation. It aims to determine how often cardiac decompensation occurs within one year and to identify associated laboratory, clinical, or imaging changes. This research evaluates these risks to improve future treatment decisions and selection criteria for TIPSS implantation. Participants will receive three additional cardiac magnetic resonance imaging (MRI) scans with measurements of cardiac function, T1 and T2 relaxation times, and 4D-Flow sequences assessing aortic and pulmonary artery flow. Extended echocardiographic exams will be conducted before, 3 days after, and 3 months after TIPSS implantation. Blood samples will be collected at multiple time points before and after the procedure to analyze inflammatory, endothelial, and cardiac remodeling markers. During the study, participants will undergo standardized clinical TIPSS implantation alongside detailed cardiac assessments including MRI and echocardiography. Researchers will monitor right and left heart function, flow parameters, and laboratory markers for up to 12 months. The main outcome measure is the frequency of cardiac decompensation over one year. Secondary outcomes include heart function changes and correlations with laboratory markers. Safety and clinical status will be closely observed throughout the study period.