Clinical Research Directory

Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis

The study aims to compare the potential benefit of allopurinol versus atorvastatin in reducing the risk of developing cirrhosis-related complications, delaying the onset of hepatocellular carcinoma, and improving survival. Furthermore, the study aims to evaluate their impact on parents' related quality of life.

Proximal Splenic Artery Embolization (PSAE) for the Treatment of Refractory Ascites in Decompensated Cirrhosis

The purpose of this study is to learn whether a procedure called Proximal Splenic Artery Embolization (PSAE) can lower the need for repeat fluid drainage in adults with cirrhosis and a buildup of fluid in the abdomen (ascites) that is no longer controlled by water pills and diet. Participants in this study have already been told that a standard procedure called Trans jugular Intrahepatic Portosystemic Shunt (TIPS) is not a safe option for them. The main objectives this study aims to answer are: * Does PSAE lower how often participants need paracentesis, the procedure used to drain fluid from the abdomen? * Does PSAE lower the total amount of fluid drained each month? * Does PSAE change the pressure inside the liver's veins and the blood flow in the liver and spleen? * Does PSAE improve day-to-day symptoms, quality of life, strength, and the ability to do usual activities? * What side effects or complications happen with PSAE in this group of people? Participants will: * Undergo one PSAE procedure, during which small coils and/or plugs are placed in the artery that supplies the spleen to slow its blood flow * Have a pressure measurement taken in the liver's veins right before and right after the procedure, with a repeat measurement at 1 month * Attend follow-up visits at 1, 3, and 6 months that include blood tests, ultrasounds, symptoms and quality-of-life questionnaires, and a review of any paracentesis sessions since the last visit * Have a Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) and an ultrasound of the liver and spleen blood vessels at the start of the study and again at 6 months

Gut Leakage' in Dengue

Dengue infections are imposing an increasing global burden of disease, particularly in tropical countries such as Bangladesh. The World Health Organization (WHO) has identified Dengue virus as a priority pathogen for the development of medical counter measures because of the high risk of it causing a Public Health Emergency of Intenational Concern (PHEIC). Warning signs for severe dengue, associated with mortality, include gastrointestinal features including abdominal pain, vomiting, and diarrhoea. Multiple alterations may occur in in the gastrointestinal tract that could lead to damaging of the gastrointestinal wall and gut leakage, the translocation of gut metabolites into the bloodstream. Study team hypothesize that gut leakage initiates inflammatory processes underlying the further development of severe dengue, including features associated with plasma leakage. This study aims to investigate intestinal barrier dysfunction (gut leakage) in dengue infection by detecting the translocation of gut-derived bacteria and their products (Lipopolysaccharides, LPS binding protein, sCD14, I-Fatty Acid Binding Protein) into the bloodstream. Study team will recruit hospitalized adult dengue patients (18 years and older) presenting with warning signs or severe disease in a tertiary care public hospital at Chattogram, Bangladesh. Circulating biomarkers indicative of gut permeability and microbial translocation will be measured to assess their presence and association with disease severity. Abdominal ultrasonography will be performed to characterize gastrointestinal alterations and determine their correlation with biochemical markers of gut leakage and clinical severity. In addition, study team will analyze the gut bacteriome from stool/ rectal swab of these patients to explore whether dengue infection induces compositional changes in intestinal microbiota and whether such alterations are linked to gut leakage or disease progression.

Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®

A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and failures in the presence of liver cirrhosis (Acute-on-Chronic Liver Failure, ACLF) and accumulation of fluid in the abdominal cavity (ascites)

Comparing Ascites Relief In Two Standard Treatments: Large Volume Paracentesis Vs. Early Tips Using Viatorr Controlled Expansion Stents

For this study, the investigators will be collecting data based on patients' random selection to two different approved standard of care treatments for ascites: Subjects will get randomized into either Group A: Large Volume Paracentesis (LVP) with albumin infusion, or Group B: an early transjugular intrahepatic portosystemic shunt (TIPS) procedure.

High Dose Albumin in Refractory Ascites

Advanced cirrhosis with complications is a serious problem imposing a heavy financial burden on health care system. Moreover, ascites is associated with increase in mortality rates among cirrhotic patients. Ascites pathogenesis is multifactorial including: portal hypertension; splanchnic and peripheral arterial vasodilation; and neurohumoral activation. Current management strategies include dietary sodium restriction and diuretic therapy, however, this strategy put patients at the risk of intravascular volume depletion, renal impairment, hepatic encephalopathy and hyponatremia. Moreover, around 10% of patients do not respond to this strategy (termed: diuretics resistant) with 50% of them die within 6 months. This sub-group is managed by frequent large volume paracentesis along with intravenous albumin administration and are usually considered for liver transplantation (LT) and TIPS. Nonetheless, Frequent paracentesis increases the risk of infection, bleeding, bowel perforation, paracentesis-induced circulatory dysfunction (PICD) and renal dysfunction in this sub-group of patients. The beneficial effect of human albumin might result from blood volume expansion tapering activated vasoconstrictor and sodium-retaining systems improving renal perfusion, hence regular infusion of albumin may be beneficial to prevent development of ascites and to improve survival. The positive effects of albumin are supported by previous studies; Romanelli et al, showed a significant increase in survival rate among cirrhotic patients with ascites when compared to those who did not receive albumin. Moreover, a randomized multicenter open label trial published in lancet last year, demonstrated that long term albumin administration improved 18-month survival, decreased the use of paracentesis and decrease in the incidence of cirrhosis related complications among cirrhotic patients with ascites. As of today, there's a limited use of regular high dose albumin in cirrhotic patients with ascites in US, despite being used elsewhere in the world as previously stated. The investigators wish to study long-term efficacy of human albumin administration in patients with decompensated cirrhosis to assess safety and efficacy, and prevention of complications of cirrhosis.

Ultrasound Assessment of Diaphragmatic Structure and Function in Patients With Liver Cirrhosis: A Point-of-Care Tool for Predicting Complications and Sarcopenia in Limited Resource Settings

The goal of this observational study is to learn how liver cirrhosis affects the diaphragm, the main muscle used for breathing, in adults. The study will measure diaphragmatic thickness, thickening fraction, and excursion using bedside ultrasound and compare these values between patients with cirrhosis and healthy volunteers. The main questions it aims to answer are: Do patients with cirrhosis show reduced diaphragmatic function compared to healthy adults? Does removal of ascitic fluid by paracentesis improve diaphragmatic mechanics? Can ultrasound measurements of the diaphragm serve as a reliable non-invasive marker of sarcopenia when compared to CT scans? Participants will: Undergo diaphragmatic ultrasound during quiet and deep breathing Provide clinical and laboratory data related to liver disease severity In some cases, have ultrasound repeated before and after paracentesis For patients with hepatocellular carcinoma, CT scans will be analyzed to measure muscle mass

Kinesio-Taping vs. Usual Care for Malignant Bowel Obstruction With Ascites

The goal of this clinical trial is to find out whether abdominal Kinesio-taping is a feasible and effective way to relieve symptoms in patients with malignant bowel obstruction and ascites who still have severe symptoms after surgery, medication, or nasogastric tube treatment. The main questions it aims to answer are: * Can abdominal Kinesio-taping reduce the severity of symptoms, such as abdominal pain, bloating, and nausea, in these patients? * Is abdominal Kinesio-taping a safe and practical treatment option for this patient group? Participants in this study are adults with cancer who have been diagnosed with malignant bowel obstruction and ascites, and whose symptoms have not improved after standard medical treatments. People who are allergic to tape, have abdominal wounds, are pregnant, or are unable to provide consent will not be included. Participants will be randomly assigned to one of two groups: * The Kinesio-taping group will receive standard care for malignant bowel obstruction plus abdominal Kinesio-taping, applied by trained professionals using a standardized procedure. * The control group will receive standard care only. The main outcomes measured will be changes in symptom severity using the Edmonton Symptom Assessment System (ESAS) modified for ascites, as well as abdominal girth and pain medication use. Symptoms and side effects will be closely monitored to ensure safety. The information from this study may help determine whether Kinesio-taping can be an additional, safe, and effective option for managing symptoms in patients with advanced cancer who have malignant bowel obstruction and ascites.

Free Fluid Detection With Telementored eFAST

This feasibility study will evaluate the accuracy of telementored eFAST (Extended Focused Assessment with Sonography in Trauma) in detecting abdominal free fluid in patients who have recently undergone liver surgery. The primary goal is to determine how well the remote-guided ultrasound can identify fluid accumulation compared to conventional ultrasound performed by a radiologist. Participants in this study will be examined with ultrasound, supported in real-time by a remote expert, to assess its accuracy and other relevant performance metrics.

Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis

The APIXABAN-PK trial is a prospective, randomized, single-blind, placebo-controlled study designed to evaluate the efficacy and safety of apixaban in combination with carvedilol versus placebo with carvedilol in preventing portal hypertension-related complications in patients with cirrhosis. Conducted at the Gastroenterology and Hepatology Department and Clinical Trials Unit (CTU) of Asian Institute of Medical Sciences (AIMS) Hospital, Hyderabad, Pakistan, the trial will enroll eligible cirrhotic patients with portal hypertension. Participants will be followed for 12 months to monitor hepatic decompensation events, variceal bleeding, portal vein thrombosis, and mortality, while safety and tolerability of apixaban will be closely assessed. This study aims to provide local evidence for apixaban use in cirrhosis management in Pakistan.

Intraperitoneal SK-NK Cell Injection for Advanced Ovarian Cancer With Massive Ascites

This is a single-center, open-label, Phase I/II clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of SK-NK Cell Injection administered via intraperitoneal (IP) perfusion in patients with advanced ovarian cancer complicated by massive ascites . The study focuses on patients who have failed standard therapies and are suffering from severe ascites. The treatment involves the direct infusion of allogeneic, highly activated Natural Killer (NK) cells (SK-NK) into the abdominal cavity . The study consists of two phases: Phase I (Dose Escalation): To determine the safety profile and the Recommended Phase 2 Dose (RP2D) using a "3+3" design with three increasing dose levels. Phase II (Dose Expansion): To further evaluate the efficacy of the treatment in controlling ascites and suppressing tumor growth at the determined RP2D. Participants will receive the study treatment once weekly for 4 weeks.

VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)

This Registry will look at patients being treated with a transjugular intrahepatic portosystemic shunt (TIPS) procedure for portal hypertension. The purpose of this Registry is to collect data on the safety and performance of the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) for 2 years in real world setting. Additionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.

Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China

The goal of this clinical trial is to evaluate the application of intravenous contrast-enhanced ultrasound examination in children with intra-abdominal diseases that require clear diagnoses. The main questions it aims to answer are: * Is intravenous contrast-enhanced ultrasound helpful for the diagnosis of intra-abdominal diseases in children? * What medical problems do participants have when participating in intravenous contrast-enhanced ultrasound examination? * How can ultrasound doctors conduct intravenous contrast-enhanced ultrasound examinations in a standardized manner? Researchers will performing intravenous contrast-enhanced ultrasound examinations on participants and collecting research subjects to establish a multicenter clinical data database. Participants will: * Perform abdominal ultrasound examination to assess the condition. * At least conduct one intravenous contrast-enhanced ultrasound examination. Based on the result of the contrast examination, decide whether to conduct another examination. * Keep a diary of their symptoms and therapeutic process in 30 days.

VICIS - Vienna Cirrhosis Study

Patients with advanced chronic liver diseases treated at the Vienna General Hospital of the Medical University of Vienna will be offered to participate in this prospective observational trial - including an optional participation in a biobank. Clinical parameters and laboratory parameters will be recorded for all patients and patients will undergo a regular follow-up schedule with clinical visits at the Vienna General Hospital. This study is linked to a biobank with serum/plasma, ascitic fluid, urine, GI tract mucosal biopsies, liver biopsies and stool collected from the study participants.

Application of Bacterial DNA Quantitative Detection in Diagnosis of SBP in Cirrhosis: A Multi Center Diagnostic Experiment

Background and Significance: Spontaneous bacterial peritonitis (SBP) is a common and life-threatening complication in patients with liver cirrhosis, characterized by high incidence and mortality. The current diagnostic standard relies on ascitic fluid polymorphonuclear leukocyte (PMN) count ≥250 cells/μL. However, this threshold is associated with high rates of missed diagnoses, poor correlation with clinical symptoms, and delays in pathogen identification due to the low sensitivity and prolonged time of traditional ascitic fluid culture. With the development of molecular diagnostics, bacterial DNA (bactDNA) detection-especially through droplet digital PCR (ddPCR)-has emerged as a promising technique due to its high sensitivity, absolute quantification capability, and robustness. This study aims to evaluate the diagnostic value and accuracy of ddPCR-based quantification of bacterial DNA in ascitic fluid for SBP, providing a novel and objective diagnostic tool to improve early and accurate detection and to inform targeted antimicrobial therapy. Objectives: To assess the diagnostic accuracy (sensitivity, specificity, predictive values) of ddPCR-based quantification of total bacterial DNA in ascitic fluid for SBP. To evaluate the diagnostic performance of the ratio of Gram-positive to Gram-negative bacterial DNA (G+/G-) in predicting SBP. To explore the potential of ddPCR-based bacterial DNA quantification as a complementary or alternative method to conventional PMN-based diagnostic criteria. Study Design and Methods: This is a prospective diagnostic study involving 700 patients with liver cirrhosis and ascites. Ascitic fluid samples will be analyzed using ddPCR to quantify bacterial DNA levels. These results will be compared with traditional diagnostic criteria, including PMN counts and expert panel assessments based on clinical symptoms and laboratory findings. Statistical analyses will include correlation analysis, ROC curve analysis, and consistency testing. Expected Outcomes: The study aims to establish the clinical efficacy of ddPCR-based quantification of bacterial DNA in ascitic fluid as a novel diagnostic marker for SBP. This method is expected to be particularly useful in atypical cases where PMN counts are \<250/μL and may help guide preliminary antibiotic selection based on the proportion of Gram-positive and Gram-negative bacteria, thereby reducing empirical treatment failures and antibiotic resistance.

Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients

The hypothesis is that the Alfapump® strategy would be more effective in terms of QALYs generated , and that the cost of Alfapump® device and its implantation will be totally or partially offset by the reduction in the number of evacuating parentheses performed and the reduction in the number of complications in patients with refractory ascites awaiting liver transplantation or not. On the other hand, given the difference in the clinical profiles of these two populations (whether or not they are awaiting transplantation), these two populations will be study separately Evaluation of the medical-economic impact at 1 year of the two therapeutic strategies: implantation of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with refractory ascites without scheduled liver transplantation.

Drug Sensitivity of Hydrothorax and Ascite Organoids from Breast Cancer

Malignant hydrothorax and ascitic fluid in advanced breast cancer often arise from metastasis to the lungs, pleura, or liver. Patients with this condition experience rapid disease progression and multidrug resistance, facing limited treatment options. Clinical guidelines offer various therapies based on molecular subtypes; however, their effectiveness can be hindered by prior treatments, patient health, and tumor evolution. Current evaluations of treatment efficacy typically take two cycles, delaying the recognition of ineffective therapies and resulting in unnecessary side effects and costs. Organoid models present a promising solution, accurately replicating tumor structure and cellular diversity compared to traditional methods. These patient-derived models facilitate improved drug sensitivity testing, leading to more personalized treatment plans. In this study, 90 patients diagnosed with metastatic breast cancer accompanied by hydrothorax and ascitic fluid will be recruited. Patient-derived organoids will be used to assess the sensitivity of chemotherapy regimens, including Doxorubicin, Carboplatin, Cyclophosphamide, and Paclitaxel, along with targeted therapies such as Herceptin and Pertuzumab.

High Definition Profiling of Ovarian Cancer Ascites

This project entails the collection of a prospective cohort of ascites (AS) samples from High Grade Serous Ovarian Cancer (HGSOC) patients. High Grade Serous Ovarian Cancer (HGSOC) is a major cause of cancer-related mortality, due to the late-stage diagnosis and failure of surgery and chemotherapy (CHT) to eradicate the disease with no significant improvement in overall survival. The primary objective of the project is to generate a comprehensive map of ascites cell components, detailing both their intrinsic features and the landscape of cellular interactions mediated by soluble factors in ascitic fluid.

13C-Glucose Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients.

The objective of the study is to investigate the metabolism of cells in the ascites tumour microenvironment of ovarian cancer patients. This observational study involves intravenous infusion of \[U-13C\]glucose into patients during standard paracentesis.

Cirrhosis Registry of Hospitalized Patients

Cirrhosis registry of consecutive adult consenting patients hospitalized with liver cirrhosis in the tertiary liver unit