Clinical Research Directory

Cera™ Vascular Plug System Post-Market Clinical Follow-Up

The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to: * confirm the performance * confirm the safety * identify previously unknown side-effects * monitor the identified side-effects (related to the procedures or to the medical devices) * identify and analyse emergent risks

Austrian PBC Registry

The goal of this registry is to better understand how primary biliary cholangitis develops over time, including the role of disease-related biomarkers, complications of the disease, and symptom burden. Patients with primary biliary cholangitis treated at participating centres in Austria will be invited to take part in this prospective registry. Participation in an associated biobank is optional. Clinical and laboratory data will be collected, and patients will be followed regularly through scheduled clinic visits. In addition, biological samples (serum, plasma, and, if available, liver tissue) may be collected and stored in the biobank for future research.

Treatment Outcomes for Portal Hypertension Esophageal and Gastric Varices

This study is a single-center, prospective cohort study based on real-world data. Patients with portal hypertension and esophagogastric varices were enrolled and divided into an endoscopic treatment group and a non-endoscopic treatment group (including patients receiving medical therapy, interventional procedures, or surgical treatment) according to whether they underwent endoscopic intervention. Baseline data, serum metabolites, CT imaging and endoscopic images, liver biopsy pathology, and other multi-omics data were integrated for both groups. Patients were followed up to compare adverse events after variceal treatment, including rebleeding and its causes, hepatic encephalopathy, ascites, subsequent treatments (such as regular endoscopic therapy, NSSB, and TIPS), and survival outcomes. Clinical characteristics of portal hypertension attributed to different etiologies, including hepatitis B, autoimmune liver disease, schistosomiasis, hematological disorders, and chemotherapy-induced liver injury, were compared. The efficacy and safety of endoscopic and interventional treatments for esophagogastric varices were evaluated. Factors influencing rebleeding rates among different treatment groups were analyzed, and reasons for inclusion in different groups were discussed.

Durvalumab (MEDI4736) and Tremelimumab for Hepatocellular Carcinoma in Patients Listed for a Liver Transplant

Immunotherapy can safely downstage patients and achieve durable systemic disease control to improve clinical outcomes in HCC patients undergoing liver transplant.

Ultrasound Prediction of Esophageal Variceal Bleeding Risk

This prospective observational study aims to evaluate the accuracy of using routine abdominal ultrasound to predict the risk of esophageal variceal bleeding in adult patients with liver cirrhosis. Esophageal variceal bleeding is a serious complication of chronic liver disease. While upper gastrointestinal endoscopy is the current standard for diagnosing and grading these varices, it is an invasive procedure. In this study, researchers will use ultrasound to measure the patient's spleen size and portal vein diameter. These non-invasive measurements will then be compared to the results of a standard upper endoscopy performed within 48 to 72 hours. The goal is to determine if these simple ultrasound measurements can reliably predict the presence, grade, and bleeding risk of esophageal varices, which could potentially reduce the need for routine invasive endoscopic screenings in the future.

Freiburg TIPS Registry

Patients with clinically significant portal hypertension allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Medicine II of the University Medical Center Freiburg, Germany will be offered to participate in this prospective observational trial. Clinical and laboratory as well as outcome parameters will be assessed before and within the first 12 months after TIPS implantation following a regular follow-up schedule with clinical visits at the University Medical Center Freiburg. During follow-up visits, serum/plasma samples and peripheral blood mononuclear cells (PBMC) are collected and stored in a associated biobank.

Early TIPS in Patients With Liver Cirrhosis and Ascites

The aim of this clinical trial is to compare the safety and efficacy of transjugular intrahepatic portosystemic shunt (TIPS) implantation with standard treatment (diuretic medications, and if necessary, paracenteses) in patients with liver cirrhosis and development of ascites as the first decompensating event. By creating a shunt between the liver vein and the portal vein, blood is diverted from the portal vein directly into the hepatic vein, which results in a reduction of pressure in the portal vein so that development of ascites is reduced.

Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial.

Research has proven that large varices can be treated with beta-blockers (a type of anti-hypertensive medication) to reduce the pressure in the veins. The management of small varices is still uncertain. This study aims to discover if beta blockers can be used in this setting. We hypothesize that beta blockers will reduce the risk of bleeding from small varices from 20% to 10% over a period of 3 years, resulting in significant cost savings to the NHS from better patient outcomes.

LiveSMART Trial to Prevent Falls in Patients With Cirrhosis - Supplementary Study

The LIVE-SMART supplementary study will assess social determinants of health (income, education, neighborhood deprivation), financial burden (out-of-pocket costs, productivity loss), financial distress (patient and caregiver-reported outcomes), and financial toxicity (healthcare utilization) among LIVE-SMART participants and their caregivers. Participants for this supplementary study are participants in the primary study (NCT05794555) and their caregivers.

Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation

The goal of this clinical trial is to compare the effects of somatostatin and terlipressin on lowering portal pressure in patients with portal hypertension undergoing liver transplantation, and to investigate whether there are differences in clinical outcomes between the two drugs. The study will evaluate the decrease in portal pressure from baseline following drug administration at defined time points. It will also compare the effects of these drugs on hemodynamics, bleeding, and transfusion requirements. After baseline intraoperative direct portal pressure measurement, a bolus dose of the study drug will be administered, followed by continuous intravenous infusion intraoperatively and for 24 hours postoperatively. Direct portal pressure will be measured again 5 minutes after the bolus dose, after the portal vein anastomosis, after the hepatic artery anastomosis, and, if performed after splenic artery ligation. Hemodynamic parameters will be recorded, and the drugs will be compared in terms of their intraoperative hemodynamic effects. As elevated portal pressure is associated with increased bleeding, intraoperative blood loss and transfusion needs will also be assessed between the groups. Patients will be followed for 7 days postoperatively for clinical and laboratory outcomes.

Exploration of Systemic and Portal Hemostasis in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt Placement

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.

EUS vs TJ for Liver Biopsy and Portal Pressure Gradient Measurement

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.

Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension

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.

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.

Optimizing Endoscopic and Interventional Treatment for Portal Hypertensive Bleeding

This study aims to evaluate the impact of high-risk factors-such as elevated portal venous pressure, concurrent large extra-luminal vessels, portal vein thrombosis, and prominent portosystemic shunts-on the efficacy of endoscopic therapy. By comparing with interventional treatment, the goal is to optimize the clinical management protocol for esophageal and gastric varices, enhance the therapeutic outcomes of portal hypertension-related esophageal and gastric varices, and improve patient prognosis.

Non-invasive Predictors of Esophageal Varices and Their Correlation to Upper Endoscopic Findings

The goal of this observational study: * To evaluate the diagnostic accuracy of non-invasive markers in predicting the presence and grading of esophageal varices in children with portal hypertension. * To correlate these non-invasive markers with the severity of portal hypertension and the grade of esophageal varices to identify patients at high risk of bleeding. * To propose a defined protocol for screening esophageal varices in those children.

EUS Guided Portal-systemic Pressure Gradient Measurement

Portal hypertension is characterised by an increased portal pressure gradient (PPG), that is the difference in pressure between the portal vein and the inferior vena cava (IVC). Portal hypertension is a consequence of cirrhosis resulting from chronic hepatitis. Patients with portal hypertension are at risk of developing complications including oesophageal or gastric varices, variceal bleeding, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy and mortality. Albeit its clinical significance, direct measurement of portal venous pressure to document portal hypertension has traditionally been difficult. The portal vein pressure can be measured by transhepatic or transvenous methods but the procedure carries a risk of intra-peritoneal bleeding. Furthermore, the IVC pressure measurement requires further transjugular catheterisation. Hence, the technique is rarely used. Currently, the gold standard in measurement of portal hypertension is via measurement hepatic venous pressure gradient (HVPG). The HVPG has been shown to correlate with risk of clinical decompensation, development of varices, hepatocellular carcinoma, variceal bleeding, spontaneous bacterial peritonitis and mortality. Nevertheless, the technique has a low acceptance rate amongst patients and it may not be available even in tertiary medical centres. Recently, the use of EUS-guided approach for measurement of portal pressure gradient (PPGM) has been shown to be feasible. The technical success rate was 100% and no adverse events were reported. Measurements obtained with the EUS approach was shown to correlate excellently with clinical parameters of portal hypertension including presence of varices, portal hypertensive gastropathy and thrombocytopenia. Furthermore, the procedure could be performed at the same time of screening oesophagogastroduodenoscopy (OGD), that is frequently required for variceal screening in this group of patients. Hence, the aim of the current study is to investigate the feasibility of EUS-PPGM and correlate the risk of developing complications with the PPGM in patients that are suffering from chronic hepatitis.

Fiber-Optic Navigation During TIPS Creation: A Prospective Pilot Study

Transjugular intrahepatic portosystemic shunt (TIPS) creation is an established minimally invasive treatment for complications of portal hypertension such as refractory ascites and variceal bleeding. A technically challenging step of the procedure is the puncture of the portal vein from the hepatic vein, which is usually performed under fluoroscopic guidance and may require multiple puncture attempts. This prospective pilot study evaluates the use of fiber-optic navigation technology during TIPS creation. The system allows real-time three-dimensional visualization of guidewires and catheters and may improve spatial orientation during the procedure. Approximately 30 patients with a clinical indication for TIPS placement will be included. The study will assess procedural parameters such as the number of puncture attempts, fluoroscopy time, radiation exposure, procedure duration, technical success, and complications. The results may help to improve procedural efficiency and radiation safety during TIPS interventions.

Hepatic Venous Pressure Gradient Versus Endoscopic Ultrasound-Guided Portal Pressure Gradient - Comparative Analysis (HEPCA)

The goal of this interventional trial is to compare in measuring of portal hypertension by HVPG and EUS-PPG in subject indicated to HVPG measurement. The primary question is whether EUS-PPG provides measurements really equivalent to HVPG in terms of gradient accuracy. Participants undergoing HVPG will first undergo the procedure while conscious, performed by the first operator. Immediately thereafter, HVPG will be repeated following the induction of anesthesia by a second operator blinded to the initial readings. Subsequently, EUS-PPG will be performed by an endoscopist, who will also be blinded to all previous pressure measurements.

Construction of a Portal Hypertension Biobank

Esophageal and gastric variceal bleeding (EGVB) is a severe complication of portal hypertension (PH), characterized by high bleeding volume, high rebleeding rate, and high mortality. In recent years, endoscopic treatment has significantly improved therapeutic efficacy and patient survival. However, due to substantial individual variations among patients, individualized stratified management is crucial. For special populations with cirrhotic portal hypertension, clear management guidelines and clinical research evidence are lacking. The incidence of non-cirrhotic portal hypertension is increasing year by year; it has complex etiologies, lacks specific symptoms and imaging features, and poses diagnostic challenges. Currently, multi-omics research on portal hypertension is insufficient. The integration of multi-omics technologies, including genomics, radiomics, metabolomics, and gut microbiota, holds promise for a more comprehensive understanding of the pathogenesis. With continuous improvements in multi-modal medical data fusion technology, there is an urgent need to develop clinical decision support systems by combining standardized multi-omics databases with artificial intelligence techniques, thereby enhancing clinical decision-making capabilities and prognostic assessment. This study aims to expand the established portal hypertension biobank by extending the temporal depth of clinical cohort data and diversifying sample types.

Cirrhotic and Non-cirrhotic Patients With Clinically Significant Portal Hypertension

Alterations in conventional coagulation tests in patients with cirrhosis and/or portal hypertension do not reliably predict bleeding risk, as hemostatic balance is complex and often compensated. Many procedure-related bleeding events are driven by non-coagulatory factors, such as portal hypertension or technical aspects of the procedure. Most commonly performed procedures carry a low risk of bleeding even in the presence of elevated INR or thrombocytopenia, and no validated laboratory thresholds support prophylactic correction. Risk assessment should therefore be based on procedural factors, severity of liver disease, and systemic patient conditions, with correction of modifiable risk factors particularly before high-risk elective procedures.

3D-MRE for Assessing Cirrhosis, Advanced Chronic Liver Disease and Portal Hypertension

How to construct a novel, non-invasive, accurate, and convenient method to achieve prediction of hepatic venous pressure gradient (HVPG) is an important general problem in the management of portal hypertension in cirrhosis or advanced chronic liver disease. We plan to investigate the ability of three demensional-magnetic resonance elastography (3D-MRE) to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis or advanced chronic liver disease.

Liver Cirrhosis Complicated by Clinically Significant Portal Hypertension

Portal hypertension is a major complication of cirrhosis. HVPG is the diagnostic gold standard but is invasive. Non-invasive tools such as spleen stiffness measurement (SSM) and CEUS show promise for assessing CSPH, though they have not yet been compared directly. A multimodal ultrasound approach may provide a reliable alternative to HVPG.

The Feasibility, Safety, and Efficacy of EUS-Guided PSE: A Cohort Study

Bleeding from esophagogastric varices in patients with liver cirrhosis is often life-threatening. Thrombocytopenia caused by hypersplenism secondary to portal hypertension is an independent risk factor for such gastrointestinal bleeding. Studies have confirmed that partial splenic embolization (PSE) can effectively reduce portal pressure and decrease the risk of rebleeding. Traditional treatments mainly include total splenectomy and X-ray-guided transarterial partial splenic embolization (X-PSE). Although total splenectomy can completely remove the lesion, its application is limited by issues such as increased risks of postoperative infection, thrombosis, and long-term immune dysfunction. Currently, X-PSE has become the mainstream treatment. This technique involves superselective catheterization of the splenic artery branches using a microcatheter and injecting embolic microspheres to achieve partial splenic embolization, thereby preserving partial splenic function. However, X-PSE relies on radiological intervention techniques and carries risks such as radiation exposure, contrast-induced nephropathy, and non-target embolization (e.g., pancreatic necrosis). Additionally, its ability to locate small arterial branches in the splenic hilum is limited. Endoscopic ultrasound (EUS) integrates an ultrasound probe at the tip of an endoscope, enabling high-resolution imaging and fine-needle aspiration therapy of the pancreas, gastrointestinal tract, posterior mediastinum, and retroperitoneal structures. With color Doppler functionality, EUS can clearly identify abdominal vessels and their blood flow signals. Since the spleen and splenic vessels are located posterior to the gastric fundus, EUS can clearly visualize the vascular structures of the splenic hilum via a transgastric approach. Compared to X-PSE, EUS-guided PSE offers the following advantages: a shorter puncture path; avoidance of iodinated contrast agents, making it suitable for patients with iodine allergies or renal insufficiency; no X-ray exposure for patients or operators; the ability to combine treatment for esophagogastric varices in the same procedure, thereby simplifying the process, reducing costs, and shortening hospital stays; and, since there is no arterial puncture site on the body surface, patients do not require prolonged limb immobilization postoperatively, resulting in an overall better healthcare experience. Current literature and small-sample retrospective studies have reported on this technique, but the included cases are mostly limited to patients with mild liver function impairment, and there is a lack of systematic evaluation of its effect on portal pressure reduction. The investigators' center integrates the advantages of EUS and X-PSE to perform EUS-guided transgastric puncture for precise injection of embolic materials into the splenic artery branches in patients with liver cirrhosis, gastrointestinal bleeding, and hypersplenism, achieving partial splenic embolization. This study aims to evaluate the safety and efficacy of EUS-guided PSE. The primary endpoint is safety, including the incidence of complications such as intraoperative bleeding, postoperative fever, and abdominal pain scores. Secondary endpoints include efficacy indicators: platelet count, portal pressure gradient, embolization area on CT, incidence of gastrointestinal rebleeding, as well as hospitalization costs and length of stay.