[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"portal-hypertension-related-to-cirrhosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:portal-hypertension-related-to-cirrhosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,47,78,113,134,164,192,228,257,282,306,326,350,371,398,422],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100555523","eus-guided-response-assessment-to-nsbb-100555523",false,"NCT06513195","EUS-guided Response Assessment to NSBB","Endoscopic Ultrasound Guided Response Assessment to Non-selective Beta-blockers in the Treatment of Clinically Significant Portal Hypertension","Inclusion Criteria:\n\n* Patients with a clinical and\u002For pathological diagnosis of compensated cirrhosis.\n* Patients with suspicion of CSPH and thus indication for NSBB treatment.\n* Patients not yet on NSBB therapy.\n* Patients willing and able to undergo repeated HVPG and EUS-guided pressure measurements as per protocol.\n\nExclusion Criteria:\n\nGeneral criteria\n\n* Patient is \\\u003C18 or \\>80 years of age\n* Patient is pregnant, breast-feeding or planning to become pregnant during the course of the study\n* Patient is unwilling or unable to sign the informed consent\n* Patients in whom general anesthesia or endoscopic procedures are contraindicated Medical criteria\n* Patients with cirrhosis and HCC Portopulmonary hypertension Portal or splanchnic venous thrombosis Prior TIPS Prior liver transplantation\n* Non-cirrhotic portal hypertension or pre-sinusoidal liver disease\n* Cholestatic liver disease with total bilirubin \\>3 mg\u002Fdl\n* Previous total or partial splenectomy\n* Known infection that is not controlled by medical intervention\n* Patients with contraindications for non-selective beta-blocker therapy, including but not limited to the following baseline vital signs:\n\nSystolic BP \\\u003C100 mmHg HR \\\u003C50 bpm\n\n* Patients with reduced life expectancy described by an ASA score of 4 or 5\n* INR \\>1.7 or platelet count \\\u003C50.000 per mm3\n* eGFR \\\u003C50 ml\u002Fmin\u002F1.73m2 (CKD-EPI formula) Anatomical criteria\n* Anatomical abnormalities that prevent access via EUS-guided puncture to the hepatic vein or intrahepatic portion of the portal vein, including anatomy that predisposes to difficult to reach puncture sites or an inadequate needle angle.\n* Visualization of ascites interposing the puncture tract on EUS\n* Diagnosis of portal vein thrombosis during EUS\n* Evidence of active gastrointestinal bleeding during EUS","ALL","18 Years","80 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if endoscopic ultrasound (EUS)-guided portal pressure measurement can determine the treatment response to non-selective beta-blockers (NSBB) in patients with cirrhosis and clinically significant portal hypertension (CSPH). Participants will undergo EUS-guided portal pressure measurement before start of Carvedilol en after three months of treatment. EUS-guided measurements will be paired with transjugular hepatic venous pressure gradient (HVPG) measurement as well as non-invasive tests for assessment of portal hypertension.",[27],"Portal Hypertension Related to Cirrhosis",[29,30,31,32,33],"portal hypertension","EUS-PPG","HVPG","cirrhosis","non-selective beta blockers","RECRUITING","2026-06-02",{"date":37,"type":38},"2026-06-03","ACTUAL",{"date":40,"type":38},"2024-07-17",{"date":42,"type":21},"2026-12",{"name":44,"class":45},"Universitaire Ziekenhuizen KU Leuven","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100614499","microplastics-cirrhosis-and-portal-hypertension-100614499","NCT07280390","Microplastics, Cirrhosis and Portal Hypertension","The Impact of Microplastics and Nanoplastics on Liver Health and Cardiovascular Diseases in India","Inclusion Criteria:\n\n* Age range of 18-70 years\n* Cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings.\n* Undergoing elective surgery or liver transplantation\n\nExclusion Criteria:\n\n* • Hepatocellular carcinoma\n\n  * Pregnancy or lactation\n  * Patients with HIV or retroviral therapy\n  * Prior liver interventions like locoregional therapy, presence of HCC, prior abdominal surgery","70 Years",{"count":56,"type":21},30,"OBSERVATIONAL","Cirrhosis and portal hypertension are associated with an hyperdynamic circulation and hepatic inflammation, leading to complications like ascites, variceal bleeding, acute kidney injury, and higher infection risk. Microplastics (MPs) are a global plastic pollution issue, and studies have found plastic MPs or nanoparticles (NPs) contaminating human, animal and environmental ecosystems.It has been noted that the accumulation of MPs increases with a reduction in size of the plastic particle. MPs are categorized into primary particles such as manufactured plastics including pellets and cosmetic microbeads and secondary particles which originate from mechanical and ultraviolet disruption of large plastic particles. MPs can be ingested via food or beverages, especially plastic packaged comestibles or inhaled as environmental pollutants. Contamination of medications such as antibiotics, intravenous fluids, albumin and medical devices is another source of exposure to microplastics in patients with chronic liver disease (CLD)In particular exposure to endoscopic interventions, liver biopsy, and invasive procedures such as paracentesis and interventional radiology procedures can lead to plastic exposure and deposition of MPs in the liver and other tissues in patients with cirrhosis. It may be hypothesized that these may contribute to hepatic inflammation and progression of cirrhosis and portal hypertension.\n\nGlobally, there is new research on the influence of MPs on the environment, plant and animal ecosystems and human health.\n\nPolystyrene (PS) microspheres that concentrate in the liver, intestine and the kidneys of mammals disrupt lipid and energy metabolism, impair mucus secretion, and alter the microbiome. Therefore, studies are required to assess how and to what extent, MPs impact human health, and affect chronic diseases like cirrhosis and reduce longevity.\n\nThe study investigators will assess the presence of MPs in the liver, kidneys and intestine of patients with liver cirrhosis and compare it with those without underlying liver disease and determine the impact on portal hypertension and fibrosis, and cardiovascular and metabolic function.",[60,61,27,62,63,64],"Cirrhosis","Microplastics","Nanoplastics","Pollution","Cirrhosis and Chronic Liver Disease",[61,62,66,60,67],"Plastic pollution","Portal hypertension","2026-05-13",{"date":70,"type":38},"2026-05-15",{"date":72,"type":38},"2026-05-01",{"date":74,"type":21},"2027-02-25",{"name":76,"class":45},"Post Graduate Institute of Medical Education and Research, Chandigarh",2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":96,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":46},"100630837","multiparametric-ultrasound-for-the-noninvasive-diagnosis-of-porto-sinusoidal-vascular-liver-disorder-100630837","NCT07492862","Multiparametric Ultrasound for the Noninvasive Diagnosis of Porto-sinusoidal Vascular Liver Disorder","Explorative Study for the Application of Dynamic Contrast-enhanced Ultrasound for the Noninvasive Diagnosis of Porto-sinusoidal Vascular Liver Disorder","CEUS-PSVD","Inclusion criteria - PSVD group\n\n* Histologically confirmed diagnosis of porto-sinusoidal vascular disease (PSVD);\n* Presence of clinically significant portal hypertension, evidenced by at least one specific sign of portal hypertension (e.g., imaging evidence of collateral circulation or porto-systemic shunts, endoscopic evidence of esophageal or gastric varices, or history of gastrointestinal variceal bleeding);\n* Age ≥ 18 years;\n* Ability to understand the study information and provide written informed consent;\n\nInclusion criteria - Cirrhosis group\n\n* Diagnosis of liver cirrhosis confirmed by liver histology or, alternatively, by compatible findings on imaging, laboratory tests, and physical examination together with a positive history for at least one known cause of chronic liver disease;\n* Presence of clinically significant portal hypertension, evidenced by at least one specific sign of portal hypertension (e.g., imaging evidence of collateral circulation or porto-systemic shunts, endoscopic evidence of esophageal or gastric varices, or history of gastrointestinal variceal bleeding);\n* Age ≥ 18 years;\n* Ability to understand the study information and provide written informed consent.\n\nExclusion criteria - PSVD group (cases)\n\n* Presence of other causes of portal hypertension, including but not limited to: history of bone marrow transplantation, Budd-Chiari syndrome or hepatic venous outflow obstruction, hepatic schistosomiasis, Abernethy malformation, hereditary hemorrhagic telangiectasia, sarcoidosis, congenital hepatic fibrosis, or chronic cholestatic liver diseases;\n* Presence of portal, spleno-mesenteric, or hepatic vein thrombosis;\n* Prior hepatic or splenic surgery;\n* Presence of primary or secondary malignant liver tumors;\n* Presence of a transjugular intrahepatic portosystemic shunt (TIPS) device;\n* Congenital anomalies of the liver or biliary tract;\n* History of heart failure;\n* Contraindications to administration of SonoVue (sulfur hexafluoride microbubbles), including: prior allergic reaction to the active substance or any excipients, known right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \\> 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome;\n* Inadequate sonographic visualization of the right hepatic lobe;\n* Pregnancy.\n\nExclusion criteria - Cirrhosis group\n\n* Decompensated cirrhosis or Child-Pugh class C;\n* Cryptogenic cirrhosis;\n* Presence of other causes of portal hypertension (same list as for PSVD exclusions: history of bone marrow transplantation, Budd-Chiari syndrome or hepatic venous outflow obstruction, hepatic schistosomiasis, Abernethy malformation, hereditary hemorrhagic telangiectasia, sarcoidosis, congenital hepatic fibrosis, chronic cholestatic diseases);\n* Presence of portal, spleno-mesenteric, or hepatic vein thrombosis;\n* Prior hepatic or splenic surgery;\n* Presence of primary or secondary malignant liver tumors;\n* Presence of a transjugular intrahepatic portosystemic shunt (TIPS) device;\n* Congenital anomalies of the liver or biliary tract;\n* History of heart failure;\n* Contraindications to administration of SonoVue (sulfur hexafluoride microbubbles), including: prior allergic reaction to the active substance or any excipients, known right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \\> 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome;\n* Inadequate sonographic visualization of the right hepatic lobe;\n* Pregnancy.",{"count":87,"type":21},100,[24],"Porto-sinusoidal vascular disease (PSVD) is a rare clinical entity characterized by significant portal hypertension in the absence of cirrhosis on liver histology, which may or may not show specific alterations of the portal vein, sinusoids, or hepatic lobular architecture. Currently, diagnosis of this condition necessarily requires a liver biopsy and, despite some differences detected on imaging studies-and particularly on liver and spleen elastography-PSVD remains indistinguishable from cirrhosis using non-invasive tests.\n\nContrast-enhanced ultrasound (CEUS) is an easy-to-perform, repeatable, and cost-effective examination that enables real-time assessment of parenchymal or focal liver lesion perfusion. Moreover, the application of dynamic contrast-enhanced ultrasound (DCE-US-i.e., contrast-enhanced ultrasound followed by quantitative perfusion analysis using dedicated software, such as the VueBox Software that will be used in this study) allows integration of CEUS qualitative assessment with quantitative evaluation of tissue perfusion through analysis of time-intensity curves generated during contrast transit. From this analysis, several perfusion-related parameters can be derived (for example, peak enhancement, time to peak, or area under the curve), which have already proven useful in improving differential diagnosis of focal liver lesions and in predicting treatment response and systemic therapy outcomes.\n\nTo date, the use of DCE-US for the diagnosis of PSVD has not yet been described; however, based on the underlying histological alterations associated with this disease, it is reasonable to hypothesize that parameters obtained with this technique in the liver parenchyma of patients with PSVD may differ from those measured in patients with liver cirrhosis. The aim of the present project is to apply DCE-US in patients with PSVD and in patients with cirrhosis to evaluate potential significant differences in perfusion parameters, and to assess the feasibility of a non-invasive differential diagnosis between the two conditions using this technique in combination with elastography and bidimensional ultrasound data to develop a multiparametric diagnostic score.",[91,92,93,27,94,95],"Porto-sinusoidal Vascular Liver Disorder","Liver Cirrhosis","Portal Hypertension, Noncirrhotic","Ultrasound Elastography","Contrast-enhanced Ultrasound",[97,98,99,100,101,102],"porto-sinusoidal vascular liver disorder","liver cirrhosis","liver ultrasound","ultrasound elastography","dynamic contrast-enhanced ultrasound","chronic liver disease","NOT_YET_RECRUITING","2026-03-20",{"date":106,"type":38},"2026-03-25",{"date":108,"type":21},"2026-03",{"date":110,"type":21},"2028-12",{"name":112,"class":45},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":120,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":46},"100629338","indicators-affecting-pvt-recanalization-100629338","NCT07473375","Indicators Affecting PVT Recanalization","Indicators Affecting Portal Vein Thrombosis Recanalization in Cirrhosis With Gastroesophageal Varices","Inclusion Criteria:\n\n* diagnosed as cirrhosis and confirmed gastroesophageal varices by endoscopy;\n\n  * all patients were diagnosed as PVT by CTA at admission.\n\nExclusion Criteria:\n\n* patients with hepatocellular carcinoma;\n\n  * patients with extrahepatic malignancies;\n\n    * history of liver transplantation or TIPS;\n\n      * lack of information regarding anticoagulation therapy；\n\n        * those with cavernous transformation of the portal vein(CTPV) .",{"count":121,"type":21},1500,"This is a retrospective-prospective study conducted at Zhongshan Hospital, Fudan University, to explore portal vein thrombosis (PVT) in patients with cirrhosis and gastroesophageal varices (GEV). It aimed to provide insights into the diagnosis, follow-up, and factors influencing PVT recanalization, to help patients, families, and healthcare providers understand the disease and related clinical management.",[124,60,27,93],"Portal Vein Thrombosis","2026-03-13",{"date":127,"type":38},"2026-03-16",{"date":129,"type":38},"2017-01-01",{"date":131,"type":21},"2028-12-31",{"name":133,"class":45},"Shanghai Zhongshan Hospital",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":143,"conditions":144,"keywords":147,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":4},"100627593","hepatic-and-splenic-microcirculatory-perfusion-for-ruling-out-high-risk-varices-in-patients-with-hepatitis-b-related-cirrhosis-100627593","NCT07450651","Hepatic and Splenic Microcirculatory Perfusion for Ruling Out High-Risk Varices in Patients With Hepatitis B-Related Cirrhosis","Development of a Hepato-Splenic Microcirculatory Perfusion Model Using IVIM MRI to Rule Out High-Risk Varices in Patients With Compensated Hepatitis B-Related Cirrhosis","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Clinically diagnosed with chronic hepatitis B cirrhosis\n3. Acceptance of upper gastrointestinal endoscopy screening or evaluation.\n4. Abdominal MRI examination with IVIM sequence within 6 months prior to endoscopy.\n\nExclusion Criteria:\n\n1. Co-existing chronic liver diseases.\n2. Previous portosystemic shunt treatment or splenectomy.\n3. A history of treatment for upper gastrointestinal varices that affects the assessment.\n4. Severe hepatic or splenic iron deposition.\n5. Decompensated cirrhosis.\n6. Co-existing malignancies.",{"count":142,"type":21},150,"Background:\n\nChronic hepatitis B (CHB)-related cirrhosis is a common cause of portal hypertension, which leads to the development of gastroesophageal varices (EGVs). High-risk varices (HRV) are associated with a higher risk of bleeding and require timely interventions. Endoscopy is the gold standard for diagnosing HRV but is invasive and not suitable for routine screening in large populations.\n\nObjective:\n\nThis study aims to develop a noninvasive model based on hepatic and splenic microcirculatory perfusion parameters derived from intravoxel incoherent motion (IVIM) magnetic resonance imaging (MRI) to predict and rule out HRV in patients with compensated CHB-related cirrhosis receiving antiviral therapy.\n\nMethods:\n\nThis observational, retrospective study will include patients with compensated CHB-related cirrhosis who have undergone both esophagogastroduodenoscopy (EGD) and IVIM MRI. Microcirculatory perfusion parameters will be extracted from IVIM images using a biexponential model, and their ability to predict HRV will be assessed.\n\nOutcomes:\n\nThe study will validate the performance of the Hepato-Splenic Microcirculatory Perfusion Model (HSMP) in ruling out HRV compared to conventional noninvasive tests like APRI, FIB-4, and LSM. The model's diagnostic accuracy will be evaluated with a focus on reducing unnecessary endoscopic procedures.\n\nSignificance:\n\nIf successful, this model could reduce the need for invasive endoscopy and improve the management of cirrhosis patients by providing a safer and more accessible screening tool for HRV.",[145,27,146],"Hepatitis B Virus Related Cirrhosis","Esophagogastric Varices",[148,149,150,151,152,153,154],"Intravoxel incoherent motion","Hepatic microcirculation","Splenic microcirculation","High-risk varices","Baveno VI criteria","FIB-4","Liver stiffness measurement","2026-03-01",{"date":157,"type":38},"2026-03-05",{"date":159,"type":21},"2026-02",{"date":161,"type":21},"2026-10",{"name":163,"class":45},"Beijing Friendship Hospital",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":173,"studyType":57,"phases":4,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":4},"100622955","viatorr-tips-study-evaluating-6-10mm-diameters-viatips-100622955","NCT07390344","VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)","VIATIPS","Inclusion Criteria:\n\n1. The subject is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for de novo TIPS creation.\n2. The subject has cirrhotic portal hypertension.\n3. The subject is ≥18 years of age.\n4. The subject is capable of complying with protocol requirements, including follow up.\n5. The subject or legal representative signed the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis.\n2. The subject has received a liver transplantation. Patients on the transplant list are still eligible.\n3. The subject has a life expectancy of less than 6 months.\n4. The subject has extrahepatic or hepatic malignancy or a history of previous malignancy, unless treated curatively ≥5 years prior to enrollment. Subjects with non-melanoma skin cancer and\u002For carcinoma in situ of the cervix remain eligible.\n5. The subject has inadequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of \\> 25 or Child Pugh Score of \\> 14.\n6. The subject is enrolled in another investigational study, unless agreed in advance in writing by the Sponsor.\n7. The subject is pregnant at the time of informed consent signature.\n8. The subject has any other condition which in the judgement of the investigator would preclude adequate Study participation.",{"count":172,"type":21},152,"2 Years","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.\n\nAdditionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.",[176,177,27],"Ascites","Variceal Bleeding",[29,179,32,180,181],"TIPS","decompensated","Transjugular Intrahepatic Portosystemic Shunt","2026-02-05",{"date":184,"type":38},"2026-02-10",{"date":186,"type":21},"2026-06",{"date":188,"type":21},"2029-09-30",{"name":190,"class":191},"W.L.Gore & Associates","INDUSTRY",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":204,"conditions":205,"keywords":208,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":46},"100597412","phase-4-optimizing-portal-hypertension-with-tips-and-interval-metabolic-surgery-for-advanced-liver-disease-100597412","NCT07058155","Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease","OPTIMAL Trial: Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease","OPTIMAL","Inclusion Criteria\n\n1. Candidate for general anesthesia.\n2. Age 18-70 years at consent.\n3. BMI 35-70 kg\u002Fm² at first study visit.\n4. Eligible for sleeve gastrectomy per ASMBS\u002FIFSO 2022 guidelines.\n5. Insurance coverage for metabolic surgery.\n6. Current or prior anti-obesity medication use permitted.\n7. Liver cirrhosis confirmed by biopsy or non-invasive assessment.\n8. Clinically significant portal hypertension (HVPG ≥ 10 mm Hg, or esophagogastric varices \u002F portal-hypertensive gastropathy, or imaging evidence of collaterals\u002Fdilated portal vein).\n9. Able and willing to provide informed consent and comply with study procedures.\n10. Women of child-bearing potential: negative urine pregnancy test at screening and randomization and agreement to reliable contraception for 2 years.\n\nExclusion Criteria\n\n1. Prior bariatric\u002Fmetabolic surgery (except removed devices ≥ 3 months earlier).\n2. Prior complex foregut surgery.\n3. History of solid-organ transplant.\n4. Severe pulmonary disease (FEV1 \\\u003C 50 % predicted).\n5. Significant cardiac or atherosclerotic disease with planned re-vascularization within 12 months.\n6. ASA class IV or V uncompensated cardiopulmonary disease.\n7. Left-ventricular ejection fraction \\\u003C 25 % or MI\u002Funstable angina\u002Fstroke\u002Fheart surgery\u002Fcoronary stent within 6 months.\n8. Hiatal hernia \\> 7 cm or LA grade C\u002FD erosive esophagitis.\n9. Active Crohn's disease.\n10. Severe psychiatric illness, dementia, active psychosis, history of suicide attempt, or alcohol\u002Fsubstance abuse within 12 months.\n11. Pregnant, breastfeeding, planning pregnancy, or not using adequate contraception.\n12. Malignancy within the prior 12 months (except non-melanoma skin cancer).\n13. Life expectancy \\\u003C 2 years in investigator's judgment.\n14. Investigational therapy within 3 months.\n15. Acute pancreatitis ≤ 90 days.\n16. Portal vein thrombosis at screening.\n17. Decompensated cirrhosis (moderate\u002Flarge ascites, hepatic encephalopathy, or listed for liver transplant); small ascites or prior variceal bleed allowed.\n18. Total bilirubin \\> 3 mg\u002FdL, INR \\> 1.7, or platelets \\\u003C 50 000\u002FµL (within 1 month).\n19. Significant alcohol intake (\\> 14 units\u002Fweek women, \\> 21 units\u002Fweek men) within the prior 12 months.\n20. eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m² or on dialysis (within 1 month).\n21. AIDS.\n22. Unable to understand study or give consent.\n23. Plans to move more than 3 hours from Cleveland within 6 months.\n24. Previous randomization in this trial.\n25. Any condition that, in the investigator's opinion, places the subject at undue risk.",{"count":201,"type":21},70,[203],"PHASE4","Cirrhosis is a form of advanced liver disease that can lead to serious complications, especially when combined with severe obesity. Many patients with cirrhosis also develop a condition called clinically significant portal hypertension (CSPH), which is increased pressure in the veins of the liver. CSPH raises the risk of life-threatening events like internal bleeding and liver failure. Unfortunately, treatment options for people who have both cirrhosis and severe obesity are very limited, especially when portal hypertension is present.\n\nThis study, called the OPTIMAL Trial, is a randomized clinical trial designed to evaluate whether combining two procedures improves health outcomes in this high-risk population. The first procedure, called TIPS (Transjugular Intrahepatic Portosystemic Shunt), is a minimally invasive treatment that reduces pressure in the liver by creating a pathway for blood to flow more easily. The second procedure is sleeve gastrectomy, a form of metabolic (bariatric) surgery that helps patients lose weight and improve related conditions like diabetes.\n\nThe study will compare two groups:\n\n1. One group will receive TIPS followed by sleeve gastrectomy (TIPS+SG).\n2. The other group will receive medical weight management (standard non-surgical care, including diet, lifestyle changes, and weight loss medications).\n\nAll participants will have severe obesity and cirrhosis with CSPH but will not have decompensated liver disease (such as large amounts of fluid in the abdomen, a history of variceal bleeding, or recent liver failure). Eligible participants will be randomly assigned to one of the two groups.\n\nThe main goal of the study is to determine whether the combination of TIPS + SG improves quality of life and leads to greater weight loss compared to medical therapy alone. The study will also monitor for any complications from either the procedures or the medical treatment.\n\nParticipants will be followed for 6 months after their treatment starts, with periodic assessments of their physical health, liver function, and overall well-being. Some participants may also be followed for a longer period to assess long-term outcomes.\n\nThis study hopes to provide high-quality evidence for a novel, stepwise treatment strategy that may help people with obesity and liver disease live longer, healthier lives. If successful, it could change how advanced liver disease and obesity are managed together, especially in patients who currently have few safe and effective options. All study care is provided at Cleveland Clinic, Cleveland, Ohio, USA.",[206,27,207,179],"Liver Cirrhoses","Severe Obesity",[209,210,211,212,213,214,215,216,217,218],"Sleeve Gastrectomy","Transjugular Intrahepatic Portosystemic Shunt (TIPS)","Bariatric Surgery \u002F Metabolic Surgery","Clinically Significant Portal Hypertension (CSPH)","Health-Related Quality of Life (HRQOL)","SF-36 Questionnaire","Weight Loss","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Randomized Controlled Trial","2025-12-20",{"date":221,"type":38},"2025-12-23",{"date":223,"type":38},"2025-12-17",{"date":225,"type":21},"2034-02-01",{"name":227,"class":45},"The Cleveland Clinic",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":237,"conditions":238,"keywords":243,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":252,"leadSponsor":254,"locationsCount":46},"100615325","a-comparative-study-of-mri-and-ultrasound-for-detection-of-primary-hepatocellular-carcinoma-body-composition-and-risk-factors-for-decompensation-in-liver-cirrhosis-100615325","NCT07291141","A Comparative Study of MRI and Ultrasound for Detection of Primary Hepatocellular Carcinoma, Body Composition and Risk Factors for Decompensation in Liver Cirrhosis","DETECT-HCC","Inclusion Criteria:\n\n* Patients with liver cirrhosis, according to clinical practice. Based on criteria such as elastography, symptoms, biopsy, or radiology.\n* Age ≥18 years ≤ 84\n* Written informed consent from the participant\n\nExclusion Criteria:\n\n* Contraindications for MRI (ferrrous material, claustrophobia)\n* Pregnancy\n* Diagnosis of primary sclerosing cholangitis (PSC)\n* Vascular liver disease\n* Congenital liver fibrosis\n* Previous diagnosis of hepatic carcinoma (HCC)\n* Previous liver transplant",{"count":236,"type":21},600,"DETECT-HCC-ESLD is a prospective multicenter study designed to examine early detection and risk stratification of hepatocellular carcinoma (HCC) in individuals with advanced liver disease. Adults with cirrhosis of different etiologies are enrolled and followed longitudinally with structured clinical assessments and imaging at predefined intervals.\n\nA key objective is to evaluate ultrasound and abbreviated MRI (AMRI) as surveillance modalities for HCC. The study examines detection performance, feasibility, and factors influencing image quality and interpretability.\n\nThe protocol also includes the study of body composition, focusing on how variations in adiposity and muscle mass may relate to imaging characteristics, disease progression, and HCC risk.\n\nLongitudinal clinical and imaging data are used to explore prediction models aimed at identifying patients with differing levels of HCC risk. The study records outcomes such as incident HCC, liver-related complications, and mortality to support analyses of disease trajectories.\n\nThe DETECT-HCC-ESLD study provides a structured framework for collecting clinical, imaging, and body composition data over time, enabling detailed evaluation of surveillance strategies and risk patterns in advanced liver disease.",[206,239,240,27,241,242],"Hepatocellular Carcinoma (HCC)","Sarcopenia in Liver Cirrhosis","MRI","Ultrasound",[244,245,246,247],"Abbreviated MRI","Hepatocellular carcinoma","Liver cirrhosis","Sarcopenia","2025-12-18",{"date":250,"type":38},"2025-12-19",{"date":248,"type":38},{"date":253,"type":21},"2031-12",{"name":255,"class":256},"Mattias Ekstedt","OTHER_GOV",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":271,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":46},"100567562","effectiveness-and-safety-of-tips-stent-graft-in-the-treatment-of-cirrhosis-and-complications-of-portal-hypertension-100567562","NCT06669806","Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension","A Prospective, Multi-Center, Single-Arm Clinical Study to Evaluate the Effectiveness and Safety of LIVERTYTM TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension","Inclusion Criteria:\n\n1. The subject who is 18 years old or above but 75 years old or below;\n2. The subject who is diagnosed with portal hypertension caused by liver cirrhosis with the history of gastrointestinal variceal bleeding or bleeding, hepatic hydrothorax, and refractory or recurrent ascites;\n3. The subject must have adequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of ≤13 or Child-Pugh Score of ≤18;\n4. The subject with platelet count≥ 20×10\\^9 \u002FL;\n5. Subjects or their guardians who can understand the content of the clinical trial, voluntarily participate in the clinical trial and sign the ICF and can complete the follow-up period according to the requirements of the clinical trial.\n\nExclusion Criteria:\n\n1. The subject who is pregnant or lactating or plan to get pregnant during the clinical trial;\n2. According to the judgment of investigator, the subject with main portal vein thrombosis which thrombus occupying \\>50% of the portal vein lumen and affecting postoperative hemodynamics;\n3. The subject who has received surgical or interventional treatment (such as TIPS, surgical shunt and retrograde transvenous obliteration (-RTO) for treatment of complications from portal hypertension. Note: The subject who have received -RTO for variceal bleeding at least 8 weeks before signing the informed consent form can be included in the clinical trial;\n4. The subject who needs to receive or have received splenectomy;\n5. The subject who has received or plan to receive liver transplantation;\n6. The subject who cannot have a shunt channel established in the liver parenchyma between the hepatic vein and the portal vein as determined by the investigators;\n7. The subject with extrahepatic or hepatic malignancies;\n8. The subject with Budd-Chiari syndrome and hepatic sinusoidal obstruction syndrome;\n9. The subject with congenital cystic dilatation of bile duct (Caroli disease) and obstructive dilation of biliary tract;\n10. The subject with polycystic liver disease;\n11. The subject with cavernous transformation of the portal vein;\n12. The subject with severe or refractory hepatic encephalopathy (Grade 2 or above according to the West Haven Criteria);\n13. The subject with a TBIL level higher than 51.3 μmol\u002FL (excluding the Patients with cholestatic cirrhosis);\n14. The subject with coagulation disorders (INR: \\>2.5);\n15. The subject with a systolic pressure lower than 80 mmHg;\n16. The subject with severe tricuspid regurgitation or congestive heart failure;\n17. The subject with myocardial infarction within the past 3 months;\n18. The subject with moderate to severe pulmonary arterial hypertension, or severe hepatopulmonary syndrome;\n19. The subject with uncontrolled systemic infection or inflammation;\n20. The subject with severe renal insufficiency (Scr level:\\>199.5 μmol\u002FL) or needing to receive dialysis;\n21. The subject known to be allergic to the contrast media or to the constituent materials of the TIPS covered segment;\n22. The subject with the history of epilepsy or mental illness or with cognitive impairment;\n23. The subject with the expected survival time of less than 1 year;\n24. The subject who is otherwise determined as ineligible for participation in this Study by investigators;\n25. The subject who is participating in any other unfinished drug or medical device clinical trials.","75 Years",{"count":266,"type":21},166,[24],"This Study is a prospective, multi-center, single-arm objective perform an criteria (OPC) study. A 12 months follow-up study on the patients who intend to receive the treatment of cirrhosis and complications of portal hypertension with the TIPS Stent Graft will be conducted. The primary evaluation endpoint of this Study is the stent patency at 6 months after treatment completion .",[27,270,177],"Ascites Hepatic",[272,273,274],"Transjugular intrahepatic portosystemic shunt","TIPS stent","patency",{"date":250,"type":38},{"date":277,"type":38},"2024-11-21",{"date":279,"type":21},"2027-01-01",{"name":281,"class":191},"C. R. Bard",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":46},"100614611","tips-with-or-without-bcaa-100614611","NCT07281846","TIPS With or Without BCAA","Transjugular Intrahepatic Portosystemic Shunt With or Without Branched-Chain Amino Acid Supplements in the Treatment of Patients With Cirrhotic Portal Hypertension Complicated by Sarcopenia: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age between 18 and 80 years old;\n2. Diagnosed with cirrhosis complicated by sarcopenia;\n3. Patients admitted due to variceal bleeding or refractory ascites who meet the indications for transjugular intrahepatic portosystemic shunt (TIPS).\n\nExclusion Criteria:\n\n1. Hepatocellular carcinoma and\u002For other malignant tumors;\n2. Severe cardiopulmonary insufficiency;\n3. Child-Pugh score \\> 13 points;\n4. Spontaneous recurrent hepatic encephalopathy (HE);\n5. Large spontaneous portosystemic shunt;\n6. Sepsis; spontaneous bacterial peritonitis (SBP);\n7. Allergy to any component of the study nutritional supplement;\n8. High-energy and high-protein diet or use of calcium supplements, vitamin D supplements, or protein\u002Famino acid supplements within 3 months prior to the study.",{"count":290,"type":21},164,[24],"Cirrhosis is a major global cause of morbidity and mortality in chronic liver disease patients, accounting for 2.4% of global deaths in 2019. A 1990-2017 Global Burden of Disease study showed rising cirrhosis-related deaths, bringing heavy health and economic burdens. It often leads to portal hypertension and subsequent complications like ascites, gastroesophageal variceal bleeding (20% 6-week mortality), and hepatic encephalopathy (HE). Transjugular intrahepatic portosystemic shunt (TIPS) is an important treatment for variceal bleeding and refractory ascites per guidelines from EASL, AASLD, and the Chinese Medical Association.\n\nMalnutrition affects 20% of compensated and over 50% of decompensated cirrhotic patients; sarcopenia (severe malnutrition) is linked to higher cirrhosis-related complications, impaired quality of life, survival, and poor prognosis in TIPS-treated patients. Thus, concurrent sarcopenia intervention during TIPS may improve outcomes.\n\nBaveno VII, EASL, and AASLD guidelines recommend branched-chain amino acid (BCAA) and leucine-rich supplements for decompensated cirrhosis to ensure adequate nitrogen intake. RCT evidence shows BCAAs improve skeletal muscle index (SMI) in cirrhotic patients with sarcopenia and reduce HE risk, but evidence for TIPS-treated patients is lacking. This study aims to compare muscle mass changes and clinical prognosis between TIPS patients with sarcopenia, portal hypertension, and variceal bleeding who receive TIPS with or without BCAA supplements.",[294,60,27,247,181],"BCAA",[181,247,296,60,294],"Portal Hypertension","2025-12-02",{"date":299,"type":38},"2025-12-15",{"date":301,"type":38},"2025-11-15",{"date":303,"type":21},"2027-11-15",{"name":305,"class":45},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":313,"targetDuration":173,"studyType":57,"phases":4,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":46},"100602370","2d-shear-wave-spleen-elastography-in-clinically-significant-portal-hypertension-and-high-risk-varices-100602370","NCT07122622","2D-shear Wave Spleen Elastography in Clinically Significant Portal Hypertension and High-risk Varices","Role of 2D-shear Wave Spleen Elastography in Assessing Clinically Significant Portal Hypertension and High-risk Varices in Patients With Advanced Compensated Chronic Liver Disease.","Inclusion Criteria:\n\n* Age greater than 18 years;\n* SWE-LSM ≥9 kPa and\u002For TE-LSM ≥15 kPa;\n\nExclusion Criteria:\n\n* Presence of transjugular intrahepatic porto-systemic shunt (TIPS);·\n* Surgical absence of the spleen;\n* Grade 3 ascites;\n* History of variceal bleeding;\n* Refusal to participate in the study.",{"count":314,"type":21},450,"The primary objective of this study is to evaluate the role of spleen shear wave elastography (SWE-SSM) for ruling in and ruling out clinically significant portal hypertension (CSPH) in patients with compensated advanced chronic liver disease (cACLD) and for ruling in and ruling out high-risk esophageal varices (HRV) in patients with CSPH. Secondary objectives of the study include the investigation of the correlation between SWE-SSM and portal pressure in a subgroup of patients undergoing hepatic venous pressure gradient (HVPG) measurement and between SWE-SSM and transient elastography (TE-SSM).\n\nThe values of SWE-SSM and SWE-LSM will be assessed during the ultrasound examination to which the patient will be subjected according to their care pathway. If inclusion criteria are met and informed consent is obtained, spleen elastography will be carried out (in addition to the routine SWE-LSM planned in clinical practice). Spleen elastography will not alter the standard ultrasound examination but represents a non-invasive diagnostic addition.\n\nThere will be no treatment or experimental intervention that will modify the patient's condition or directly influence their clinical course. The aim is to collect data based on clinical observations without altering the treatment or the natural course of the disease.",[27,317],"Esophageal Varices","2025-11-24",{"date":320,"type":38},"2025-11-25",{"date":322,"type":38},"2025-08-20",{"date":324,"type":21},"2027-08-20",{"name":112,"class":45},{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":335,"conditions":336,"keywords":337,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":77},"100582266","carpeus--effect-of-carvedilol-on-the-portosystemic-gradient-as-measured-by-endoscopic-ultrasound-100582266","NCT06861075","CARPEUS : Effect of Carvedilol on the Portosystemic Gradient as Measured by Endoscopic Ultrasound","CARPEUS","Inclusion Criteria:\n\n* Patients ≥ 18 years\n* Suspected portal hypertension associated with cirrhosis (of any aetiology) as defined by:\n\n  1. Baveno VII criteria :\n\n     Liver stiffness ≥ 25 kPa Or Liver stiffness between 20 and 25 kPa and platelets \\\u003C 150 G\u002FL Or Liver stiffness between 15 and 20 kPa and platelets \\\u003C 110 G\u002FL Or Liver stiffness \\> 20 kPa and\u002For platelets \\\u003C 150 G\u002FL in patients with cirrhosis due to NASH\n\n     Or Oesophageal varices with high risk of bleeding :\n\n     Size \\> 5 mm (stage 2 or 3) Or Size ≤ 5 mm and red spots Or Size ≤ 5 mm and Child-Pugh score C\n  2. and\u002For the presence of a radiological sign of portal hypertension : Portosystemic shunts: rectal varices, splenorenal shunts, repermeabilization of the umbilical vein.\n  3. and\u002For splenic elasticity \\> 50 kPa.\n* Patients naive to treatment with cardioselective beta blockers\n* Affiliated to french health insurance system\n\nExclusion Criteria:\n\n* Absolute contraindications to beta blockers :\n\n  * hypersensitivity to the active substance (carvedilol) or to any of the excipients listed in section 6.1 of the summary of product characteristics\n  * patients with severe decompensated heart failure, with signs of fluid overload (oedema, ascites, pulmonary stasis rales), and\u002For requiring treatment with a positive inotrope or venous vasodilator\n  * second and third-degree atrioventricular blocks (unless presence of a permanent pacemaker)\n  * severe bradycardia (≤ 50 bpm)\n  * cardiac sinus disease (including sino-auricular block)\n  * severe hypotension (systolic pressure \\\u003C 85 mm Hg)\n  * cardiogenic shock\n  * severe asthma, severe chronic obstructive pulmonary disease, history of severe bronchospasm\n  * history of anaphylactic reaction\n  * Raynaud's phenomenon\n  * peripheral circulatory disorder: severe obliterative arterial disease of the lower limbs\n  * association with cimetidine\n  * association with class I antiarrhythmics except lidocaine\n  * pulmonary arterial hypertension\n* Presence of severe acute alcoholic hepatitis (Madrey score ≥ 32).\n* Current hepatic encephalopathy ≥ Grade 2.\n* Ongoing hepato-renal syndrome.\n* Profuse clinical ascites (only if it interferes with the feasibility of echo-endoscopy).\n* History of oesophageal varices rupture.\n* Hepatocellular carcinoma active or in remission for less than six months.\n* Active or resolved portal vein thrombosis for less than six months.\n* History of digestive surgery that does not allow the porto-systemic gradient to be measured using echo-endoscopy (gastrectomy, by-pass, etc.).\n* Patients taking antiaggregants (except acetylsalicylic acid) or anticoagulants for embologenic CA\u002FFA.\n* Severe stage 4 chronic renal insufficiency or stage 5 end-stage renal insufficiency (clearance \\\u003C 30 mL\u002Fmin).\n* Pregnant or breast-feeding women, or those planning to become pregnant\\*.\n\n  \\*A pregnancy test will be carried out for women of childbearing potential, and the investigator will ensure that effective contraception is in place while Carvedilol is being taken and for 5 half-lives after stopping it.\n* Patients protected by law (under guardianship, curatorship or safeguard of justice) or deprived of their freedom.\n* Patients currently taking part in another clinical research protocol.\n* Patients who do not understand French language.",{"count":56,"type":21},[24],"The purpose of this study is to assess the efficacy after one month of treatment with Carvedilol (12.5 mg daily) in primary prophylaxis of digestive haemorrhage due to portal hypertension in cirrhosis, by endoscopic ultrasound-guided portal pressure gradient measurement.",[60,27],[338,339,340],"Carvedilol.","Portal hypertension in cirrhosis.","EUS-PPG measurement.","2025-09-17",{"date":343,"type":38},"2025-09-22",{"date":345,"type":38},"2025-04-16",{"date":347,"type":21},"2028-04-01",{"name":349,"class":45},"University Hospital, Clermont-Ferrand",{"id":351,"slug":352,"hasResults":11,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":22,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":4},"100597730","endoscopic-ultrasound-guided-measurement-of-portal-vein-pressure-gradient-100597730","NCT07062289","Endoscopic Ultrasound-guided Measurement of Portal Vein Pressure Gradient","Study on the Measurement of Portal Vein Pressure Gradient Guided by Endoscopic Ultrasound Based on Portal Vein Thrombosis and Portal Hypertension","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* History of liver cirrhosis\n* INR \\\u003C 1.5\n* Platelet count \\> 50 × 10⁹\u002FL\n* Patients agreed to HVPG and EUS-PPG measurements\n\nExclusion Criteria:\n\n* Patients with ascites\n* Patients with renal insufficiency\n* Patients with active infection\n* Patients with hepatic encephalopathy\n* Critically ill patients\n* Pregnant patients\n* Patients with immunodeficiency diseases (such as systemic lupus erythematosus)\n* Patients with mental illness\n* Patients with malignant tumors\n* Patients who refused to undergo HVPG and EUS-PPG measurements",{"count":358,"type":21},42,[24],"This study aims to evaluate the accuracy and safety of a novel endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement technique in 42 adults with liver cirrhosis and portal vein thrombosis (blood clots in the liver's main vein), a condition where current standard testing (HVPG) fails to provide reliable pressure readings. Participants will undergo both EUS-PPG (using a specialized needle under ultrasound guidance) and HVPG procedures to compare results; EUS-PPG will be performed under general anesthesia in a left-side lying position-an innovative approach-while also enabling immediate endoscopic treatment of bleeding veins if detected during the same session. The primary goals are to validate EUS-PPG's safety in this high-risk group, establish its correlation with HVPG, and pioneer an integrated diagnosis-treatment protocol to reduce hospital stays and costs. The study runs from July 2025 to June 2027 at Zhejiang University School of Medicine.",[124,27],"2025-07-11",{"date":364,"type":38},"2025-07-14",{"date":366,"type":21},"2025-07-01",{"date":368,"type":21},"2027-06-30",{"name":370,"class":45},"Zhejiang University",{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":22,"phases":381,"briefSummary":383,"conditions":384,"keywords":385,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":46},"100568902","phase-2-effects-of-metformin-on-hepatic-venous-pressure-gradient-in-patients-with-cirrhosis-and-portal-hypertension-100568902","NCT06687265","Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension","Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension - A Randomized Placebo-controlled Study","Hyper-Met","Inclusion Criteria:\n\n* \\- Age ≥ 18 years\n* Written informed consent to participate in the study\n* Medical insurance coverage\n* For child-bearing aged women, contraception using oestroprogestative, progestative, intrauterine device, or mechanical contraception\n* Diagnosis of cirrhosis based on a liver biopsy, or on clinical, biological, endoscopic, and radiological evidence\n* Active cause of cirrhosis, or resolution (alcohol cessation, sustained virological response to direct-acting antiviral treatment for HCV, initiation of nucleoside\u002Fnucleotide analog treatment for HBV) for at least 6 months\n* Child-Pugh A or B\n* High likelihood of HVPG ≥ 12 mm Hg based on investigator's judgement, or on the following criteria:\n\n  1. Investigator's judgement\n  2. active cause of cirrhosis and:\n\n     * History of clinical ascites\n     * Or history of variceal bleeding\n     * Or liver stiffness by VCTE ≥ 35 kPa on carvedilol in the last two years\n     * or spleen stiffness by VCTE ≥ 55 kPa on carvedilol in the last two years\n     * or liver surface nodularity ≥ 2,9 in the last two years\n     * or HVPG \\> 16 mm Hg prior to starting NSBB\n     * or Laennec 4c cirrhosis on histology\n  3. or resolution of the cause of cirrhosis for at least 6 months and:\n\n     * history of clinical ascites in the last 6 months\n     * or history of variceal bleeding in the last 6 months\n     * or liver stiffness by VCTE ≥ 35 kPa on carvedilol in the last 6 months\n     * or spleen stiffness by VCTE ≥ 55 kPa on carvedilol in the last 6 months\n     * or liver surface nodularity ≥ 2,9 in the last 12 months\n     * or Laennec 4c cirrhosis on histology in the last 12 months\n* Treatment with carvedilol (≥ 6,25 mg\u002Fday) at a stable dose for at least one month\n* Absence of hepatocellular carcinoma outside at least one nodule \\> 3 cm in diameter, or more than 3 nodules, on ultrasound, CT-scan or MRI performed during the previous 6 months\n\nExclusion Criteria:\n\n* Serum total bilirubin \\> 50 µmol\u002FL\n* Prothrombin ratio \\\u003C 50 %\n* Transaminases \\> 5 ULN\n* Need for at least one paracentesis for ascites fluid evacuation in the last 6 months\n* Expected follow-up \\\u003C 3 months\n* Known hypersensitivity to the active substance or any of the excipients\n* History of lactic acidosis, diabetic acidocetosis, or diabetic precoma\n* Ongoing condition that may lead to acute kidney injury or hypoxia: dehydration, severe infection, shock, cardiac decompensation, respiratory failure, or myocardial infarction within the past month\n* Known hypersensitivity to all the iodin-containing contrast agents\n* Known hypersensitivity to lidocaine for local anesthesia\n* Known hypersensitivity to beta-lactam antibiotics if the patient has a history of valve replacement\n* Alcohol consumption \\> 14 units\u002Fweek for women or \\> 21 units\u002Fweek for men, current or abstinent for less than 6 months\n* Biliary cirrhosis\n* Hepatocellular carcinoma with at least one nodule \\> 3 cm in diameter, or more than 3 nodules\n* Cholangiocarcinoma\n* Extra-hepatic cancer without remission\n* Severe chronic kidney disease defined as estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1,73m2 using the MDRD-6 formula\n* Ongoing treatment with metformin, or discontinued for less than 3 months\n* Treatment with statins started or discontinued for less than 3 months\n* Treatment with nucleoside\u002Fnucleotide analogue for HBV, or direct-acting antiviral treatment for HCV, started for less than 6 months\n* Complete portal vein thrombosis (main portal trunk, or right branch), or portal cavernoma\n* History of TIPS (transjugular intrahepatic portosystemic shunt) \u002F surgical portosystemic derivation \u002F liver transplantation \u002F major hepatectomy\n* Ongoing participation in another interventional therapeutic trial\n* Pregnant or breastfeeding women\n* Patients unable to give consent (under guardianship or curatorship)\n* Non-randomisation criteria: HVPG \\\u003C 12 mm Hg at the catheterism performed during the first follow-up visit",{"count":380,"type":21},76,[382],"PHASE2","Portal hypertension (PHT) is defined by an elevated pressure gradient between the portal vein and the hepatic veins ≥ 5 mm Hg, and is the main vector of complications in cirrhosis.\n\nWhen the hepatic venous pressure gradient (HVPG) is ≥ 10 mm Hg, it is considered as a \" clinically significant PHT \": ascites and oesophageal varices (EV) may occur.\n\nAbove 12 mm Hg, there is a risk of variceal bleeding. Carvedilol, a non-selective beta-blocker (NSBB), is recommended in all the patients with cirrhosis and clinically significant PHT in order to prevent decompensation of cirrhosis.\n\nNevertheless, 40 % of patients are NSBB non-responders, i.e. they do not show a significant decrease in HVPG. In addition, NSBB responders treated for primary prophylaxis have an incidence of variceal bleeding of approximately 10% per year, with a six-week mortality of 20%. Therefore, there is an unmet need for PHT in patients with cirrhosis who do not respond to NSBB, and also for an increase in efficacy in responders. In a randomised pilot study, Rittig et al. observed a mean change in HVPG of -2,9 mm Hg in 16 patients with cirrhosis and HVPG ≥ 12 mm Hg, not treated with NSBB, 90 minutes after ingestion of 1000 mg metformin.\n\nThe study will be a prospective, national, multicentre, phase II, superiority comparative randomized (1:1) simple-blinded clinical trial with two parallel arms: metformin versus placebo.\n\nThe main objective is to evaluate the effect of metformin versus placebo during 28 days on HVPG, in patients with cirrhosis and a HVPG ≥ 12 mm Hg already treated with carvedilol.\n\nSubjects randomized in the metformin group or placebo group will receive metformin ou placebo, one pill of 500 mg per os twice a day (one in the morning and one in the evening, during or at the end of the meal) for 28 days.",[60,27],[32,29,386,387,388],"metformin","hepatic venous pressure gradient","carvedilol","2025-04-09",{"date":391,"type":38},"2025-04-13",{"date":393,"type":38},"2025-03-10",{"date":395,"type":21},"2027-07-31",{"name":397,"class":45},"Assistance Publique - Hôpitaux de Paris",{"id":399,"slug":400,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":405,"targetDuration":4,"studyType":22,"phases":407,"briefSummary":408,"conditions":409,"keywords":410,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":418,"leadSponsor":420,"locationsCount":421},"100580490","ai-guided-tips-procedure-100580490","NCT06837974","AI-guided TIPS Procedure","Construction and Application of an AI Model for Guided TIPS Surgical Puncture: a Prospective Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Participants who require transjugular intrahepatic portosystemic shunt (TIPS) and meet the clinical indications for the procedure.\n* Participants whose physical condition is suitable for TIPS.\n\nExclusion Criteria:\n\n* Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.\n* Participants are pregnant or breastfeeding.\n* Participants are unwilling or unable to sign informed consent.",{"count":406,"type":21},180,[24],"The goal of this clinical trial is to learn if transjugular intrahepatic portosystemic shunt (TIPS)-guided AI model can guide TIPS procedure in adults better than conventional TIPS procedure (artificially blinded TIPS). TIPS surgical outcomes and intraoperative and postoperative complications will also be observed. The main questions it aims to answer are:\n\n* Does the AI model lower the number of punctures, radiation dose, and complications of participants undergo TIPS?\n* Does the AI model improve the efficacy of TIPS for participants?\n\nParticipants will:\n\n* Take the TIPS by the guidance of the AI model or conventional manually blinded penetration (placebo)\n* The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications within 3 months will be recorded\n* Intraoperative portal pressure gradient drop values, symptoms of ascites and rebleeding within 3 months after TIPS will be reported",[27],[179,411,412,413],"AI","Efficacy","Complications","2025-02-16",{"date":416,"type":38},"2025-02-20",{"date":366,"type":21},{"date":419,"type":21},"2026-10-31",{"name":305,"class":45},3,{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":429,"targetDuration":4,"studyType":22,"phases":431,"briefSummary":432,"conditions":433,"keywords":434,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":4},"100561389","small-diameter-tips-in-patients-with-severe-liver-atrophy-and-variceal-bleeding-100561389","NCT06589531","Small Diameter TIPS in Patients with Severe Liver Atrophy and Variceal Bleeding","6 Mm Shunt Transjugular Intrahepatic Portosystemic Shunt in Patients with Severe Liver Atrophy and Variceal Bleeding:A Prospective Single-center Randomized Controlled Study","Inclusion Criteria:\n\n1. Diagnosed as cirrhosis\n2. Previous or present endoscopic diagnosis of esophageal and gastric varices bleeding.\n3. Child -Pugh score C (≤13) or MELD≤18.\n4. Enhanced image measurement of liver volume ≤1000cm3.\n5. Have indications for TIPS treatment.\n6. Researchers believe that patients have the ability to comply with the research plan.\n7. Sign the informed consent form\n\nExclusion Criteria:\n\n1. Malignant tumor (including hepatocellular carcinoma) or other diseases that will shorten the life span of patients.\n2. Cavernous portal vein\n3. Non-cirrhotic portal hypertension (Budd-Chiari syndrome, extrahepatic portal vein obstruction, idiopathic portal hypertension, etc.)\n4. Spontaneous dominant hepatic encephalopathy 5 congestive heart failure or severe valvular heart failure\n\n6\\. Uncontrollable systemic infection or inflammation 7. Severe pulmonary hypertension 8. Severe renal insufficiency (except hepatogenic renal insufficiency) 9. Rapidly progressing liver failure 10. Contrast agent allergy 11. History of liver transplantation or allogeneic organ transplantation 12. Have a history of TIPS or shunt operation. 13. Pregnancy or lactation 14. Poor compliance 15. Participate in another clinical study.",{"count":430,"type":21},120,[24],"Portal hypertension is the most common complication in patients with end-stage liver cirrhosis. Portal hypertension-related complications, such as variceal bleeding, often lead to a poor prognosis. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective treatment strategy for managing portal hypertension-related variceal bleeding. However, the appropriate diameter of the covered stent during the TIPS procedure remains a subject of debate. To date, there is a lack of strong evidence regarding the most suitable covered stent diameter.\n\nIn theory, a shunt with a larger diameter can result in better stent patency, but it can also lead to reduced liver function and a higher incidence of hepatic encephalopathy (HE) after the TIPS procedure. Therefore, the choice of covered stent diameter needs to consider the factors of shunt efficacy and postoperative liver function. At present, the diameters of TIPS-dedicated stents are typically either 8 or 10 mm. Whether stents with these two diameters can meet all the requirements of TIPS procedures is currently unknown. Different races, cirrhosis etiologies, and liver volumes may require different TIPS diameters. For example, in China, most cases of liver cirrhosis are caused by hepatitis B, resulting in the patient having a smaller liver volume. Therefore, in most Chinese studies, the diameters of TIPS stents are mainly 8 mm. Previous studies have shown that TIPS with an 8-mm covered stent has a shunt effect similar to that of a 10-mm covered stent; however, the incidence of postoperative HE is significantly reduced with an 8-mm stent (27% vs. 43%)14. Nevertheless, an 8-mm covered TIPS still has a high incidence of HE.\n\nThe residual liver volume is small for patients with severe atrophic cirrhosis of the liver, and whether this necessitates a covered TIPS with a smaller diameter requires further study. However, there is still no dedicated TIPS stent that is \\<8 mm in diameter. In this study, we propose an innovative strategy for the creation of a 6-mm shunt to determine if it can achieve a shunt effect similar to that of an 8-mm covered TIPS and reduce the incidence of HE in patients with severe atrophic liver cirrhosis.",[27],[67,179,435,436,437],"shunt diameter","hepatic encephalopathy","stent patency","2024-09-09",{"date":440,"type":38},"2024-09-19",{"date":442,"type":21},"2024-09-15",{"date":444,"type":21},"2028-09-15",{"name":446,"class":45},"Huang Mingsheng"]