[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"variceal-bleeding\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:variceal-bleeding":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,43,75,99,129,149,178,204,232],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100640764","direct-oral-novel-anticoagulants-for-patients-with-high-risk-gastroesophageal-variceal-bleeding-and-portal-vein-thrombosis-100640764",false,"NCT07602062","Direct Oral Novel Anticoagulants for Patients With High-risk Gastroesophageal Variceal Bleeding and Portal Vein Thrombosis","Multicenter Randomized Controlled Clinical Trial on Direct Oral Novel Anticoagulants for Improving the Prognosis of Cirrhotic Patients With High-risk Gastroesophageal Variceal Bleeding and Portal Vein Thrombosis","Inclusion Criteria:\n\n* Clinical and imaging diagnosis of liver cirrhosis and esophagogastric varices, with at least one previous episode of esophagogastric variceal bleeding\n* Combined with portal vein thrombosis and D-dimer \\> 0.8mg\u002FL\n* Endoscopic evaluation reveals a high risk of variceal bleeding, and endoscopic treatment is performed to prevent rebleeding of esophagogastric varices\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Received other antithrombotic therapies before (including warfarin, aspirin, low-molecular-weight heparin, etc.)\n* Combined with hepatocellular carcinoma or other malignancy\n* Combined with portal cavernoma\n* Combined with severe life-threatening diseases of circulatory, hematological and respiratory system\n* Combined with diseases requiring anticoagulant therapy, such as acute portal vein thrombosis, atrial fibrillation, lower extremity venous thrombosis, and pulmonary embolism\n* Received TIPS or liver transplantation or splenectomy\n* With contraindications to anticoagulant therapy (uncontrollable active bleeding, severe hepatic insufficiency, renal insufficiency, etc.)\n* Currently taking immunosuppressive agents, or medications that affect cytochrome P450 (including azole antifungals and protease inhibitors), or strong inducers of CYP3A4 (including rifampicin, phenytoin, carbamazepine, etc.)","ALL","18 Years","75 Years",{"count":20,"type":21},175,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to explore the safety and efficacy of oral administration of a novel anticoagulant (rivaroxaban) in patients with cirrhosis accompanied by high-risk esophagogastric variceal bleeding and portal vein thrombosis, through a prospective, multicenter, randomized controlled clinical trial, starting 48 hours after endoscopic treatment to prevent rebleeding.",[27,28,29],"Portal Vein Thrombosis","Anticoagulant Therapy","Variceal Bleeding","NOT_YET_RECRUITING","2026-05-16",{"date":33,"type":34},"2026-05-22","ACTUAL",{"date":36,"type":21},"2026-06-01",{"date":38,"type":21},"2027-12-31",{"name":40,"class":41},"Shanghai Zhongshan Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":61,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100636914","ultrasound-prediction-of-esophageal-variceal-bleeding-risk-100636914","NCT07571876","Ultrasound Prediction of Esophageal Variceal Bleeding Risk","Splenic Size and Portal Vein Diameter on Ultrasound in Predicting Esophageal Variceal Bleeding Risk","Inclusion Criteria:\n\n* Adult patients (age ≥18 years) with chronic liver disease and clinical\u002Flaboratory\u002Fradiological evidence of liver cirrhosis\n* Both compensated and decompensated cirrhosis (Child-Pugh classes A, B, and C)\n* Patients scheduled for upper gastrointestinal endoscopy\n* Patients who provide informed consent\n\nExclusion Criteria:\n\n* Previous history of endoscopic variceal band ligation or sclerotherapy\n* Prior surgical portosystemic shunt procedures or transjugular intrahepatic portosystemic shunt (TIPS)\n* Hepatocellular carcinoma with portal vein thrombosis\n* Previous splenectomy\n* Patients receiving beta-blockers for variceal bleeding prophylaxis\n* Poor quality ultrasound images due to obesity or ascites\n* Refusal to participate in the study",{"count":51,"type":21},165,"OBSERVATIONAL","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.\n\nIn 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.",[29,55,56,57,58,59,60],"Ultrasonography","Esophageal Bleeding","Esophageal Varices","Liver Cirrhosis","Portal Hypertension","Chronic Liver Disease (CLD)",[62,63,64,65],"portal vein diameter","splenic size","ultrasound","esophageal variceal bleeding risk","2026-05-04",{"date":68,"type":34},"2026-05-06",{"date":70,"type":21},"2026-04",{"date":72,"type":21},"2027-05",{"name":74,"class":41},"Assiut University",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":42},"100487650","prevention-of-variceal-rebleeding-by-eus-guided-vs-conventional-endoscopic-therapy-in-hepatocellular-carcinoma-patients-100487650","NCT05629845","Prevention of Variceal Rebleeding by EUS-guided vs Conventional Endoscopic Therapy in Hepatocellular Carcinoma Patients","Secondary Prevention of Variceal Rebleeding by Endoscopic Ultrasound-guided Therapy Versus Conventional Endoscopic Therapy in Hepatocellular Carcinoma Patients: a Randomized Controlled Trial","EUS-SPV","Inclusion Criteria:\n\n* Consecutive HCC patients age 18 or older with recent (within 4 weeks of the episode) EV or GV bleeding successfully controlled by conventional endoscopic therapies (VBL for EV or glue injection for GV)\n* Able to provide written informed consent to participate in the study and comply with the study procedures\n\nExclusion Criteria:\n\n* Unable to provide written informed consent\n* Contraindications for endoscopy due to underlying comorbidities\n* HCC patients with non-variceal source of gastrointestinal bleeding\n* Refractory coagulopathy (INR\\>1.5) or refractory thrombocytopenia (platelets \\\u003C50,000) despite blood product transfusion\n* Moribund patients from terminal illness",{"count":84,"type":21},84,[24],"Rebleeding rate is high in hepatocellular carcinoma (HCC) patients with variceal bleeding despite conventional endoscopic therapies for esophageal and gastric varices (EV, GV). Secondary prevention of variceal rebleeding was reported to improve outcomes of HCC patients, but the optimal endoscopic approach is not well defined. In this difficult-to-manage population, variceal rebleeding rates remain substantial after conventional endoscopic therapies. n recent studies by others and our group on direct EUS-guided therapy for varices in cirrhotic patients, high technical success (90 - 100%), low post-treatment rebleeding rate (3 - 11%) and low adverse event rate (\\~3%) have been reported for GV treatment by cyanoacrylate glue injection, coiling or a combination of both, and for cyanoacrylate glue injection or coiling of EV refractory to variceal band ligation (VBL). This study aims to compare rebleeding rates after secondary prevention by EUS-guided therapy or conventional endoscopic therapy in HCC patients with recent variceal bleeding.",[88,29],"Hepatocellular Carcinoma","RECRUITING","2026-03-17",{"date":92,"type":34},"2026-03-19",{"date":94,"type":34},"2022-11-22",{"date":96,"type":21},"2026-12-31",{"name":98,"class":41},"Chinese University of Hong Kong",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":42},"100629120","fiber-optic-navigation-during-tips-creation-a-prospective-pilot-study-100629120","NCT07470515","Fiber-Optic Navigation During TIPS Creation: A Prospective Pilot Study","Fiber-Optic Navigation During Transjugular Intrahepatic Portosystemic Shunt Creation: A Prospective Pilot Study Evaluating Procedural Parameters","FLIGHT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Clinical indication for transjugular intrahepatic portosystemic shunt (TIPS) creation according to standard clinical practice (e.g., refractory ascites or variceal bleeding)\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide informed consent\n* Pregnancy or breastfeeding\n* Absolute contraindications to TIPS according to current clinical standards (e.g., severe right heart failure, uncontrolled systemic infection)\n* Participation in another clinical study that may interfere with the results of this study",{"count":108,"type":21},30,[24],"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.\n\nThis 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.\n\nApproximately 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.\n\nThe results may help to improve procedural efficiency and radiation safety during TIPS interventions.",[58,112,29,59],"Refractory Ascites",[114,59,115,116,117,118,119],"TIPS","Interventional Radiology","Fiber-Optic Navigation","Image-Guided Intervention","Endovascular Navigation","Radiation Reduction","2026-03-10",{"date":122,"type":34},"2026-03-13",{"date":124,"type":21},"2027-01",{"date":126,"type":21},"2028-12",{"name":128,"class":41},"Medical University Innsbruck",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":138,"studyType":52,"phases":4,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":42},"100625214","construction-of-a-portal-hypertension-biobank-100625214","NCT07419724","Construction of a Portal Hypertension Biobank","Construction of a Biobank for a Specialized Cohort of Portal Hypertension","Inclusion Criteria:\n\n1. Clinically diagnosed with portal hypertension complicated by esophagogastric varices.\n2. Underwent abdominal CT examination\n\nExclusion Criteria:\n\n1. Imaging or endoscopic evidence demonstrating absence of esophageal and\u002For gastric varices.\n2. CT image quality not meeting requirements or incomplete medical history data.",{"count":137,"type":21},1000,"3 Years","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.\n\nThis study aims to expand the established portal hypertension biobank by extending the temporal depth of clinical cohort data and diversifying sample types.",[29,59],"2026-02-12",{"date":143,"type":34},"2026-02-19",{"date":145,"type":34},"2025-10-16",{"date":147,"type":21},"2031-12-31",{"name":40,"class":41},{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":158,"studyType":52,"phases":4,"briefSummary":159,"conditions":160,"keywords":163,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"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":157,"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.",[161,29,162],"Ascites","Portal Hypertension Related to Cirrhosis",[164,114,165,166,167],"portal hypertension","cirrhosis","decompensated","Transjugular Intrahepatic Portosystemic Shunt","2026-02-05",{"date":170,"type":34},"2026-02-10",{"date":172,"type":21},"2026-06",{"date":174,"type":21},"2029-09-30",{"name":176,"class":177},"W.L.Gore & Associates","INDUSTRY",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":42},"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.",{"count":186,"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 .",[162,190,29],"Ascites Hepatic",[192,193,194],"Transjugular intrahepatic portosystemic shunt","TIPS stent","patency","2025-12-18",{"date":197,"type":34},"2025-12-19",{"date":199,"type":34},"2024-11-21",{"date":201,"type":21},"2027-01-01",{"name":203,"class":177},"C. R. Bard",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":215,"conditions":216,"keywords":219,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":42},"100583845","phase-4-tranxemic-acid-and-vitamin-k-injection-to-control-upper-gastrointestinal-bleeding-in-cirrhotic-patients-100583845","NCT06881628","Tranxemic Acid and Vitamin K Injection to Control Upper Gastrointestinal Bleeding in Cirrhotic Patients","Efficacy of Tranexamic Acid and Vitamin k Injection in Control of Upper Gastrointestinal Bleeding in Egyptian Cirrhotic Patients: A Randomized Controlled Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Liver cirrhosis\n* Upper gastrointestinal bleeding\n\nExclusion Criteria:\n\n* Patients aged \\\u003C 18 years\n* Allergy to tranexamic acid\n* Allergy to vitamin K injection\n* DIC.\n* Thromboembolic event.\n* Pregnancy or lactation.\n* End-stage renal disease.\n* Unwilling to participate in our study.",{"count":212,"type":21},194,[214],"PHASE4","The goal of this randomized controlled clinical trial is to evaluate the efficacy of Tranexamic acid and vitamin K injection versus placebo in control of upper gastrointestinal bleeding (UGIB) in Egyptian cirrhotic patients.\n\nResearchers will compare the bleeding and mortality rates (at 5 days and 6 weeks post endoscopic intervention for UGIB) between patients receiving tranxemic acid and vitamin K injection and patients receiving placebo.\n\nParticipants presenting with variceal bleeding will be randomly assigned to receive tranexamic acid (1 g loading dose followed by 3 g maintenance dose over 24- 48 hours) and intravenous injection of 10 mg daily of vitamin K for 24-48 h or matching placebo group receiving IV saline. Intervention will be carried out besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy.\n\nFollow-up All patients will be kept at the hospital for at least 5 days from the index bleed and will be discharged if no other reason was observed to keep them at the hospital.\n\nThe rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate were evaluated and compared across the groups.\n\nAt discharge, all patients will be started on nonselective beta-blockers if there was no contraindication. They will be given instructions to attend to hospital if they noticed any melena or hematemesis.\n\nSecond follow-up after 6 weeks for the rebleeding rate and mortality related to bleeding rate.",[217,29,218],"Upper Gastrointestinal Bleeding (UGIB)","Cirrhosis",[220,221,222],"Variceal bleeding","Tranexamic acid and vitamin K","Liver cirrhosis","2025-03-11",{"date":225,"type":34},"2025-03-18",{"date":227,"type":34},"2024-12-02",{"date":229,"type":21},"2025-12-30",{"name":231,"class":41},"Tanta University",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100564048","early-transjugular-intrahepatic-portosystemic-shunt-for-advanced-hepatocellular-carcinoma-100564048","NCT06624098","Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma","Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus Induced Gastrointestinal Bleeding: a Multicenter Phase II Study","Inclusion Criteria:\n\n1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;\n2. presence of PVTT with III-IV grade by Cheng's criteria;\n3. having PVTT induced portal hypertension;\n4. TIPS was performed within 72 hours after the endoscopic hemostasis;\n5. metastases with limited five sites and no more two organs involved;\n6. number of Intrahepatic tumors were no more than five;\n7. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;\n8. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;\n9. no history of other malignancies;\n10. agreed to participated in this clinical trial;\n11. Hemameba ≥3.0 x109\u002FL, neutrophil ≥1.5x109\u002FL, hemoglobin≥10.0 g\u002FL, platelet≥100x 109\u002FL, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml\u002Fmin.\n\nExclusion Criteria:\n\n1. recurrent HCC;\n2. PVTT at I-II grade by Cheng's criteria;\n3. age \\\u003C 18 years or \\> 75 years;\n4. advanced HCC with more than five metastases;\n5. Number of Intrahepatic tumors were more than five;\n6. no response to Lenvatinib;\n7. life expectancy less than 3 months.",{"count":240,"type":21},22,[24],"Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective.",[244,29],"Advanced Hepatocellular Carcinoma",[246,220,247,192],"Advanced hepatocellular carcinoma","Therapeutic endoscopy","2024-10-01",{"date":250,"type":34},"2024-10-02",{"date":248,"type":34},{"date":253,"type":21},"2026-06-30",{"name":255,"class":41},"Sun Yat-sen University",2]