[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100355034":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":62,"collaborators":20,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":20,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":20,"enrollmentInfo":73,"targetDuration":20,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":86,"whyStopped":20,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Mansoura University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EUS - FNA for benign PVT by imaging","EXPERIMENTAL","Intervention: Procedure\u002FSurgery: EUS guided fine needle aspiration of portal vein thrombus",[13],"Procedure: EUS guided fine needle aspiration of portal vein thrombus",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","EUS guided fine needle aspiration of portal vein thrombus","endoscopic ultrasound guided fine needle aspiration of portal vein thrombus which did not fulfill criteria of malignancy by imaging technique",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Magdy H. Atwa, Professor","Faculty of Medicine, Mansoura University","STUDY_CHAIR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Dina S. Eskandere","CONTACT","01148979995","dinaeskandere@mans.edu.eg",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Ahmad Y. Altonbary, MD","01005100091","Altonbary@gmail.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"specialized medical hospital, Mansourah University","RECRUITING","Al Mansurah","Dakahlia Governorate","35516","Egypt","EG",{"type":46,"coordinates":47},"Point",[48,49],31.38069,31.03637,{"lat":49,"lon":48},[52,54,57,59,61],{"name":53,"role":29,"phone":30,"phoneExt":20,"email":31},"dina S. eskandere, Master",{"name":55,"role":56,"phone":20,"phoneExt":20,"email":20},"Dina S. Eskandere, Master","PRINCIPAL_INVESTIGATOR",{"name":33,"role":58,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"name":60,"role":58,"phone":20,"phoneExt":20,"email":20},"Hazem H. ElBeltagy, MD",{"name":23,"role":58,"phone":20,"phoneExt":20,"email":20},{"type":63,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100355034","role-of-eus-guided-fna-of-portal-vein-thrombus-in-the-diagnosis-and-staging-of-hepatocellular-carcinoma-100355034",false,"NCT03902678","Role of EUS Guided FNA of Portal Vein Thrombus in the Diagnosis and Staging of Hepatocellular Carcinoma","Role of Endoscopic Ultrasound Guided Fine Needle Aspiration of Portal Vein Thrombus in the Diagnosis and Staging of Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Patients with liver cirrhosis and PVT which don't fulfill criteria of malignancy by triphasic CT abdomen defined as, (neovascularity of thrombus, arterial enhancement with rapid washout, direct invasion by adjacent hepatic mass and diameter of thrombus more than 23 mm), either :\n* With or without hepatic mass\n* Undergone local treatment or surgical treatment following a diagnosis of HCC and develop PVT during their follow up.\n\nExclusion Criteria:\n\n* Uncooperative or excessively apprehensive patient\n* Anticoagulation treatment or non-substituted coagulopathy (International Normalized Ratio ≥ 1.5, Platelet count ≤ 50.000 cells\u002Fmm3, heparin administration at therapeutic doses).\n* Inhibition of platelet aggregation by clopidogrel and other thienopyridines.\n* Contraindications of sedation (Uncontrolled Diabetes Mellitus, Uncontrolled Thyroid Disorders, Pregnancy, Respiratory Embarrassment, Reactional Drugs like Antidepressants and Anti-anxiety Agents).\n* Patients fulfilling criteria of malignancy by triphasic CT on abdomen.\n* Extra hepatic metastasis of HCC.\n* Child-Pugh classification stage C.","ALL","18 Years",{"count":74,"type":75},30,"ESTIMATED","INTERVENTIONAL",[78],"NA","Since not every portal vein thrombus (PVT) in a patient with hepatocellular carcinoma (HCC) is a tumor thrombus, since the nature of the thrombus will ultimately determine the course of treatment, and since PVT may be even the initial sign of an undetected HCC, every effort should be made to distinguish between a tumor and a non-tumor PVT. In addition, malignant PVT does not always demonstrate neovascularity and\u002For enhancement, which makes fine needle aspiration (FNA) necessary in order to characterize the nature of the PVT.\n\nSampling of portal vein thrombus with trans-abdominal ultrasound guidance may lead to erroneous results because of inadvertent inclusion of normal hepatocytes or associated liver masses. Further, potential adverse events of trans-abdominal portal vein sampling include serious biliary and\u002For vascular injury.\n\nIn contrast to the percutaneous approach, Endoscopic ultrasound (EUS) provides a unique view and access to the main portal vein. From the duodenal bulb and second part of the duodenum, the portal vein can be visualized from the confluence of the splenic and superior mesenteric veins into the porta hepatis. Periportal collateral vessels or cavernous transformation of the portal vein, which commonly are associated with portal vein thrombosis, are also easily and reliably detected by EUS instruments with color Doppler US capability.\n\nWith a linear-array echo-endoscope, the portal vein can be punctured easily with a fine needle under direct visualization, while avoiding the adjacent hepatic artery, bile duct, and collateral vessels (if present). Because the approach is not trans-hepatic, it eliminates any need to avoid the primary tumor and any possibility of contaminating the specimen with hepatocytes, as can occur if the needle tracks through the liver parenchyma. Thus, the rate of false-positive diagnoses is likely to be lower with the EUS compared with the percutaneous approach",[81],"Portal Vein Thrombosis",[83,84,85],"EUS","FNA","PVT","UNKNOWN","2019-04-02",{"date":89,"type":90},"2019-04-04","ACTUAL",{"date":92,"type":90},"2017-05-11",{"date":94,"type":75},"2019-07-11",{"name":5,"class":6},1]