[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619825":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":75,"collaborators":77,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":26,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":26,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":26,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"The Second Affiliated Hospital of Chongqing Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"underdilation group","EXPERIMENTAL","Patients in this group will receive a underdilated strategy during TIPS procedure by using a 6mm balloon to dilate the puncture tract and subsequently implanted 8mm Viatorr stent.",[13],"Device: 6mm balloon dilation",{"label":15,"type":16,"description":17,"interventionNames":18},"full-dilation group","ACTIVE_COMPARATOR","Patients in this group will receive a fully-dilated strategy during TIPS procedure by using a 8mm balloon to dilate the puncture tract and subsequently implanted 8mm Viatorr stent.",[19],"Device: 8mm balloon dilation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","6mm balloon dilation","A 6mm balloon was used to under-dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"8mm balloon dilation","A standard 8mm balloon was used to fully dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Yongjun Zhu, Doctor","CONTACT","86-13281121937","hp545204493@126.com",[38,59],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Chongqing","Chongqing Municipality","400072","China","CN",{"type":46,"coordinates":47},"Point",[48,49],106.55771,29.56026,{"lat":49,"lon":48},[52,56],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":55},"Song He, Doctor","+86 13281121937","hedoctor65@cqmu.edu.cn",{"name":57,"role":58,"phone":26,"phoneExt":26,"email":26},"Yongjun Zhu","PRINCIPAL_INVESTIGATOR",{"facility":60,"status":39,"city":61,"state":41,"zip":62,"country":43,"countryCode":44,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Qianjiang Central Hospital","Qianjiang","409099",{"type":46,"coordinates":64},[65,66],108.77478,29.53284,{"lat":66,"lon":65},[69,73],{"name":70,"role":34,"phone":71,"phoneExt":26,"email":72},"Fei Xiang","86-23-79246331","xinagfei123@126.com",{"name":70,"role":74,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":76,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[78,80],{"name":79,"class":6},"West China Hospital",{"name":81,"class":82},"Qianjiang Hospital, Chongqing University","UNKNOWN","100619825","underdilated-stent-technique-improves-post-tips-encephalopathy-100619825",false,"NCT07349654","Underdilated-stent Technique Improves Post-TIPS Encephalopathy","Underdilated-stent Technique Improves Post-transjugular Intrahepatic Portosystemic Shunt Encephalopathy: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Liver cirrhosis, defined by clinical manifestations, biochemical indicators, imaging examinations, or liver biopsy;\n* History of esophagogastric variceal bleeding, or refractory\u002Frecurrent ascites;\n* Intended to undergo TIPS treatment.\n\nExclusion Criteria:\n\n* Non-cirrhotic portal hypertension;\n* Previous treatments that may affect portal pressure, such as TIPS or surgical procedures;\n* History of overt hepatic encephalopathy (West-Haven classification ≥2);\n* Malignant tumors in advanced stages;\n* Concomitant irreversible heart, liver, kidney, or respiratory failure;\n* Unable or unwilling to sign the informed consent form.","ALL","18 Years","75 Years",{"count":94,"type":95},72,"ESTIMATED","INTERVENTIONAL",[98],"NA","Transjugular intrahepatic portosystemic shunt (TIPS) is a critical therapeutic approach for managing esophagogastric variceal bleeding and refractory ascites in decompensated cirrhosis patients. To date, hepatic encephalopathy (HE) remains one of the most common complications following TIPS procedures, and prediction and prevention of post-TIPS HE have always been a hotspot in the field of hepatology. However, no reliable clinical studies have confirmed that any drug or intervention can effectively prevent the occurrence of HE episodes following TIPS, including lactulose and rifaximin.\n\nUnderdilated strategy (UDS) was reported as an development technique proposed in recent years for TIPS procedures, which involves using a small-diameter balloon to dilate the puncture tract and subsequently implanted standard-diameter covered stent (e.g., 8 mm). This allows the stent to maintain a smaller diameter shortly after release, thereby reducing the incidence of hepatic encephalopathy during the postoperative period. Over time, the stent gradually dilates to its normal diameter within months. This period coincides with the higher incidence risk of post-TIPS HE, most commonly occurring within 6 months, especially within the first 3 months after TIPS. Therefore, theoretically, UDS can reduce the occurrence of post-TIPS HE. In terms of clinical research, however, there were still no high quality studies reported the advantages of this technique. Current reported clinical studies were all non-randomized controlled trials or retrospective studies, with low-quality evidence and sometimes contradictory findings.\n\nThe aim of this prospective randomized controlled clinical study is to evaluate whether administration of underdilated technology during TIPS can improve postoperative hepatic encephalopathy, without compromising the therapeutic efficacy of portal hypertension complications.",[101,102,103,104],"Liver Cirrhosis","Variceal Bleeding, Cirrhosis","Ascites Hepatic","Hepatic Encephalopathy (HE)","2026-01-09",{"date":107,"type":108},"2026-01-20","ACTUAL",{"date":110,"type":108},"2024-11-19",{"date":112,"type":95},"2027-12-31",{"name":5,"class":6},2]