[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571153":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":63,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Institute for Clinical and Experimental Medicine","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Management of anastomotic biliary strictures with biodegradable stents","EXPERIMENTAL","Initially, a single biodegradable stent is used for treatment of an anastomotic biliary stricture. If needed, this may be followed by usage of another biodegradable stent or plastic stents.",[13,14],"Procedure: ERCP implantation of a biodegradable stent","Procedure: ERCP implantation of plastic stents",{"label":16,"type":17,"description":18,"interventionNames":19},"Management of anastomotic biliary strictures with multiple plastic stents in","ACTIVE_COMPARATOR","Multiple plastic stents are used for treatment of an anastomotic biliary stricture.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","ERCP implantation of a biodegradable stent","Endoscopic retrograde cholangiopancreatography (ERCP) with placement of a biodegradable stent to treat anastomotic biliary stricture (possibly combined with removal of previous plastic stents).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"ERCP implantation of plastic stents","Endoscopic retrograde cholangiopancreatography (ERCP) with placement of a plastic stent or multiple stents to treat anastomotic biliary stricture (possibly combined with removal of previous plastic stents).",[9,16],[32],{"name":33,"affiliation":5,"role":34},"Tomas Hucl, Prof","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","420261364016","tomas.hucl@ikem.cz",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Iveta Matulova","420261365154","iveta.matulova@ikem.cz",[45],{"facility":46,"status":47,"city":48,"state":26,"zip":49,"country":50,"countryCode":26,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Institute for Clinical and Experimental Medicine, Department of Gastroenterology and Hepatology","RECRUITING","Prague","140 21","Czechia",{"type":52,"coordinates":53},"Point",[54,55],14.42076,50.08804,{"lat":55,"lon":54},[58,60,62],{"name":33,"role":37,"phone":59,"phoneExt":26,"email":39},"00420261364016",{"name":41,"role":37,"phone":61,"phoneExt":26,"email":43},"00420261365154",{"name":33,"role":37,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Tomas Hucl","Chairman, Department of Gastroenterology and Hepatology","100571153","biodegradable-stents-in-liver-transplant-recipients-for-treatment-of-biliary-anastomotic-strictures-100571153",false,"NCT06716541","Biodegradable Stents in Liver Transplant RecipIents for Treatment of Biliary Anastomotic Strictures","Biodegradable Stents Versus Plastic Stents for Treatment of Biliary Anastomotic Strictures in Liver Transplant RecipIents","BRILLIANT","Inclusion Criteria:\n\n* Age ≥18 years\n* Liver transplant recipients\n* Duct-to-duct biliary anastomosis\n* Anastomotic biliary stricture (cholestasis unexplained by other causes and\u002For liver biopsy showing altered biliary drainage and\u002For anastomotic stricture on MRCP)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Hepaticojejunoanastomosis\n* Physical and\u002For psychological inability to understand the aims of the research and to adequately cooperate\n* Pregnancy","ALL","18 Years",{"count":77,"type":78},70,"ESTIMATED","INTERVENTIONAL",[81],"NA","Biliary complications after liver transplantation (LT) remain common and are associated with higher morbidity in liver transplant recipients and liver graft failure. Anastomotic biliary strictures are the most common biliary strictures after LT. Today, the gold standard for treatment remains endoscopic retrograde cholangiopancreatography (ERCP) with either multiple plastic stenting (MPS) or fully covered metal stents. These methods have disadvantages such as the need for repeated ERCP procedures, high costs or the risk of migration.\n\nBiodegradable stents (BDS) are a novel type of stents made from various synthetic polymers or their copolymers, which are now being used in a variety of medical fields, including the pancreatobiliary tract.The use of biodegradable stents has shown good potential in the treatment of benign biliary strictures. However, overall data on their endoscopic use in liver transplant recipients, particularly in the treatment of anastomotic biliary strictures, are scarce. Most studies have either been in animal models, using percutaneously implanted stents, or in non-transplanted patients. There are no randomised controlled trials investigating their use in LT patients. Based on the available evidence, the use of BDS in the treatment of anastomotic biliary strictures in liver transplant recipients appears to be a promising technique that may be as effective as the standard treatment with MPS, but may reduce the number of ERCP procedures and eliminate the risk of migration.\n\nThe aim of this randomised prospective study is to compare the difference in rates of anastomotic stricture resolution between the active (BDS) and control (MPS) groups to demonstrate non-inferiority of the biodegradable stents. Outcomes will be classified as complete resolution (no significant stricture at the anastomotic site on imaging and resolution of cholestasis), significant response (relative stricture and resolution of cholestasis) or failure (persistent stricture and\u002For persistent cholestasis). Secondary outcomes are technical feasibility, immediate and late complications.",[84,85,86],"Liver Transplant, Complications","Biliary Anastomotic Stenosis","Endoscopic Retrograde Cholangiopancreatography","2024-12-03",{"date":89,"type":90},"2024-12-04","ACTUAL",{"date":92,"type":90},"2024-11-01",{"date":94,"type":78},"2027-12-31",{"name":5,"class":6},1]