[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622140":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":39,"responsibleParty":52,"collaborators":24,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":24,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":76,"whyStopped":24,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Clinical Hospital Colentina","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Control","standard follow up and stent exchange according to institutional norm",[12],"Other: stent exchange",{"label":14,"type":15,"description":16,"interventionNames":17},"rapid exchange","ACTIVE_COMPARATOR","rapid call back in case of positive bile culture",[18],"Other: Scheduled biliary stent exchange at one month",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"stent exchange","standard stent exchange at three months according to the institutional norms",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Scheduled biliary stent exchange at one month","Patients within the active arm will have scheduled stent exchange at one month, in comparison to those in the control arm, which will have scheduled stent exchange at three months, according to the institutional norms in place",[14],[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Bogdan R. Mateescu, Prof. M.D., Ph.D","CONTACT","21 317 3245","+40","bogmateescu@gmail.com",{"name":37,"role":32,"phone":33,"phoneExt":34,"email":38},"Andrei M. Voiosu, M.D., PhD.","andreivoiosu@gmail.com",[40],{"facility":41,"status":24,"city":42,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":24},"Colentina Clinical Hospital","Bucharest","021025","Romania","RO",{"type":47,"coordinates":48},"Point",[49,50],26.10626,44.43225,{"lat":50,"lon":49},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Andrei Voiosu","Lecturer Dr.","100622140","impact-of-positive-bile-cultures-on-plastic-biliary-stent-exchange-100622140",false,"NCT07379749","Impact of Positive Bile Cultures on Plastic Biliary Stent Exchange","TEMPEST 2","Inclusion Criteria:\n\n* All patients between 18 and 90 years old with native papilla and obstructive jaundice of any etiology requiring plastic biliary stent placement, with a positive bile culture at index ERCP who can provide written informed consent (obtained from the patient or legal caregiver).\n\nExclusion Criteria:\n\n* prior ERCP attempts\n* patients with bilio-digestive surgical or endoscopic anastomoses\n* inability to provide informed consent due to cognitive, legal, or medical reasons\n* scheduled surgical resection within one month after ERCP.","ALL","18 Years",{"count":66,"type":67},140,"ESTIMATED","INTERVENTIONAL",[70],"NA","This prospective, unicenter, randomized controlled trial evaluates whether a positive bile culture at index ERCP with plastic stenting identifies patients who benefit from earlier stent exchange. Patients with no previous history of sphincterotomy and positive bile cultures after an ERCP will be randomized to stent exchange at 1 month versus 3 months to assess whether personalized scheduling reduces early stent occlusion and secondary acute cholangitis.",[73],"Acute Cholangitis",[75],"early onset acute cholangitis after subsequent biliary stent occlusion","NOT_YET_RECRUITING","2026-01-23",{"date":79,"type":80},"2026-01-30","ACTUAL",{"date":82,"type":67},"2026-02",{"date":84,"type":67},"2027-02",{"name":5,"class":6},1]