[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635998":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":44,"collaborators":46,"id":50,"slug":26,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":26,"enrollmentInfo":59,"targetDuration":26,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":78,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":26},{"fullName":5,"class":6},"Chung-Ang University Hosptial, Chung-Ang University College of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"12-mm Partially Covered SEMS Group","EXPERIMENTAL","Participants in this arm will receive a 12-mm partially covered self-expandable metallic stent (ComVi Biliary Stent) through the existing PTBD tract for unresectable malignant distal biliary obstruction.",[13],"Device: 12-mm partially covered self-expandable metallic stent",{"label":15,"type":16,"description":17,"interventionNames":18},"12-mm Bare SEMS Group","ACTIVE_COMPARATOR","Participants in this arm will receive a 12-mm bare self-expandable metallic stent (Niti-S Biliary Uncovered Stent) through the existing PTBD tract for unresectable malignant distal biliary obstruction.",[19],"Device: 12-mm bare self-expandable metallic stent",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","12-mm partially covered self-expandable metallic stent","A 12-mm partially covered self-expandable metallic stent placed through the existing percutaneous transhepatic biliary drainage (PTBD) tract for internal biliary drainage in patients with unresectable malignant distal biliary obstruction.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"12-mm bare self-expandable metallic stent","A 12-mm bare self-expandable metallic stent placed through the existing percutaneous transhepatic biliary drainage (PTBD) tract for internal biliary drainage in patients with unresectable malignant distal biliary obstruction.",[15],[32],{"name":33,"affiliation":34,"role":35},"Woosun Choi, MD, PhD","Associate Professor, Department of Radiology, Chung-Ang University Hospital","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+82-2-6299-2681","radiochoi527@gmail.com",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},"Jinyoung Choi, MD","hananox@naver.com",{"type":35,"investigatorFullName":45,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Woosun Choi",[47],{"name":48,"class":49},"OSYMED CO., Ltd.","UNKNOWN","100635998",false,"NCT07559968","12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Obstruction","12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Obstruction: A Prospective, Randomized Clinical Study","PCSEMS-12","Inclusion Criteria:\n\n* Patients who voluntarily provide written informed consent after receiving sufficient explanation of the study purpose, methods, and potential benefits and risks\n* Adults aged 19 years or older\n* Patients diagnosed with unresectable malignant distal biliary obstruction based on imaging studies (CT, MRI, ERCP, etc.) or histologic confirmation\n* Patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) according to the institutional clinical protocol and are scheduled for metallic stent placement through the existing PTBD tract\n\nExclusion Criteria:\n\n* Patients with a previous history of biliary metallic stent placement\n* Patients with upper biliary obstruction (hilar level or above)\n* Patients with other major biliary lesions in addition to malignant distal biliary obstruction\n* Patients for whom the investigator judges that study conduct or data collection would be markedly difficult","ALL","19 Years",{"count":60,"type":61},60,"ESTIMATED","INTERVENTIONAL",[64],"NA","Metallic stents are commonly used for biliary drainage in patients with unresectable malignant distal biliary obstruction. However, it is unclear whether a 12-mm partially covered self-expandable metallic stent or a 12-mm bare self-expandable metallic stent provides better effectiveness and safety. This prospective, randomized clinical trial will compare these two stent types in adult patients who have already undergone percutaneous transhepatic biliary drainage (PTBD) and are scheduled for metallic stent placement through the existing PTBD tract. A total of 60 participants will be enrolled. After stent placement, participants will be followed for 12 months, with assessments at 3, 6, and 12 months. The study will evaluate recurrent biliary obstruction, stent patency duration, reintervention, overall survival, and procedure-related complications. The results are expected to provide evidence for selecting the most appropriate 12-mm metallic stent for patients with unresectable malignant distal biliary obstruction.",[67,68,69],"Malignant Distal Biliary Obstruction","Malignant Biliary Obstruction","Biliary Obstruction",[71,72,73,74,75,76,77],"12-mm metallic stent","partially covered self-expandable metallic stent","bare self-expandable metallic stent","malignant distal biliary obstruction","PTBD","recurrent biliary obstruction","stent patency","NOT_YET_RECRUITING","2026-04-30",{"date":81,"type":82},"2026-05-06","ACTUAL",{"date":84,"type":61},"2026-05",{"date":86,"type":61},"2029-12-31",{"name":5,"class":6}]