[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638664":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":34,"responsibleParty":41,"collaborators":46,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":34,"enrollmentInfo":61,"targetDuration":34,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":78,"whyStopped":34,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":34},{"fullName":5,"class":6},"Soonchunhyang University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"M-FCSEMS group","EXPERIMENTAL","Participants in this arm will undergo endoscopic retrograde cholangiopancreatography (ERCP) with placement of a modified 8-mm fully covered self-expandable metal stent (FCSEMS) for preoperative biliary drainage.",[13],"Device: Modified 8-mm Fully Covered Self-Expandable Metal Stent",{"label":15,"type":16,"description":17,"interventionNames":18},"PS group","ACTIVE_COMPARATOR","Participants in this arm will undergo endoscopic retrograde cholangiopancreatography (ERCP) with placement of a plastic stent (PS) for preoperative biliary drainage.",[19],"Device: Plastic stent",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Modified 8-mm Fully Covered Self-Expandable Metal Stent","A modified non-flared 8-mm fully covered self-expandable metal stent designed for preoperative biliary drainage. The stent features a dumbbell-shaped structure with a narrower central portion to reduce migration, a fully covered membrane to prevent tissue ingrowth, and a retrieval lasso to facilitate removal. It is deployed via ERCP across the malignant biliary stricture.",[9],[27],"M-FCSEMS",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Plastic stent","A conventional 8.5-Fr plastic biliary stent used for preoperative biliary drainage. The stent is placed via ERCP across the malignant biliary stricture and represents the standard treatment option, although it is associated with shorter patency and a higher risk of occlusion compared to metal stents.",[15],[33],"PS",null,[36],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Il Sang Shin, Assistant Professor","CONTACT","+82-10-4658-8794","ilsang.shin@schmc.ac.kr",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":45,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Il Sang Shin","Professor","Soonchunhyang University School of Medicine",[47,49],{"name":48,"class":6},"Samsung Medical Center",{"name":50,"class":6},"Asan Medical Center","100638664","comparison-of-a-short-modified-metal-stent-versus-plastic-stent-as-a-bridge-to-surgery-in-pancreatic-cancer-with-malignant-biliary-obstruction-100638664",false,"NCT07606430","Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction","Multicenter Randomized Trial of a Short Modified 8-mm-diameter Fully Covered Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction","BRIDGE-8","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients with resectable, borderline resectable, or locally advanced pancreatic cancer with distal malignant biliary obstruction requiring endoscopic biliary drainage\n3. Biliary stricture located ≥ 2 cm below the hepatic hilum\n4. Serum bilirubin ≥ 3 mg\u002FdL\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n6. Ability to provide written informed consent\n\nExclusion Criteria:\n\n1. Presence of distant metastasis\n2. Prior biliary stent placement for biliary obstruction\n3. Requirement for duodenal stent placement due to gastric outlet obstruction\n4. Estimated life expectancy \\\u003C 3 months\n5. Inability to undergo ERCP\n6. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study outcomes","ALL","18 Years",{"count":62,"type":63},116,"ESTIMATED","INTERVENTIONAL",[66],"NA","This study is a multicenter, randomized clinical trial designed to compare the effectiveness and safety of a modified 8-mm fully covered self-expandable metal stent (FCSEMS) with a conventional plastic stent for preoperative biliary drainage in patients with pancreatic cancer and malignant biliary obstruction.\n\nIn patients who require biliary drainage before surgery, stent placement is commonly performed using endoscopic retrograde cholangiopancreatography (ERCP). However, the optimal stent type remains uncertain.\n\nParticipants will be randomly assigned to receive either the modified FCSEMS or a plastic stent. The primary objective is to evaluate the rate of stent-related complications requiring reintervention before surgery. Secondary outcomes include stent patency, adverse events, and surgical outcomes.\n\nThe results of this study are expected to help determine the most appropriate stent strategy for patients undergoing surgery for pancreatic cancer.",[69,70],"Pancreatic Cancer","Malignant Biliary Obstruction",[72,73,74,75,76,77],"pancreatic cancer","malignant biliary obstruction","preoperative biliary drainage","ERCP","fully covered self-expandable metal stent","plastic stent","NOT_YET_RECRUITING","2026-05-18",{"date":81,"type":82},"2026-05-26","ACTUAL",{"date":84,"type":63},"2026-05-01",{"date":86,"type":63},"2029-12-31",{"name":5,"class":6}]