[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biliary-obstruction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biliary-obstruction":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,51,76,105,120,155,185,210,237],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100054303","12-mm-partial-covered-versus-bare-self-expandable-metallic-stents-for-malignant-distal-biliary-obstruction-100054303",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":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Malignant Distal Biliary Obstruction","Malignant Biliary Obstruction","Biliary Obstruction",[31,32,33,34,35,36,37],"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","RECRUITING","2026-07-10",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":42},"2026-05-27",{"date":46,"type":21},"2029-12-31",{"name":48,"class":49},"Chung-Ang University Hospital","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100433876","unity-b-a-prospective-multicentric-single-arm-study-to-evaluate-the-safety-and-efficacy-of-the-unity-b-biodegradable-balloon-expandable-biliary-stent-system-in-subjects-with-biliary-strictures-100433876","NCT04929821","UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures","Inclusion Criteria:\n\n* 1\\) A subject with a biliary stricture may be entered into the study with: at least one of the following:\n* Benign fibrotic distal bile duct obstruction\n* Duct occlusion caused by cholelithiasis\n* A benign fibrotic distal obstruction of the Common Bile Duct (CBD), demonstrated by presence of a stenosis on magnetic resonance cholangiopancreatography (MRCP) and\u002For ERCP with proximal ductal dilation and cholestatic liver enzymes levels\n* Ductal anastomotic strictures\n* Malignant Biliary stricture at least 1 cm distal to the hilum as well as periampullary hilar strictures not involving the papilla.\n* Neoplasm diagnosed on clinical and imaging findings\n* Post-ERCP pancreatitis\n* Obstructive jaundice with evidence of pruritus, tea color urine and pale stool\n* Abnormal Bilirubin rate or\n* A planned exchange of plastic stents previously placed for management of symptomatic biliary stricture or\n* A previous Percutaneous Transhepatic Biliary Drainage (PTBD) for management of symptomatic biliary stricture 2) Age ≥ 18 years old\n\nExclusion Criteria:\n\nPatients, male or female, presenting with the following criteria may be included:\n\n1. Subject is unwilling to comply with the follow-up schedule\n2. Life expectancy \\\u003C 12 m,\n3. Inability to pass a guidewire through stricture\n4. Contra-indication for endoscopy or interventional radiology\n5. History of allergic reactions to one of the compounds of investigational product.\n6. Subject is unable or refuses to give informed consent\n7. Subject is pregnant or breastfeeding\n8. Patient under tutorship\n9. Currently participating in another trial before reaching first endpoint.\n10. Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma\n11. Patient need additional biliary stenting with another device than the study device.\n\n    \\-","18 Years",{"count":59,"type":21},100,[24],"STUDY TYPE: Feasibility study STUDY DESIGN: Prospective, multicenter, single-arm, open-label PRIMARY OBJECTIVE The primary objective is to assess safety of the UNITY Balloon-expandable Biodegradable Biliary Stent System SECONDARY OBJECTIVES Clinical \u002FTechnical \u002FProcedural success, Quality of Life improvement, biodegradation rate",[29,63,64],"Bile Duct Stricture","Bile Duct Diseases","2026-06-16",{"date":67,"type":42},"2026-06-17",{"date":69,"type":42},"2017-10-16",{"date":71,"type":21},"2026-07",{"name":73,"class":74},"QualiMed Innovative Medizinprodukte GmbH","INDUSTRY",6,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":103,"locationsCount":50},"100643432","sedation-methods-in-percutaneous-transhepatic-biliary-drainage-procedure-quality-and-recovery-100643432","NCT07640243","Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery","Evaluation of Sedation Methods Used in Percutaneous Transhepatic Biliary Drainage Procedures in Terms of Procedure Quality, Recovery Time, and Side Effects","Inclusion Criteria:\n\n* Scheduled for elective percutaneous transhepatic biliary drainage (PTBD) and\u002For biliary stenting\n* ASA physical status II-IV\n* Fasting time of at least 6 hours prior to the procedure\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Inability to provide informed consent or to complete study assessments (e.g., Ramsay Sedation Scale, FRAIL scale, Numeric Rating Scale)\n* Clinical diagnosis of Alzheimer's Disease\n* Clinical diagnosis of demantia\n* Known allergy or hypersensitivity to propofol, remifentanil, ketamine, ondansetron, or deksketoprofen\n* Grade 3-4 aortic, mitral, or tricuspid valve disease\n* Advanced or decompensated heart failure (ejection fraction \\\u003C25%)\n* Emergency procedures\n* Refusal to participate in the study",{"count":84,"type":21},98,[24],"This prospective, randomized, single-center study aims to evaluate and compare two different sedation and analgesia regimens used during percutaneous transhepatic biliary drainage (PTBD) procedures. A total of 96 adult patients undergoing elective PTBD or biliary stenting will be randomized to receive either propofol-remifentanil or propofol-ketamine sedation. The primary outcome is recovery time assessed using the Modified Aldrete Score. Secondary outcomes include procedure quality, pain scores, patient and operator satisfaction, hemodynamic stability, and the incidence of sedation-related adverse events. The study is designed to determine the optimal sedation strategy for PTBD, particularly in fragile and elderly patient populations.",[88,29,89,90],"Fragility","Cholangitis","Malignancy",[92,93,94,95,96],"FRAGILITY","Percutaneous Transhepatic Biliary Drainage","SEDATION","KETAMINE","REMİFENTANIL","2026-06-08",{"date":99,"type":42},"2026-06-10",{"date":101,"type":42},"2026-02-01",{"date":99,"type":21},{"name":104,"class":49},"Ankara City Hospital Bilkent",{"id":106,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":25,"conditions":109,"keywords":110,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":118,"locationsCount":4},"100635998",{"count":20,"type":21},[24],[27,28,29],[31,32,33,34,35,36,37],"NOT_YET_RECRUITING","2026-04-30",{"date":114,"type":42},"2026-05-06",{"date":116,"type":21},"2026-05",{"date":46,"type":21},{"name":119,"class":49},"Chung-Ang University Hosptial, Chung-Ang University College of Medicine",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":127,"targetDuration":129,"studyType":130,"phases":4,"briefSummary":131,"conditions":132,"keywords":138,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":50},"100424911","prospective-registry-of-therapeutic-endoscopic-ultrasound-100424911","NCT04813055","Prospective Registry Of Therapeutic EndoscopiC ulTrasound","PROTECT","Inclusion Criteria:\n\n* subjects candidate to therapeutic EUS (T-EUS) procedures for any underlying disease\n* subject eligible to T-EUS procedures but undergoing other non-EUS based endoscopic procedures, percutaneous or surgical procedures\n* 18 years old or older\n* able to provide an informed consent to inclusion.\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* inability or unwillingness to sign the informed consent form (ICF)\n* contra-indication for endoscopy or use of fluoroscopy",{"count":128,"type":21},510,"12 Months","OBSERVATIONAL","This registry aims to analyze long-term outcomes of therapeutic EUS (T-EUS) procedures, as well as to describe clinical and technical variables potentially predicting clinical success or adverse events, for a better selection of ideal candidates.\n\nThe study also includes standard alternatives to T-EUS procedures for outcomes comparison.",[133,29,134,135,136,137],"Gastric Outlet Obstruction","Acute Pancreatic Fluid Collection","Acute Pancreatitis With Infected Necrosis","Acute Cholecystitis","Chronic Pancreatitis",[139,140,141,142,143,144,145],"Endoscopic ultrasound","Therapeutic EUS","Interventional EUS","Biliary Drainage","Gastro-jejunostomy","Gallbladder Drainage","Endoscopy","2026-04-10",{"date":148,"type":42},"2026-04-13",{"date":150,"type":42},"2020-12-01",{"date":152,"type":21},"2026-12-31",{"name":154,"class":49},"Paolo Giorgio Arcidiacono, MD",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":166,"conditions":167,"keywords":172,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":50},"100624273","phase-2-comparative-efficacy-of-intraductal-antibiotic-during-ercp-in-acute-cholangitis-100624273","NCT07407491","Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis","Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* The patients diagnosed with mild and moderate acute cholangitis based on TG 18\n* Planned for ERCP within 48 hours\n* 18 years old and above\n\nExclusion Criteria:\n\n* Severe acute cholangitis\n* History of antibiotic hypersensitivity\n* Receiving cancer chemotherapy, steroids, or immunosuppressive agents\n* Concomitant infections\n* Recent biliary interventions such as percutaneous transhepatic biliary drainage (PTBD) within last 3 months\n* Known or suspected perforated tympanic membrane, myasthenia gravis",{"count":163,"type":21},172,[165],"PHASE2","Does intraductal administration of antibiotics during endoscopic retrograde cholangiopancreatography (ERCP), in addition to standard systemic antibiotic therapy, improve clinical outcomes in patients with acute cholangitis compared with standard systemic antibiotic therapy alone?",[168,169,29,170,171],"Acute Cholangitis","Biliary Tract Infection","Choledocholithiasis","Malignant Biliary Stricture",[168,173,174,175,170],"ERCP","Intraductal antibiotics","Biliary tract infection","2026-02-05",{"date":178,"type":42},"2026-02-12",{"date":180,"type":42},"2024-07-09",{"date":182,"type":21},"2026-07-08",{"name":184,"class":49},"National University of Malaysia",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":208,"locationsCount":50},"100563758","safety-and-efficacy-of-mechanical-versus-electrocautery-dilator-for-eus-guided-biliary-drainage-med-bd-100563758","NCT06620328","Safety and Efficacy of Mechanical Versus Electrocautery Dilator for EUS-guided Biliary Drainage (MED-BD)","Safety and Efficacy of Mechanical Versus Electrocautery Dilator for EUS-guided Biliary Drainage: A Prospective Randomized Controlled Trial","MED-BD","Inclusion Criteria:\n\n* Failed ERCP\n* The papilla is inaccessible owing to a surgically altered anatomy or gastric outlet obstruction\n* Contraindications for PTCD such as ascites and possibility of self-tube removal\n\nExclusion Criteria:\n\n* Patients younger than 18 years old\n* Cancer infiltration of the gastric\u002Fduodenal wall within the planned puncture route\n* Patients with uncorrectable coagulopathy\n* Patients with unmanageable ascites\n* Patients with serious comorbidities that prohibited endoscopic management\n* Patients with pregnancy\n* Patients who cannot or refuse to provide informed consent",{"count":194,"type":21},64,[24],"The purpose of this study is to investigate the likelihood of post-dilation bleeding using mechanical or electrocautery dilation. We hypothesized that the risk of bleeding is lower in the mechanical group.",[29],[139,199,200,201,141],"Biliary drainage","Mechanical dilator","Electrocautery dilator","2026-01-11",{"date":204,"type":42},"2026-01-13",{"date":206,"type":42},"2025-07-03",{"date":152,"type":21},{"name":209,"class":49},"National Taiwan University Hospital",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":222,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":50},"100538152","prevention-of-acute-cholecystitis-with-etgbd-100538152","NCT06287112","Prevention of Acute Cholecystitis With ETGBD","Efficacy of ETGBD Parallel Insertion With Fully Covered Self-expandable Metal Stent for Preventing Acute Cholecystitis in Patients With Low Cystic Duct Insertion","Inclusion Criteria:\n\n1. Adults 19 years of age or older\n2. Patients requiring endoscopic retrograde cholangiography and drainage for therapeutic purposes.\n3. Patients with imaging (CT, Cholangiogram) confirmed confluence of the cystic duct with the distal third of the common bile duct.\n4. Patients who have voluntary informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients who have undergone percutaneous\u002Fsurgical bile duct or gallbladder drainage prior to study enrollment.\n* Patients with anatomic deformity of the upper gastrointestinal tract after gastric or hepatobiliary surgery\n* Patients with concomitant gastric\u002Fduodenal obstruction\n* Patients with confirmed or suspected cystic duct obstruction on imaging studies\n* Patients with acute cholecystitis, acute pancreatitis\n* Patients who underwent cholecystectomy\n* Patients with a life expectancy of less than 3 months\n* Patients who are otherwise unable to undergo endoscopic retrograde cholangiopancreatography",{"count":218,"type":21},35,[24],"The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion.\n\nIn this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility.",[29,136],[223,224,225,226,227],"Malignant biliary obstruction","Fully covered self expandable metal stent","Endoscopic transpapillary gallbladder drainage","Preventive Effect","Acute cholecystitis","2025-02-18",{"date":230,"type":42},"2025-02-20",{"date":232,"type":42},"2024-06-20",{"date":234,"type":21},"2027-03-30",{"name":236,"class":49},"Seoul National University Hospital",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":50},"100579149","gallbladder-stenting-in-fc-sems-100579149","NCT06820541","Gallbladder Stenting in FC-SEMS","Prophylactic Endoscopic Transpapillary Gallbladder Drainage to Prevent Post-ERCP Cholecystitis After Covered Metal Stent Placement for Distal Biliary Obstruction: a Randomized Controlled Study","Inclusion Criteria:\n\n* Adult patients\n* Signed informed consent\n* Patients requiring covered metal stent placement for managing MBO\n* High-risk of post-endoscopic cholangiopancreatography acute cholecystitis according to the following criteria:\n* tumor involvement of the cystic duct orifice confirmed on magnetic resonance imaging, computed tomography, endoscopic ultrasound, or at endoscopic cholangiopancreatography;\n* presence of at least 2 of the following:\n\n  1. gallbladder stones;\n  2. CBD diameter ≤ 10 mm;\n  3. intraprocedural gallbladder opacification;\n  4. cystic duct orifice at risk of being covered by the fully-covered stent\n\nExclusion Criteria:\n\n* History of cholecystectomy\n* Endoscopic retrograde cholangiopancreatography not feasible for duodenal stenosis or failed biliary cannulation\n* Patients with previous gallbladder drainage\n* Acute cholecystitis is already present based on the Tokyo guidelines",{"count":245,"type":21},80,[24],"The goal of this randomized controlled trial is to determine whether primary prophylaxis with transpapillary gallbladder drainage prevents acute cholecystitis after fully-covered self-expandable metal stents placement during endoscopic retrograde cholangiopancreatography for malignant distal biliary obstruction in patients at higher risk of post-endoscopic retrograde cholangiopancreatography acute cholecystitis.\n\nThe main question it aims to answer is:\n\nDoes prophylactic transpapillary gallbladder drainage reduce the rate of post-endoscopic retrograde cholangiopancreatography acute cholecystitis in high-risk patients? Researchers will compare patients who undergo transpapillary gallbladder drainage to patients without transpapillary gallbladder drainage to see if transpapillary gallbladder drainage reduces the rate of acute cholecystitis.\n\nParticipants will:\n\n1. receive or not transpapillary gallbladder drainage before fully-covered self-expandable metal stents placement\n2. will be followed up at one, three, and six months to ascertain the onset of acute cholecystitis",[29,136],"2025-02-06",{"date":251,"type":42},"2025-02-11",{"date":253,"type":21},"2025-03-01",{"date":255,"type":21},"2026-10-01",{"name":257,"class":49},"Azienda Ospedaliera Universitaria Integrata Verona"]