[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544981":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":44,"locations":55,"responsibleParty":106,"collaborators":109,"id":132,"slug":34,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":34,"eligibilityCriteria":137,"healthyVolunteers":133,"sex":138,"minAge":139,"maxAge":34,"enrollmentInfo":140,"targetDuration":34,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":158,"whyStopped":34,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Hospital Universitari de Bellvitge","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"ERCP with SEMS","ACTIVE_COMPARATOR","Endoscopic retrograde cholangiopancreatography (ERCP) with deployment of a self-expandable metallic stent (SEMS). Gold standard in malignant distal biliary obstruction (MDBO) in current practice.\n\nERCP technique: Cannulation with papillotome (advanced cannulation techniques are allowed). Sphincterotomy. Self-expandable metallic stent (SEMS) deployment.",[13,14],"Procedure: Endoscopic biliary drainage","Device: Self-expandable metallic stent (SEMS)",{"label":16,"type":17,"description":18,"interventionNames":19},"EUS-CDS with LAMS-Pigtail","EXPERIMENTAL","Echoendoscopy-guided Choledochoduodenostomy (EUS-CDS) with deployment of a lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent throug LAMS.\n\nEUS-CDS technique: Diagnostic EUS. Classic or free-hand with preloaded guidewire choledochoduodenostomy with LAMS. Pneumatic dilation whithin LAMS is allowed. In case of bile duct \\\u003C 15mm is mandatory the 'push' technique. Deployment of a pigtail coaxial to LAMS.",[13,20],"Device: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Endoscopic biliary drainage","Decompression of the bile duct by endoscopic aproach.",[9,16],[28],"Biliary drainage",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","Self-expandable metallic stent (SEMS)","Self-expandable metallic stent (SEMS) deployment:\n\n* Covering: Uncovered or Partially Covered. Non covered if gallbladder is present.\n* Size: 10x40mm or 10x60mm or 10x80mm.",[9],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)","Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment:\n\n* LAMS size: 6x8mm or 8x8mm. Consider 10x10mm if bile duct \\> 18mm.\n* DPPS size: 7Fr x 3-7cm.",[16],[40],{"name":41,"affiliation":42,"role":43},"Joan B Gornals, PhD","Hospital Universitari de Bellvitge, SEED","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":34,"email":49},"Maria Puigcerver-Mas, MD,","CONTACT","+34 687332007","mariapuigcervermas@gmail.com",{"name":51,"role":47,"phone":52,"phoneExt":53,"email":54},"Joan B Gornals, MD,PhD","+34 932607682","2624","jgornals@bellvitgehospital.cat",[56],{"facility":5,"status":34,"city":57,"state":58,"zip":59,"country":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"L'Hospitalet de Llobregat","Barcelona","08907","Spain",{"type":62,"coordinates":63},"Point",[64,65],2.10028,41.35967,{"lat":65,"lon":64},[68,71,73,76,78,80,82,84,86,88,90,92,94,96,98,100,102,104],{"name":69,"role":47,"phone":70,"phoneExt":53,"email":54},"Joan B Gornals, MD, PhD","+ 34 93 260 7682",{"name":72,"role":47,"phone":48,"phoneExt":34,"email":49},"Maria Puigcerver-Mas, MD",{"name":74,"role":75,"phone":34,"phoneExt":34,"email":34},"Julia Escuer, MD","SUB_INVESTIGATOR",{"name":77,"role":75,"phone":34,"phoneExt":34,"email":34},"Sandra Maisterra, MD",{"name":79,"role":75,"phone":34,"phoneExt":34,"email":34},"Julio G Velasquez-Rodriguez, MD",{"name":81,"role":75,"phone":34,"phoneExt":34,"email":34},"Albert Garcia-Sumalla, MD",{"name":83,"role":75,"phone":34,"phoneExt":34,"email":34},"Daniel Luna-Rodriguez, MD",{"name":85,"role":75,"phone":34,"phoneExt":34,"email":34},"Berta Laquente, MD, PhD",{"name":87,"role":75,"phone":34,"phoneExt":34,"email":34},"Juli Busquets, MD, PhD",{"name":89,"role":43,"phone":34,"phoneExt":34,"email":34},"Carme Loras, MD, PhD",{"name":91,"role":43,"phone":34,"phoneExt":34,"email":34},"Juan J Vila, MD, PhD",{"name":93,"role":43,"phone":34,"phoneExt":34,"email":34},"Jose Lariño, MD, PhD",{"name":95,"role":43,"phone":34,"phoneExt":34,"email":34},"VIcente Sanchiz, MD, PhD",{"name":97,"role":43,"phone":34,"phoneExt":34,"email":34},"Jose R Aparicio, MD, PhD",{"name":99,"role":43,"phone":34,"phoneExt":34,"email":34},"Eduardo Redondo, MD, PhD",{"name":101,"role":43,"phone":34,"phoneExt":34,"email":34},"Charly Guarner-Argente, MD, PhD",{"name":103,"role":43,"phone":34,"phoneExt":34,"email":34},"Antonio Rodriguez D'Jesus, MD, PhD",{"name":105,"role":43,"phone":34,"phoneExt":34,"email":34},"Alberto Alvarez, MD, pHD",{"type":43,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Joan B Gornals","PhD and Head of Interventional Endoscopy Unit",[110,112,114,116,118,120,122,124,126,128,130],{"name":111,"class":6},"Hospital Mutua de Terrassa",{"name":113,"class":6},"Hospital Clínico Universitario de Valencia",{"name":115,"class":6},"Hospital General Universitario de Alicante",{"name":117,"class":6},"Hospital Universitario Ramon y Cajal",{"name":119,"class":6},"Hospital General Universitario de Castellón",{"name":121,"class":6},"Hospital Álvaro Cunqueiro",{"name":123,"class":6},"Complejo Hospitalario Universitario de Santiago",{"name":125,"class":6},"University Hospital Virgen de las Nieves",{"name":127,"class":6},"Complejo Hospitalario de Navarra",{"name":129,"class":6},"Hospital de Sant Pau",{"name":131,"class":6},"University of Salamanca","100544981",false,"NCT06375954","EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)","Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction in Borderline Disease: An Open-label, Multicenter Randomized Trial (CARPEDIEM-2 Trial)","Inclusion Criteria:\n\n* Malignant distal biliary obstruction diagnosed in patient considered BORDERLINE with biliary drainage indication: i) impaired hepatic enzymes (including hyperbilirubinemia) x3 times upper the superior normal value. ii) Radiologic singns of extrahepatic bile duct obstruction with presence of retrograde dilatation, of at least 12-mm axial diameter.\n* Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histological confirmation is not mandatory)\n* Patient capable of understanding and\u002For singning the informed consent.\n* Patient who understands the type of study and will comply with all follow-up tests throughout its duration\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Severe coagulation disorder: INR \\> 1.5 non correctable with plasma administration and\u002For platelet count \\\u003C 50.000\u002Fmm3.\n* Distal malignant biliary strictures in patients considered directly resectable, non-surgical, unresectable, or palliative\n* Benign or uncertain etiology of biliary strictures or strictures located proximally or in close proximity to the hilum.\n* Patients with prior biliary stents or other biliary drainages (e.g., PTCD).\n* Altered intestinal anatomy due to prior surgery that prevents or hinders papillary access (e.g., gastric bypass, Billroth II, duodenal switch, Roux-en-Y).\n* Stenosis in the antral or duodenal region that prevents access to the duodenum and reaching the papilla.\n* Situations that do not allow for upper gastrointestinal endoscopy (e.g., esophageal stricture).\n* Patients with functional diversity, who lack the capacity to understand the nature and potential consequences of the study, except when a legal representative is available.\n* Patients incapable of maintaining follow-up appointments (lack of adherence).\n* Lack of informed consent.","ALL","18 Years",{"count":141,"type":142},96,"ESTIMATED","INTERVENTIONAL",[145],"NA","The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction.",[148,149,150],"Malignant Biliary Obstruction","Pancreatic Cancer","Biliary Tract Neoplasms",[152,153,154,155,156,157],"Choledochoduodenostomy","Therapeutic endoscopy","Biliary Drainage","Lumen apposing metal stent","ERCP","Biliopancreatic malignancy","NOT_YET_RECRUITING","2024-04-18",{"date":161,"type":162},"2024-04-19","ACTUAL",{"date":164,"type":142},"2024-05-01",{"date":166,"type":142},"2027-05-01",{"name":5,"class":6},1]