protocolSection identificationModule nctId: NCT06375954, orgStudyIdInfo id: CARPEDIEM-2, briefTitle: EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari de Bellvitge, class: OTHER, collaborators name: Hospital Mutua de Terrassa, collaborators name: Hospital Clínico Universitario de Valencia, collaborators name: Hospital General Universitario de Alicante, collaborators name: Hospital Universitario Ramon y Cajal, collaborators name: Hospital General Universitario de Castellón, collaborators name: Hospital Álvaro Cunqueiro, collaborators name: Complejo Hospitalario Universitario de Santiago, collaborators name: University Hospital Virgen de las Nieves, collaborators name: Complejo Hospitalario de Navarra, collaborators name: Hospital de Sant Pau, collaborators name: University of Salamanca, descriptionModule briefSummary: 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., conditionsModule conditions: Malignant Biliary Obstruction, conditions: Pancreatic Cancer, conditions: Biliary Tract Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic biliary drainage, interventions name: Self-expandable metallic stent (SEMS), interventions name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS), outcomesModule primaryOutcomes measure: Delay in days between endoscopic biliary drainage and chemotherapy treatment start, secondaryOutcomes measure: Technical success, secondaryOutcomes measure: Clinical success, secondaryOutcomes measure: AE - biliary drainage, secondaryOutcomes measure: AE - surgery, secondaryOutcomes measure: Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitari de Bellvitge, city: L'Hospitalet de Llobregat, state: Barcelona, zip: 08907, country: Spain, contacts name: Joan B Gornals, MD, PhD, role: CONTACT, phone: + 34 93 260 7682, phoneExt: 2624, email: jgornals@bellvitgehospital.cat, contacts name: Maria Puigcerver-Mas, MD, role: CONTACT, phone: +34 687332007, email: mariapuigcervermas@gmail.com, contacts name: Julia Escuer, MD, role: SUB_INVESTIGATOR, contacts name: Sandra Maisterra, MD, role: SUB_INVESTIGATOR, contacts name: Julio G Velasquez-Rodriguez, MD, role: SUB_INVESTIGATOR, contacts name: Albert Garcia-Sumalla, MD, role: SUB_INVESTIGATOR, contacts name: Daniel Luna-Rodriguez, MD, role: SUB_INVESTIGATOR, contacts name: Berta Laquente, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Juli Busquets, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Carme Loras, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Juan J Vila, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jose Lariño, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: VIcente Sanchiz, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jose R Aparicio, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Eduardo Redondo, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Charly Guarner-Argente, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Antonio Rodriguez D'Jesus, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alberto Alvarez, MD, pHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.35967, lon: 2.10028, hasResults: False