protocolSection identificationModule nctId: NCT06375928, orgStudyIdInfo id: CARPEDIEM-1, briefTitle: EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2026-05-01, 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 surgery in patients with resectable distal malignant biliary obstruction., conditionsModule conditions: Malignant Biliary Obstruction, conditions: Pancreatic Cancer Resectable, conditions: Biliary Tract Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 44, 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 cephalic duodenopancreatectomy (CDP), secondaryOutcomes measure: Technical success, secondaryOutcomes measure: Clinical success, secondaryOutcomes measure: AE - biliary drainage, secondaryOutcomes measure: AE - surgery, 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, Catalonia, zip: 08907, country: Spain, contacts name: Joan B Gornals, MD, PhD, role: CONTACT, phone: +34 93 260 76 82, 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-Turu, MD, role: SUB_INVESTIGATOR, contacts name: Daniel Luna Rodriguez, MD, role: SUB_INVESTIGATOR, contacts name: Albert Sumalla, MD, role: SUB_INVESTIGATOR, contacts name: Berta Laquente, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Juli Busquets, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Julio Velasquez Rodriguez, MD, role: SUB_INVESTIGATOR, contacts name: Sandra Maisterra, MD, role: SUB_INVESTIGATOR, contacts name: Carme Loras, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Charly Guarner Argente, MD, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jose Lariño, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Rafael Pedraza, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jose Ramon Aparicio, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Vicente Sanchiz, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Eduardo Redondo, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Juan J Vila, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.35967, lon: 2.10028, hasResults: False