protocolSection identificationModule nctId: NCT06375967, orgStudyIdInfo id: CARPEGIEM, briefTitle: EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial), acronym: CARPEGIEM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari de Bellvitge, class: OTHER, collaborators name: Hospital Clínico Universitario de Valencia, collaborators name: Hospital General Universitario de Alicante, collaborators name: Hospital Mutua de Terrassa, collaborators name: Hospital Universitario Ramon y Cajal, collaborators name: Hospital General Universitario de Castellón, collaborators name: Complejo Hospitalario de Navarra, collaborators name: University Hospital Virgen de las Nieves, collaborators name: Hospital de Sant Pau, collaborators name: University of Salamanca, collaborators name: Complejo Hospitalario Universitario de Santiago, collaborators name: Complejo Hospitalario Universitario de Vigo, descriptionModule briefSummary: The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients., conditionsModule conditions: Malignant Biliary Obstruction, conditions: Biliary Tract Neoplasms, conditions: Pancreatic Cancer Non-resectable, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic biliary drainage, interventions name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS), interventions name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS), outcomesModule primaryOutcomes measure: SAFETY (ADVERSE EVENTS), primaryOutcomes measure: Recurrent biliary obstruction, secondaryOutcomes measure: CLINICAL SUCCESS, secondaryOutcomes measure: TECHNICAL SUCCESS, secondaryOutcomes measure: BILIARY REINTERVENTIONS (BRI), secondaryOutcomes measure: HOSPITAL STAY, secondaryOutcomes measure: MORTALITY, secondaryOutcomes measure: COST ANALYSIS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 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, PhD, role: CONTACT, phone: +34 93 260 76 82, phoneExt: 2624, email: jgornals@bellvitgehospital.cat, contacts name: Julia Escuer Turu, MD, role: CONTACT, phone: +34 618 27 28 24, email: jescuer@bellvitgehospital.cat, contacts name: Maria Puigcerver Mas, MD, role: SUB_INVESTIGATOR, contacts name: Sandra Maisterra, MD, role: SUB_INVESTIGATOR, contacts name: Albert Garcia-Sumalla, MD, role: SUB_INVESTIGATOR, contacts name: Julio G Velasquez-Rodriguez, MD, role: SUB_INVESTIGATOR, contacts name: Daniel Luna-Rodriguez, 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: Juan J Vila, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jose R Aparicio, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jose Lariño, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Rafa Pedraza, 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, contacts name: Vicente Sanchiz, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.35967, lon: 2.10028, hasResults: False