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EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)
Sponsor: Hospital Universitari de Bellvitge
Summary
The aim of this clinical trial is to evaluate the biliary drainage technical failure rate and/or the postprocedure acute pancreatitis rate between EUS-CDS vs ERCP procedures in patients with distal malignant biliary obstruction.
Official title: Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction: An Open-label, Multicenter Randomized Trial (CARPEDIEM Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-05-06
Completion Date
2028-05-06
Last Updated
2025-07-29
Healthy Volunteers
No
Interventions
Endoscopic biliary drainage
Decompression of the bile duct by endoscopic aproach.
Self-expandable metallic stent (SEMS)
Self-expandable metallic stent (SEMS) deployment: Covering: Uncovered or Partially Covered. Non covered if gallbladder is present. Size: 10x40mm or 10x60mm or 10x80mm.
Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment: LAMS size: 6x8mm or 8x8mm. Consider 10x10mm if bile duct \> 18mm. DPPS size: 7Fr x 3-7cm.
Locations (10)
Hospital General Universitario Dr. Balmis
Alicante, Alicante, Spain
Hospital General Universitario de Castellón
Castellon, Castellón, Spain
Hospital de Sant Pau i de la Santa Creu
Barcelona, Catalonia, Spain
Hospital Universitari de Bellvitge
Hospitalet de Llobregat, Barcelona, Catalonia, Spain
Hospital Mútua de Terrassa
Terrassa, Catalonia, Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Salamanca, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain