EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)
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)
Hospital Universitari de Bellvitge
120 participants
May 6, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Decompression of the bile duct by endoscopic aproach.
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) 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)
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NCT06653192