EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)

Who can take part

• Malignant distal biliary obstruction diagnosed in patient considered RESECTABLE or POTENTIALLY RESECTABLE/BORDERLINE with biliary drainage indication: i) impaired hepatic enzymes (including hyperbilirubinemia) x3 times upper the superior normal value. ii) Radiologic singns of extrahepatic bile duct obstruction with presence of retrograde dilatation, of at least 12-mm axial diameter
• Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histological confirmation is not mandatory)
• Patient capable of understanding and/or singning the informed consent
• Patient who understands the type of study and will comply with all follow-up tests throughout its duration

Who cannot take part

• Patients with prior biliary stents or other biliary drainages (e.g., PTCD)
• Altered intestinal anatomy due to prior surgery that prevents or hinders papillary access (e.g., gastric bypass, Billroth II, duodenal switch, Roux-en-Y)
• Distal malignant biliary strictures in patients considered directly resectable, non-surgical, unresectable, or palliative
• Severe coagulation disorder: INR > 1.5 non correctable with plasma administration and/or platelet count < 50.000/mm3
• Pregnancy or lactation
• Benign or uncertain etiology of biliary strictures or strictures located proximally or in close proximity to the hilum
• Stenosis in the antral or duodenal region that prevents access to the duodenum and reaching the papilla
• Situations that do not allow for upper gastrointestinal endoscopy (e.g., esophageal stricture)
• Patients with functional diversity, who lack the capacity to understand the nature and potential consequences of the study, except when a legal representative is available
• Patients incapable of maintaining follow-up appointments (lack of adherence)
• Lack of informed consent