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

Exclusion Criteria

• •Pregnancy or lactation.
• •Severe coagulation disorder: INR \> 1.5 non correctable with plasma administration and/or platelet count \< 50.000/mm3.
• •Distal malignant biliary strictures in patients considered directly resectable, non-surgical, unresectable, or palliative
• •Benign or uncertain etiology of biliary strictures or strictures located proximally or in close proximity to the hilum.
• •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).
• •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.