EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIE… (NCT06653192) | Clinical Trial Compass
SuspendedNot Applicable
EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)
Stopped: Class I Recall (Feb 2026): Boston Scientific issued a global recall for specific lots of AXIOS 6x8mm and 8x8mm due to reports of deployment and expansion failure during the procedure.
Spain120 participantsStarted 2025-05-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
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…