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

Phase

SUSPENDED

Status

120

Enrollment

OTHER

Sponsor class

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.

Conditions

Malignant Biliary Obstruction
Pancreatic Cancer
Biliary Tract Neoplasms

Interventions

PROCEDURE: Endoscopic biliary drainage
DEVICE: Self-expandable metallic stent (SEMS)
DEVICE: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)

Sponsor

Hospital Universitari de Bellvitge

Collaborators

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