Pancreatic Cancer Research

Clinical trialNASuspended

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)

NCT06653192↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Stopped earlyClass 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. (Other)
Phase
NA
Status
Suspended
Study type
Interventional
Start
6 May 2025
Expected end
6 May 2028
Enrollment
120 participants
Sites
10
Primary outcomes
Postprocedure surgical challenges rate
Sponsor
Other
Results posted
No
Last update
6 May 2026

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Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) has been extended as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). However, there are clinical trials which have compared it with ERCP as a first line treatment for MDBO in palliative patients, showing similar clinical and technical success and adverse events (AEs) rate between both techniques. Data about the benefit of this techique in potentially surgical patients is still limited. Recent retrospective study (Janet J et al, Ann Surg Oncol 2023) and two recent meta-analysis (Barbosa E et al, GIE 2024; Gopakumar H et al, AM J Gastr 2024; both with \> 500 cases) found that EUS-CDS group had significantly less technical failure rate and less postprocedure pancreatitis rate. Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing those rates (technical failure, postprocedure pancreatitis) when compared to ERCP in MDBO in potentially surgical patients with resectable and borderline disease.

Papers 5