Endoscopic Ultrasound-guided Choledoco duodenostomy vs Endoscopic Retrograde Cholangiopancreatography in malignant distal biliary obstruction to prevent post procedural pancreatitis: a randomized controlled trial

Aims Post-procedural pancreatitis (PPP) is the most common adverse event associated with endoscopic retrograde cholangiopancreatography (ERCP). Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) using a lumen-apposing metal stent is emerging as a promising approach for managing malignant distal biliary obstruction (MDBO), offering the potential to lower the risk of PPP. We compared the outcomes of EUS-CDS with ERCP when used as the primary modality for biliary decompression.

Methods This was a multicenter randomized controlled study, enrolling consecutive patients admitted for obstructive jaundice due to malignant distal biliary obstruction with dilated common bile duct (CBD >15mm). Patients were randomly allocated to receive EUS-CDS or ERCP for primary biliary drainage. This was a superiority trial with post-procedural acute pancreatitis (abdominal pain, elevation in pancreatic enzymes, and hospitalisation) as primary outcome. Other outcomes included technical success, clinical success, adverse events, 6-months stent patency rate, and overall survival. Analyses were performed according to intention-to-treat principles. This trial is registered with ClinicalTrials.gov (NCT04099862).

Results Between April 2021 and October 2023, 220 patients were enrolled in the study (EUS-CDS group: 111; ERCP group: 109). EUS-CDS group showed a lower risk for post-procedural acute pancreatitis (1.8% in EUS-CDS group vs 7.3% in ERCP group; RR: 0.25, 95%CI 0.07-0.88). Technical success was achieved in 94.6% in EUS-CDS group vs 78.9% ERCP group (p value:<0.001), in a mean procedural time of 13.5+11.6 minutes, and 24.7+14.9 minutes, respectively (p value:<0.001). No differences were found in other adverse events, clinical success, stent patency, or overall mortality [1] [2] [3] [4].

Conclusions EUS-CDS is superior to ERCP in reducing post-procedural acute pancreatitis risk, also showing improved technical success, and comparable clinical efficacy. These results support the use of EUS-CDS as the primary approach in patients with dilated CBD.

Publication History

Article published online:
27 March 2025

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