Pancreas

Gastroenterology. 2026;170(3):584-594

Anderloni A, Spadaccini M, Binda C, Mauro A, Stigliano S, Carrozza L, Colombo M, Mazza S, Coluccio C, Amato A, Andreozzi M, Rizzo GEM, Facciorusso A, Radaelli F, Carrara S, Mangiavillano B, Di Matteo FM, Tarantino I, Hassan C, Repici A, Fugazza A, Fabbri C

Endoscopic ultrasound-guided choledochoduodenostomy vs. endoscopic retrograde cholangiopancreatography in malignant distal biliary obstruction to prevent postprocedural pancreatitis: A randomized trial


Background and aims: Postprocedural pancreatitis is the most common adverse event (AE) 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, offering the potential to lower the risk of postprocedural pancreatitis.
Methods: This was a multicenter randomized study, enrolling consecutive patients admitted for obstructive jaundice due to malignant distal biliary obstruction with dilated common bile duct (≥ 15 mm). Patients were randomly allocated to receive EUS-CDS or ERCP for primary biliary drainage. This was a superiority trial with postprocedural acute pancreatitis as primary outcome. Other outcomes included technical success, clinical success, AEs, 6-month stent patency rate, and overall survival. Analyses were performed according to intention-to-treat principles.
Results: Between April 2021 and October 2023, 220 patients were enrolled in the study (EUS-CDS, 111; ERCP, 109). EUS-CDS group showed a lower risk for postprocedural acute pancreatitis (1.8% in EUS-CDS vs. 7.3% in ERCP; relative risk [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 < 0.001), in a mean procedural time of 13.5 ± 11.6 minutes and 24.7 ± 14.9 minutes, respectively (p < 0.001). No differences were found in other AEs (19.8% in EUS-CDS vs. 21.1% in ERCP; RR = 0.94; 95% CI: 0.56–1.58), clinical success, stent patency, or overall mortality.

Conclusions: EUS-CDS is superior to ERCP in reducing postprocedural acute pancreatitis risk. However, the overall risk of AEs was not significantly different and warrants further investigation. Additionally, EUS-CDS showed improved technical success and comparable clinical efficacy. These results support a potential role of EUS-CDS as primary approach in selected patients with dilated common bile duct.

M. Spadaccini, Humanitas Clinical and Research Center–IRCCS and Humanitas University, Rozzano, Milan, Italy, e-mail: marco.spadaccini@humanitas.it

DOI:  10.1053/j.gastro.2025.09.003

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