Endoscopic Ultrasound-Guided Choledochoduodenostomy vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction to Prevent Postprocedural Pancreatitis: A Randomized Trial.

BACKGROUND & 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, 0.25; 95% confidence interval, 0.07-0.88). Technical success was achieved in 94.6% in EUS-CDS group vs 78.9% ERCP group (P < .001), in a mean procedural time of 13.5 ± 11.6 minutes and 24.7 ± 14.9 minutes, respectively (P <.001). No differences were found in other AEs (19.8% in EUS-CDS vs 21.1% in ERCP; relative risk, 0.94; 95% confidence interval, 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 (ClinicalTrials.gov, Number: NCT04099862).