Introduction
Endoscopic Ultrasonography (EUS) is increasingly being used in preoperative examinations in pancreatobiliary diseases for Endoscopic retrograde cholangiopancreatography (ERCP). However, it has never been tested in a randomized trial. This study aims to investigate the clinical value of performing EUS prior to ERCP versus performing conventional ERCP alone, focusing on avoiding unnecessary procedures, ensuring treatment concordance, reducing radiation exposure, and preventing complications.
Aims & Methods
In this single-center, parallel-group randomized controlled trial, patients with pancreaticobiliary diseases and a clear indication for ERCP were enrolled. Using a random number table, participants were assigned to either the EUS+ERCP group or the ERCP alone group. The primary outcomes were the rate of avoided unnecessary ERCP and the concordance rate between actual and initially planned interventional strategies. Secondary outcomes included technical success, difficult cannulation, procedure time, radiation dose, and complications.
Results
A total of 208 patients were randomized (105 to EUS+ERCP, 103 to ERCP alone). In the EUS+ERCP group, ERCP was avoided in 18 patients (17.1%) because EUS findings precluded the need for intervention. Among patients who proceeded to ERCP, the strategy concordance rate was significantly higher in the EUS+ERCP group (78/87, 89.7%) than in the ERCP alone group (74/103, 71.8%) (P = 0.002). The EUS+ERCP group also had significantly lower fluoroscopy time, radiation dose, DAP (Dose area product), and ERCP procedure time (P < 0.05). No significant differences were observed between groups in technical success, difficult cannulation, total procedure time, or complication rates (all P>0.05).
Conclusion
Performing EUS prior to ERCP significantly improves concordance between the interventional strategy and the procedure, safely reduces unnecessary ERCP procedures, and lowers radiation exposure. These findings suggest that pre-procedural EUS should be considered, when feasible, for patients with an indication for ERCP to optimize clinical decision-making.