Randomized comparison of precut papillotomy versus an endoscopic ultrasound-guided rendezvous procedure for difficult biliary access in malignant distal biliary obstruction.

Background: Difficult biliary cannulation (DBC) is a marker for prolonged procedure time and a higher rate of adverse events (AEs) during endoscopic retrograde cholangiopancreatography (ERCP). We previously showed that endoscopic ultrasound-assisted rendezvous (EUS-RV) procedures had a higher single-session success rate than precut papillotomy (PCP) in cases of DBC. The present randomized study aimed to compare the technical success and AE rates of the two approaches.

Methods: This was an open-label randomized controlled trial in a tertiary care setting. Patients with malignant distal biliary obstruction (MDBO) and DBC were enrolled. The patients were randomized to PCP with a needle-knife or EUS-RV. The primary outcome was technical success; secondary outcomes were the AE rate, procedure duration, and length of hospital stay (LOS).

Results: 208 patients were enrolled, 104 in each group. There were no statistically significant differences in technical success (93.3% PCP vs. 97.1% EUS-RV; P = 0.33; odds ratio [OR] 0.4, 95%CI 0.1–1.6) and overall AE rate (11.5% PCP vs. 5.8% EUS-RV; P=0.14; OR 0.5, 95%CI 0.8–5.9). Pancreatitis was higher in the PCP group (8.7% vs. 1.9%; P=0.06; OR 4.8, 95%CI 1.0–22.9). The mean duration of the procedure was significantly higher for EUS-RV (47 vs. 27 minutes; P<0.001). LOS was similar in the two groups (1.2 PCP vs. 1.1 days EUS-RV; P=0.25).

Conclusion: Both PCP and EUS-RV have comparable rates of success, AEs, mortality, and LOS. EUS-RV could be used as an alternative to PCP in patients with MDBO and DBC.