Randomized comparison of precut papillotomy and endosonography guided rendezvous procedure for difficult biliary access in Malignant distal biliary obstruction

Background and Aims: Difficult biliary cannulation (DBC) is a marker for prolonged procedure time and increased adverse event rate (AER) during endoscopic retrograde cholangiopancreatography (ERCP). We previously showed that EUS-guided rendezvous procedure (EUS-RV) had a higher single session success rate than precut papillotomy (PcP) in DBC patients. The present randomized study aims at comparing the technical success and AER between the two approaches. Methods: This was an open label randomized controlled trial at a tertiary care setting. Patients with Malignant distal biliary obstruction and DBC were enrolled. The patients were randomized to PcP with needle knife or EUS-RV. The primary outcome was technical success, secondary outcomes were AER, procedure duration and length of hospital stay (LOS). Results: A total of 208 patients were enrolled, 104 in each group. There was no statistically significant difference in technical success (93.27% PcP vs 97.12% EUS-RV, p=0.33, 95%CI: 0.104-1.63) and overall AER (11.54% PcP vs 5.77% EUS-RV, p=0.14, 95%CI: 0.77-5.91). Pancreatitis was higher in the PcP group (8.65% vs 1.92%, p=0.058, OR= 4.83, 95%CI: 1.02-22.93). Mean duration of procedure was significantly higher for EUS-RV (47.15mins vs 27.17 min, p<0.00001, 95%CI: 18.6821.94). LOS was similar in the two groups (1.216 PcP vs 1.109 days EUS-RV, p =0.249). Conclusion: Both PcP and EUS-RV have comparable success, AER, mortality, and LOS. EUS RV could be used as an alternative to PcP in patients with malignant distal biliary obstruction and DBC.