Combination of ERCP and EUS-guided Biliary Drainage versus PTBD for Malignant Hilar Biliary Obstruction: A Multicenter Observational Open-Label Study.

Background and aim: ERCP may not provide complete biliary drainage (BD) in patients with Bismuth III and IV malignant hilar biliary obstruction (MHBO). Complete BD is accomplished by adding percutaneous transhepatic biliary drainage (PTBD). We prospectively compared recurrent biliary obstruction (RBO) rates between combined ERCP and EUS-BD (either EUS-guided hepaticogastrostomy or EUS-guided hepatico duodenostomy), versus bilateral PTBD, in MHBO. Patients and methods: Patients presenting to endoscopy services for MHBO management underwent endoscopic procedures (Group A), and were compared to those presenting to interventional radiology services who underwent bilateral PTBD (Group B). Primary outcome was the 3-month RBO rate. Results: 36 patients were recruited into groups A (n=19) and B (n=17). Overall technical success, clinical success, and complication rates of group A versus B were 84.2% (16/19) vs 100% (17/17) (p=0.23), 78.9% (15/19) vs 76.5% (13/17) (p=1), and 26.3 (5/19) vs 35.3 (6/17) (p=0.56), respectively. Within 3 and 6 months, RBO rates of group A versus B were 26.7% (4/15) versus 88.2% (15/17), p=0.001, and 22.2% (2/9) versus 100% (9/9), p=0.002, respectively. At 3 months, median number of biliary re-intervention procedures in group A was significantly lower than B (0; IQR 0-1 vs 1; IQR 1-2.5) respectively) (p<0.001). Median time to development of RBO was longer in group A than B [92 (56-217) vs 40 (13.5-57.8) days, respectively; p=0.06]. Conclusions: A combination of ERCP and EUS procedures provided significantly lower RBO rates at 3 and 6 months compared to bilateral PTBD, with same complication rate and without a significant mortality difference.