ERCP plus endoscopic ultrasound-guided biliary drainage versus percutaneous transhepatic biliary drainage for malignant hilar biliary obstruction: a multicenter observational open-label study.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) may not provide complete biliary drainage in patients with Bismuth III/IV malignant hilar biliary obstruction (MHBO). Complete biliary drainage is accomplished by adding percutaneous transhepatic biliary drainage (PTBD). We prospectively compared recurrent biliary obstruction (RBO) rates between combined ERCP and endoscopic ultrasound-guided biliary drainage (EUS-BD) vs. bilateral PTBD. METHODS: Patients with MHBO undergoing endoscopic procedures (group A) were compared with those undergoing bilateral PTBD (group B). The primary outcome was the 3-month RBO rate. RESULTS: 36 patients were recruited into groups A (n = 19) and B (n = 17). Rates of technical and clinical success, and complications of group A vs. B were 84.2 % (16/19) vs. 100 % (17/17; P = 0.23), 78.9 % (15/19) vs. 76.5 % (13/17; P > 0.99), and 26.3 % (5/19) vs. 35.3 % (6/17; P = 0.56), respectively. Within 3 and 6 months, RBO rates of group A vs. group B were 26.7 % (4/15) vs. 88.2 % (15/17; P  = 0.001) and 22.2 % (2/9) vs. 100 % (9/9; P = 0.002), respectively. At 3 months, median number of biliary reinterventions in group A was significantly lower than in group B (0 [interquartile range] 0-1 vs. 1 [1-2.5]), respectively (P < 0.001). Median time to development of RBO was longer in group A than in group B (92 [56-217] vs. 40 [13.5-57.8] days, respectively; P  =  0.06). CONCLUSIONS: Combined ERCP and EUS procedures provided significantly lower RBO rates at 3 and 6 months vs. bilateral PTBD, with similar complication rates and no significant mortality difference.