Balloon Enteroscopy‐Assisted ERCP Versus Endoscopic Ultrasound‐Guided Biliary Drainage for Unresectable Malignant Biliary Obstruction in Patients With Surgically Altered Anatomy: A Multicenter Prospective Registration Study

Background and Aims The present prospective multicenter clinical trial compared the efficacy and safety of balloon enteroscopy‐assisted endoscopic retrograde cholangiopancreatography (BEA‐ERCP) and endoscopic ultrasound‐guided biliary drainage (EUS‐BD) as primary drainage methods for patients with surgically altered anatomy (SAA) and unresectable malignant biliary obstruction (MBO). Methods Technical and clinical success rates, procedure time, adverse events (AEs), and time to recurrent biliary obstruction (TRBO) were compared. Risk factors associated with technical failure were evaluated, and subgroup analysis investigating whether Roux‐en‐Y reconstruction affected the technical success rate was also performed. Results Patient characteristics were comparable between the BEA‐ERCP ( n = 54) and EUS‐BD ( n = 44) groups. Compared with the BEA‐ERCP group, the EUS‐BD group had a significantly higher technical success rate, a significantly shorter procedure time, comparable rates of clinical success and AEs, and comparable TRBO. Multivariate analysis showed that BEA‐ERCP was an independent predictor of technical failure. Subgroup analysis revealed that the technical success rate was significantly higher with EUS‐BD than with BEA‐ERCP in patients with Roux‐en‐Y reconstruction, with no significant difference in those without Roux‐en‐Y reconstruction. Conclusions EUS‐BD may be a more suitable primary drainage method than BEA‐ERCP for patients with SAA and unresectable MBO, especially those with Roux‐en‐Y reconstruction (University Hospital Medical Information Network 000049224). Trial Registration UMIN000049224