Endoscopic ultrasound-guided transpapillary versus transluminal biliary stenting: randomized comparison of long-term stent patency

Background: Endoscopic ultrasound-guided biliary drainage (EUS-BD) may be transluminal (choledochoduodenostomy [CDS] and hepaticogastrostomy [HGS]) or transpapillary via an antegrade approach; it is unclear which route is preferred. We conducted a multicenter randomized study comparing the two routes. Methods: In this open-label randomized study from five tertiary centers, patients with unresectable malignant biliary obstruction and failed endoscopic retrograde cholangiopancreatography were randomized to either EUS-CDS/HGS or transpapillary stenting. The primary outcome was stent patency (recurrent biliary obstruction), assessed at 1, 3, 6, and 12 months. Analysis was on a per-protocol basis. Results: 120 patients (67 males) were recruited (November 2021 to March 2024), with 60 patients in each arm (24 CDS, 36 HGS). The median time to recurrent biliary obstruction was 294 days (95%CI 257.95-330.04) in the transpapillary group and 219 days (95%CI 122.45-315.54) in the transluminal group (P = 0.03). At 3 months, 11/54 stents (20.4%) were blocked in the transluminal group versus 3/52 (5.8%) in the transpapillary group (odds ratio [OR] 0.24, 95%CI 0.06-0.91; P = 0.04). At 6 months, 21/54 stents (38.9%) were blocked in the transluminal group versus 11/52 (21.2%) in the transpapillary group (OR 0.42, 95%CI 0.18-0.99; P = 0.04). There were 13 (21.7%) adverse events in the transluminal group (one death), and 8 (13.3%) in the transpapillary group (OR 0.57, 95%CI 0.21-1.46; P = 0.33). Conclusion: Transpapillary EUS-BD achieved longer stent patency and a lower rate of recurrent biliary obstruction at 3 and 6 months compared with the transluminal route.