Endoscopic ultrasound-guided trans-papillary versus trans-luminal biliary stenting: Randomized comparison of long term stent patency

Background and study aims: The two routes of EUS-guided biliary drainage(EUS-BD) are trans-luminal(TL) (choledocho-duodenostomy(CDS) and hepatico-gastrostomy(HGS)) and trans-papillary(TP) via an antegrade approach(AG). It is unclear whether TP or TL drainage should be preferred. We conducted a multicenter randomized study to compare the two routes. Patients and Methods: In this open label randomized study from 5 tertiary care centers, patients with unresectable malignant biliary obstruction and failed ERCP were randomized into receiving either EUS-guided transluminal (CDS or HGS) or transpapillary stenting (AG). Primary outcome was stent patency (recurrent biliary obstruction), assessed at 1,3,6, and 12 months. Analysis was done on per protocol basis. Results: 120 patients (67 males) were recruited from November 2021 to March 2024. There were 60 patients each in the TL (24CDS,36HGS) and TP arm. Median time to recurrent biliary obstruction was 294 days (95%CI 257.95 – 330.04) for TP group and 219 days (95% CI 122.45- 315.54) for TL group (p=0.03). At three months, 11 stents (20.37%) blocked in the TL group compared to three (5.77%) in the TP group (OR=0.24, 0.06-0.91, p=0.04). At six months, 21 (38.89%) stents blocked in the TL arm compared to 11 (21.15%) in the TP arm (OR=0.42, 0.17-0.99. P=0.04). There were 13 (21.66%) adverse events in the TL group (one death), and 8 (13.33%) in the TP group (OR=0.57,0.21-1.46. P=0.33). Conclusion: EUS-BD via TP route achieved longer stent patency and lower rate of recurrent biliary obstruction at 3 and 6 months compared to TL route.