Randomized comparison of EUS-guided trans-papillary or trans-luminal biliary stenting for Type I Hilar malignant biliary obstruction in patients with failed ERCP

Aims EUS-guided biliary drainage for palliation of malignant biliary obstruction offers the advantage of multiple access and exit routes, and has emerged as a viable option for patients after failed ERCP. The two main routes of drainage are trans-luminal (TL, choledocho-duodenostomy (CDS) and hepatico-gastrostomy (HGS), and trans-papillary (TP) via an antegrade approach (AG). There is an expectation that trans-luminal route should provide longer stent patency as the stent does not traverse the tumor. There is no data on the preferred EUS-BD technique for Hilar blocks. We conducted a multicenter randomized study to compare the short and long term outcomes of the two routes.

Methods In this open label randomized study from 5 centers, patients with unresectable malignant biliary obstruction (distal and type I hilar) and failed ERCP were randomized into receiving either TL (CDS or HGS) or TP stenting (AG). Magnetic resonance cholangio-pancreatography was used to determine the type of hilar block. The primary outcome was stent patency, while secondary outcome measures were time to recurrent biliary obstruction (TRBO), technical success (TS), clinical success (CS) and adverse event rate (AER). These patients were followed up for a median of 251 days (IQR174). A subset of patients with Type I hilar block were analysed for this study.

Results 120 patients were recruited over a 3years period, 41 with type I hilar block (21-HGS, 20-AG). No significant difference was found in the TS and CS between distal and hilar blocks (TS 92.4% vs 92.6%, p=1, CS 91.1% vs 82.9%, p=0.2). The AER were significantly higher for hilar blocks (31.7% vs 10.1%, p=0.006). There was no significant difference in TS (21 (100%) vs 17 (85%), p=0.107, OR 1.18, 95%CI 0.979-1.414) and CS (19 (90.48%) vs 15 (75%), p=0.238, OR 3.18, 95%CI 0.537-18.667) for hilar block patients with TL or TP route. There was no significant difference between the AER (7 (33.33%) vs 6 (30%), p=0.82, OR 0.86, 95%CI 0.229-3.203). One patient (4.76%) died on day 6 in the TL(HGS)group. The rate of stent block was lower for TP group, but did not reach statistical significance, at 1month (9.52% vs 0%, p=0.49), 3month (14.29% vs 5%, p=0.61) and 6month (23.81% vs 5%, p=0.18). The mean TRBO was 91 days longer in the TP arm (323.35 vs 232.65days, p=0.053).

Conclusions EUS guided biliary drainage for Type I Hilar block is safe and effective, and has similar technical and clinical success rates but significantly higher AER compared to distal blocks. Both transluminal (HGS) and transpapillary (AG) procedures have equivalent technical and clinical success and adverse event rates for hilar blocks. The stent patency is longer for transpapillary route but did not reach statistical significance.

 

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Conflicts of Interest

Authors do not have any conflict of interest to disclose.

Publication History

Article published online:
27 March 2025