EUS-guided Hepaticogastrostomy using a novel dedicated partially covered stent in Patients with Malignant Biliary Obstruction (EPSILON); a prospective cohort study

Aims EUS-guided hepaticogastrostomy (EUS-HGS) is a novel technique that allows internal drainage of the biliary system via the stomach. This approach may be of value in patients with duodenal obstruction, surgically altered anatomy, or in hilar strictures with inadequate drainage of the left hepatic duct by other techniques. However, this procedure has a high technical complexity and until recently no dedicated stents were available exposing the patient to adverse events such as the risk of biliary leakage and stent migration. A partially covered self-expanding metallic stent (pcSEMS) with anti-migration flaps may overcome these risks. So far, the available data on the use of this specific stent is limited, and prospective studies are particularly missing. Aim of this study was to assess the safety and feasibility of EUS-HGS in patients with inoperable malignant biliary obstructions, with the use of this dedicated stent.

Methods Prospective single center study including patients with inoperable malignant biliary obstruction who were scheduled to undergo EUS-HGS for a symptomatic biliary obstruction. Patients were ineligible in case of uncontrolled coagulopathy, tumor infiltration in the gastric wall, intervening blood vessels or extensive amount of ascites. Procedure was performed with a pcSEMS (Giobor stent, Taewoong Medical). Primary outcome was safety, defined as rate of procedural related adverse events (AEs) and mortality<30 days. Technical and clinical success rates were evaluated as secondary endpoints, defined as successful deployment of the stent in the intended location and at least 50% decrease of bilirubin and/or relieve of symptoms<30 days.

Results Between January 2022 and July 2024, 25 patients (14 female [56%], median age 70 years [IQR 64-76]) were included. Reason to perform EUS-HGS included duodenal obstruction (n=12), altered anatomy (n=6) or failed drainage of the left hepatic duct by ERCP (n=7). In 21/25 patients EUS-HGS was technically successful (84%). In one patient the procedure was aborted due to a self-limiting bleeding after puncture of the bile duct, in one patient due to unsuccessful cannulation of the central bile duct and in two patients the cholangiogram showed previously unidentified intrahepatic strictures that precluded adequate drainage. No serious per procedural AEs occurred. Three patients (14%) were re-admitted with presumed cholangitis<30 days after the procedure; two with undrained right-sided bile ducts for which a percutaneous drain was placed, and one patient due to a partial proximal stent migration for which a successful endoscopic re-intervention was performed. No other serious AEs occurred<30 days. Five patients died<30 days due to fulminant disease progression. None of these patients experienced potential procedural related AEs. Clinical success was achieved in 18/19 patients with technical success and follow-up of at least two weeks.

Conclusions This prospective study shows that EUS-HGS with a dedicated partially covered stent is feasible and safe and mitigates the risk of biliary leakage and stent migration.

Publication History

Article published online:
27 March 2025