Introduction
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 (1, 2). 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 (3). 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.
Aims & Methods
Aim of this study was to assess the safety and feasibility of EUS-HGS in patients with an inoperable malignant biliary obstruction, with the use of this dedicated stent. This prospective single-center study included patients with inoperable malignant biliary obstruction that underwent an EUS-HGS. 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 10cmx10mm 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 rate were evaluated as secondary endpoints, defined as successful deployment of the stent in the intended location and at least 50% decrease of bilirubin <14 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 by EUS-HGS. No severe periprocedural 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 obstruction of the bile duct branches by the covered part of the stent, for which an endoscopic re-intervention was performed replacing the Giobor stent by a fully covered and uncovered SEMS. Five patients died within 30 days due to fulminant disease progression. None of these patients experienced procedural related AEs. Clinical success was achieved in 18/19 (95%) patients with technical success and follow-up of at least two weeks. Six out of the 18 patients with clinical success developed recurrent biliary obstruction after a mean of 105 days (SD 80). Obstruction was caused by hyperplasia at the uncovered portion of the stent (n=3) and due to sludge obstructing the stent (n=3). Successful re-intervention was performed in all patients.
Conclusion
This prospective study shows that EUS-HGS with a dedicated partially covered stent is feasible and safe. Tissue hyperplasia in the uncovered part of the stent and sludge obstruction may compromise long-term stent patency. Larger, comparative studies addressing stent design and timing of EUS-HGS are eagerly awaited.
References
1. Pawa, S., et al., American Society for Gastrointestinal Endoscopy guideline on the role of therapeutic EUS in the management of biliary tract disorders: summary and recommendations. Gastrointest Endosc, 2024.
2. van der Merwe, S.W., et al., Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy, 2022. 54(2): p. 185-205.
3. Binda, C., et al., Efficacy and safety of endoscopic ultrasound-guided hepaticogastrostomy: a meta-regression analysis. Endoscopy, 2024. 56(9): p. 694-705