Preliminary feasibility study of a new partially covered self-expandable metal stent with an anchoring flange for EUS-guided hepaticogastrostomy (with videos)

Abstract

Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) has a risk of serious procedural adverse events (AEs), but few dedicated devices for EUS-HGS are available. We evaluated the feasibility of a new partially covered self-expandable metal stent (PCSEMS) with an anchoring flange for EUS-HGS. The feasibility of a stent featuring a proximal radiopaque uncovered portion 1.5 cm in length and a distal anchoring flange 20 mm in diameter was evaluated in consecutive patients undergoing EUS-HGS for unresectable malignant biliary obstruction. The primary outcome was technical and clinical success with regard to the EUS-HGS, and the secondary outcomes were adverse events (AEs), recurrent biliary obstruction (RBO), re-intervention for RBO, and the technical feasibility of peroral cholangioscopy (POC) through the stent in situ. EUS-HGS was performed in 24 patients with unresectable malignant biliary obstruction. The technical and clinical success rates of EUS-HGS were 100% (24/24) and 91.7% (22/24), respectively. AEs developed after EUS-HGS in 8.3% of the patients (2/24, cholangitis). RBO developed in 29.2% of the patients (7/24), with a median cumulative time to RBO of 6.7 months. The causes of RBO were sludge formation (n = 4), hyperplasia at an uncovered portion (n = 2), and nonocclusive cholangitis (n = 1). Re-intervention for RBO had a 100% success rate (7/7), and POC through the stent in situ was technically feasible in seven out of eight patients with a stent diameter of 10 mm. EUS-HGS with a new PCSEMS can alleviate malignant biliary obstruction after failed ERCP. The novel stent evaluated in this study may prevent stent-related AEs including stent migration and allow advanced endoscopic interventions through the HGS route.