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

Il Sang Shin; Jong Ho Moon; Yun Nah Lee; Jun Ho Myeong; Tae Hoon Lee; Jae Kook Yang; Young Deok Cho; Sang-Heum Park; Marc Giovannini

doi:10.1016/j.gie.2023.07.020

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

Gastrointest Endosc. 2023 Nov;98(5):848-856. doi: 10.1016/j.gie.2023.07.020. Epub 2023 Jul 18.

Authors

Il Sang Shin¹, Jong Ho Moon¹, Yun Nah Lee¹, Jun Ho Myeong¹, Tae Hoon Lee², Jae Kook Yang², Young Deok Cho³, Sang-Heum Park², Marc Giovannini⁴

Affiliations

¹ Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon, South Korea.
² Cheonan, South Korea.
³ Seoul, South Korea.
⁴ Endoscopy Unit, Paoli Calmettes Institute, Marseille, France.

PMID: 37473968
DOI: 10.1016/j.gie.2023.07.020

Abstract

Background and aims: EUS-guided hepaticogastrostomy (EUS-HPG) has a risk of serious procedural adverse events (AEs), but few dedicated devices for EUS-HPG are available. We evaluated the feasibility of a new partially covered self-expandable metal stent (PCSEMS) with an anchoring flange for EUS-HPG.

Methods: 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-HPG for unresectable malignant biliary obstruction. Primary outcomes were the technical and clinical success of EUS-HPG, and secondary outcomes were AEs, recurrent biliary obstruction (RBO), reintervention for RBO, and the technical feasibility of peroral cholangioscopy (POC) through the stent in situ.

Results: EUS-HPG was performed in 24 patients with unresectable malignant biliary obstruction. The technical and clinical success rates of EUS-HPG were 100% (24/24) and 91.7% (22/24), respectively. AEs developed after EUS-HPG in 8.3% of patients (2/24, cholangitis). RBO developed in 29.2% of 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). Reintervention for RBO had a 100% success rate (7/7), and POC through the stent in situ was technically feasible in 7 of 8 patients with a stent diameter of 10 mm.

Conclusions: EUS-HPG 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 HPG route.