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. 2023 Jan-Feb;12(1):59-63.
doi: 10.4103/EUS-D-22-00023.

Feasibility and safety of a new dedicated biliary stent for EUS-guided hepaticogastrostomy: The FIT study (with video)

Andrea Anderloni  1 , Alessandro Fugazza  1 , Marco Spadaccini  2 , Matteo Colombo  2 , Antonio Capogreco  2 , Silvia Carrara  1 , Roberta Maselli  1 , Elisa Chiara Ferrara  1 , Piera Alessia Galtieri  1 , Gaia Pellegatta  1 , Alessandro Repici  2
Affiliations

Feasibility and safety of a new dedicated biliary stent for EUS-guided hepaticogastrostomy: The FIT study (with video)

Andrea Anderloni et al. Endosc Ultrasound. 2023 Jan-Feb.

Abstract

Background and objectives: EUS-guided biliary drainage (BD) through hepaticogastrostomy (HGS) is an option in case of ERCP failure. Available data suggest that this procedure may be challenging with possible severe adverse events (AEs) mainly due to stent migration. The aim of our pilot study was to prospectively assess the technical and clinical outcomes of EUS-HGS using a new dedicated partially covered self-expandable metal stent with anti-migratory systems.

Methods: This is a single-center prospective study enrolling patients with malignant biliary obstruction undergoing EUS-HGS after failed ERCP, between June 2020 and March 2021. The primary endpoint was the technical success rate. Evaluation of specific stent-related technical features as compared with commonly used self-expandable metal stent, clinical success rate, and procedure-related AEs was also assessed.

Results: Twenty-two patients (15%-68.2%, female; mean age, 66.0 ± 10.0) were enrolled in the study analysis. Different causes of ERCP failure were infiltration of papilla by neoplastic tissue (4, 18.2%), unreachable papilla for duodenal stricture (9, 40.9%), surgically altered anatomy with Roux-en-Y reconstruction (4, 18.2%), and incomplete BD after transpapillary stent placement (5, 22.7%). Technical success was achieved in all patients, in a mean procedural time of 43.3 ± 26.8 min. Technical features were graded as high or medium in all cases. The clinical success rate was 91% (20/22, mean follow-up: 10.8 ± 3.1 months). There were no cases of stent misplacement or stent migration. Three (13.6%) cases of a hepatic abscess requiring percutaneous drainage and systemic antibiotics were reported, with no impact on clinical success and following oncologic treatments. No deaths occurred.

Conclusion: EUS-HGS with a new dedicated stent with anti-migratory systems is feasible and effective, preventing stent migration, and misplacement. Although the persistent procedural challenges, dedicated devices may contribute to outcomes improvement and procedure diffusion.

Keywords: Biliary tract; intervention EUS; pancreatobiliary.

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Conflict of interest statement

None

Figures

Figure 1
Figure 1
PCSEMS (Hanarostent BPE, M.I. Tech, Korea). PCSEMS: Partially covered self-expandable metal stent
Figure 2
Figure 2
PCSEMS. Endoscopic view. PCSEMS: Partially covered self-expandable metal stent
Figure 3
Figure 3
Study flowchart. *Unreachable papilla: 9; incomplete biliary drainage: 5; infiltrated papilla: 4; altered anatomy: 4
Figure 4
Figure 4
PCSEMS. Fluoroscopic view. PCSEMS: Partially covered self-expandable metal stent
See this image and copyright information in PMC

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