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Initial clinical experience of a steerable access device for EUS-guided biliary drainage

  • Marvin Ryou
    Affiliations
    Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA
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  • Petros C. Benias
    Affiliations
    Division of Gastroenterology, Northwell Health, North Shore University Hospital, Manhasset, New York, USA
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  • Vivek Kumbhari
    Correspondence
    Reprint requests: Vivek Kumbhari, MD, Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Sheikh Zayed Building, 1800 Orleans St, Suite 7125G, Baltimore, MD 21287.
    Affiliations
    Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
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Published:August 10, 2019DOI:https://doi.org/10.1016/j.gie.2019.07.035

      Background and Aims

      EUS-guided biliary drainage (EUS-BD) has been used as a rescue procedure after failed endoscopic retrograde cholangiography (ERC), and there is growing interest in EUS-BD as a primary therapy for distal malignant biliary obstruction. After EUS-guided needle puncture of an obstructed bile duct, directional control of wire advancement remains an area of need, potentially addressed by a new steerable EUS access system. The aim of this study was to evaluate the safety and efficacy of this novel steerable access system in patients undergoing EUS-BD after failed ERC.

      Methods

      We performed a retrospective study of prospectively acquired data at 3 tertiary academic hospitals. Consecutive patients who had failed ERC followed by EUS-BD using the access device were included. Primary outcomes were safety and technical feasibility (successful completion of EUS-BD). Secondary outcomes were clinical success (75% improvement in liver function tests at 30 days) and device performance.

      Results

      Twenty-two consecutive patients underwent EUS-BD between October 10, 2018 and March 3, 2019. Needle puncture and selective wire advancement in the intended direction were both successful in 100% of cases (22/22). Technical success was 95% (21/22). Fifty-nine percent (13) underwent rendezvous, 32% (7) underwent choledochoduodenostomy, and 4.5% (1) underwent hepaticogastrostomy. One patient (4.5%) underwent percutaneous transhepatic cholangiography. There were no cases of wire shearing. The adverse event rate was 4.5% (mild pancreatitis in 1 patient). There was no bile leak, bleeding, or death at 30 days' follow-up.

      Conclusions

      This first clinical experience with a steerable access system for EUS-BD suggests it is safe and effective, particularly with regard to controlling direction of wire advancement.

      Abbreviations:

      CDS (choledochoduodenostomy), ERC (endoscopic retrograde cholaniography), EUS-BD (EUS-guided biliary drainage), FDA (U.S. Food and Drug Administration), HGS (hepaticogastrostomy), PTBD (percutaneous transhepatic biliary drainage), RDV (rendezvous)
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