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

Gastrointest Endosc. 2020 Jan;91(1):178-184. doi: 10.1016/j.gie.2019.07.035. Epub 2019 Aug 10.


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.

MeSH terms

  • Aged
  • Cholangiopancreatography, Endoscopic Retrograde
  • Choledochostomy / instrumentation*
  • Cholestasis / etiology
  • Cholestasis / pathology
  • Cholestasis / surgery*
  • Drainage / instrumentation*
  • Endosonography / instrumentation*
  • Female
  • Gastrostomy / instrumentation*
  • Humans
  • Male
  • Middle Aged
  • Retrospective Studies
  • Treatment Outcome