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

Area of Science:

• Gastroenterology
• Interventional Endoscopy
• Biliary Interventions

Background:

• Endoscopic retrograde cholangiography (ERC) failure necessitates alternative treatments.
• EUS-guided biliary drainage (EUS-BD) is a rescue therapy and emerging primary treatment for malignant biliary obstruction.
• Precise wire advancement is critical for successful EUS-BD after needle puncture.

Purpose of the Study:

• To evaluate the safety and efficacy of a novel steerable EUS access system.
• To assess the device's performance in controlling wire advancement during EUS-BD.
• To determine the feasibility of the system in patients with failed ERC.

Main Methods:

• Retrospective analysis of prospectively acquired data from 3 academic hospitals.
• Inclusion of consecutive patients undergoing EUS-BD with the steerable access system after failed ERC.
• Primary outcomes: safety and technical feasibility; Secondary outcomes: clinical success and device performance.

Main Results:

• 100% success in needle puncture and selective wire advancement (22/22).
• 95% technical success rate for EUS-BD (21/22).
• Low adverse event rate (4.5%) with no bile leaks, bleeding, or deaths at 30 days.

Conclusions:

• The steerable access system is safe and effective for EUS-BD.
• The device provides excellent control over wire advancement, a key challenge in EUS-BD.
• This system represents a significant advancement for managing distal malignant biliary obstruction.