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

Post written by Vivek Kumbhari, MD, from the Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA. Kumbhari_headshot

EUS-guided biliary drainage (EUS-BD) is an accepted method to treat biliary pathology in those that have failed ERCP. A recent consensus statement recommended that of the 4 major EUS-BD techniques, EUS-guided rendezvous should be the initial approach if the anatomy allows.

This study evaluated a steerable access device (“Access Needle”) that was designed to facilitate improved technical and clinical outcomes for patients who undergo extrahepatic EUS-guided biliary drainage. The Access Needle is conceivably superior to the standard straight 19-guage EUS-FNA needle due to its steerability to promote selective guidewire advancement, anchoring in the bile duct, and decrease the risk of wire shearing.

This is the first reported clinical experience of the Access Needle and was required to assess its feasibility, safety, and efficacy. The rationale behind the device design is logical; however, it required evaluation in a clinical study.

Consecutive patients who had failed ERCP followed by EUS-BD using the access device were included. 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-day follow-up.

The Access Needle is an excellent system to facilitate extrahepatic biliary access such as EUS-guided rendezvous and EUS-guided choledochoduodenostomy. In particular, the steerable needle was well visualized both sonographically and fluoroscopically to aid in directing the needle tip towards the direction of interest. The ability to easily advance the wire in the direction of the papilla using the steerable needle and then flipping it back up to the intrahepatics can be used to salvage those patients where the wire simply did not cross the papilla.

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Figure 1. A, Steerable access system for EUS-guided biliary drainage. B, Sharp stylet. C, Upon stylet removal, cannula tip assumes a predetermined curvature.

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