Prospective evaluation of a treatment algorithm with enhanced guidewire manipulation protocol for EUS-guided biliary drainage after failed ERCP (with video).

BACKGROUND: EUS-guided biliary drainage (EUS-BD) was introduced as an effective alternative to percutaneous transhepatic biliary drainage after failed ERCP. However, EUS-BD is technically challenging. The intraductal manipulation of the guidewire seems to be the most difficult stage of the procedure. Therefore, technical advances in guidewire manipulation may be required for EUS-BD.

OBJECTIVE: To evaluate our treatment algorithm for guidewire manipulation protocol for EUS-BD after failed ERCP.

DESIGN: Prospective, observational cohort study.

SETTING: A tertiary-care academic center.

PATIENTS: Forty-five consecutive patients undergoing EUS-BD failed ERCP.

INTERVENTIONS: Enhanced guidewire manipulation protocol (with a plane parallel to the long axis of the bile duct with an EUS needle tip or a new 0.025-inch guidewire in an extrahepatic approach and intrahepatic bile duct puncture of segment 2 and 4F cannula with guidewire probing in the intrahepatic approach) for rendezvous and antegrade therapy, EUS-BD with transluminal stenting for duodenal invasion, and crossover to another technique if each technique failed.

MAIN OUTCOME MEASUREMENTS: Technical and functional success rates and adverse event rate of the current treatment algorithm for EUS-BD.

RESULTS: The overall technical and functional success rates of EUS-BD in this study were 91% (intention to treat, n = 41/45) and 95% (per protocol, n = 39/41), respectively. Specifically, rendezvous (n = 20) and antegrade therapy (n = 14) were initially feasible in 34 of 45 patients (76%). With our protocol, 25 of 45 patients (56%) were eventually treated with rendezvous and antegrade therapy as a first-line or crossover treatment. EUS-guided biliary drainage with transluminal stenting in patients with duodenal invasion or failed antegrade therapy was feasible in the remaining 20 patients (44%). The overall adverse event rate of EUS-BD was 11%.

LIMITATIONS: Single-operator, nonrandomized study.

CONCLUSIONS: In this prospective study, our treatment algorithm with an enhanced guidewire manipulation protocol appeared to be technically feasible and effective. Given the favorable success rate and acceptable adverse event rate, this may be considered the standard treatment algorithm for future randomized trials of EUS-BD and percutaneous transhepatic biliary drainage.